Preoperative Levator Ani Muscle Injection and Pudendal Ne... | NCT03040011

Name	Class
Magee-Women's Research Institute	OTHER

Label	Type	Description	Intervention Names
Bupivacaine/Dexamethasone Arm	Experimental	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites.	Drug: Dexamethasone Drug: Bupivacaine Procedure: Bilateral Pudendal Nerve Block Procedure: Bilateral Levator Ani Muscle Injection
Bupivacaine Arm	Active Comparator	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites.	Drug: Bupivacaine Procedure: Bilateral Pudendal Nerve Block Procedure: Bilateral Levator Ani Muscle Injection
Placebo Arm	Placebo Comparator	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen (transobturator). After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites.

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.	Bupivacaine/Dexamethasone Arm

Measure	Description	Time Frame
Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)	Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.	24 hours postoperatively

Measure	Description	Time Frame
6 Hour Postoperative Pain Measured by the NRS	Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain. Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section.

Name	Affiliation	Role
Lauren Giugale, MD	University of Pittsburgh	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Magee-Womens Hospital of UPMC		Pittsburgh	Pennsylvania	15213	United States

PubMed Identifier	Type	Citation
	Background	Dexamethasone (systemic): Drug information. UpToDate; 2016. Accessed November 9, 2016.
	Background	Bupivacaine: Drug Information. UpToDate; 2016.
	Background	Hsu D. Infiltration of local anesthetics. UpToDate. 2016. Accessed November 30, 2016.
33278291	Derived	Giugale LE, Baranski LA, Meyn LA, Schott NJ, Emerick TD, Moalli PA. Preoperative Pelvic Floor Injections With Bupivacaine and Dexamethasone for Pain Control After Vaginal Prolapse Repair: A Randomized Controlled Trial. Obstet Gynecol. 2021 Jan 1;137(1):21-31. doi: 10.1097/AOG.0000000000004205.

ID	Title	Description
FG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 24, 2019

ID	Title	Description
BG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
BG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m
BG002	Placebo Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00025 BG00125 BG00225 BG00375

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)

Postoperative pain measured by the numerical rating scale (NRS) at 24 hours postoperatively. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

Posted

Median

Inter-Quartile Range

score on a scale

24 hours postoperatively

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m
OG002	Placebo Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx

Units	Counts
Participants	OG00021 OG00124 OG00224

Title

Denominators

Categories

Title	Measurements
	OG0003.0(1.0 to 5.0) OG0014.0(2.0 to 5.0) OG0023.75(2.0 to 6.5)

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001 OG002		Kruskal-Wallis		0.39														Superiority

Secondary

6 Hour Postoperative Pain Measured by the NRS

Postoperative pain as measured by the NRS at 6 hours after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

Of note, there is a typographical error in the protocol section and refers to this outcome as a NRS score at 3 hours postoperatively. The final IRB approved protocol is a 6 hour postoperative timepoint and this is the correct outcome reported here in the results section.

Posted

Median

Inter-Quartile Range

score on a scale

6 hours postoperatively

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm

Secondary

POD 2 Postoperative Pain Measured by the NRS

Postoperative Pain Measured by the NRS 2 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

Posted

Median

Inter-Quartile Range

score on a scale

2 days after surgery

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

POD 3 Postoperative Pain Measured by the NRS

Postoperative Pain Measured by the NRS 3 days after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

Posted

Median

Inter-Quartile Range

score on a scale

3 days after surgery

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

1 Week Postoperative Pain Measured by the NRS

Postoperative Pain Measured by the Numeric Rating Scale 1 week after surgery. The Numeric Rating Scale is an 11 point scale ranging from 0-10 with higher scores indicating worse pain.

Posted

Median

Inter-Quartile Range

score on a scale

1 week after surgery

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

Proportion of Patients With Same Day Discharge

Same day discharge was defined as a patient being discharged on the same day as surgery and did not require an admission after surgery. The proportion of patients who were discharged on the day of surgery was compared between groups.

Posted

Count of Participants

Participants

Day of surgery

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

Postoperative Urinary Retention

Urinary retention was defined as the need to perform self-catheterization or have an indwelling catheter placed postoperatively. The proportion of patients with urinary retention was compared between groups.

Posted

Count of Participants

Participants

0-24 hours postoperatively

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

Adverse Events

The number of adverse events in each study group was assessed and compared between study groups. An adverse event was described as any medical or surgical complication that occurred either intraoperatively or postoperatively.

Posted

Number

number of adverse events

0-12 weeks postoperatively

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

Nausea and Vomiting Measured by the PONV Scale

Intensity of postoperative nausea and vomiting (PONV) measured by the PONV scale prior to discharge. The Postoperative Nausea and Vomiting Intensity Scale is a four-question assessment to measure clinically significant nausea and vomiting with a range from 0-7 with higher scores signifying more clinically significant nausea and vomiting.

Posted

Median

Inter-Quartile Range

score on a scale

6 hours postoperatively

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm

Secondary

Anti-emetic Consumption

The amount of inpatient anti-emetic consumption, recorded in number of doses of nausea medication

This data was not collected. Rather, we assessed the PONV score which is described in outcome number 9.

Posted

3 hours postoperatively

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

Return to Baseline Activities Using the Activities Assessment Scale

Resumed normal daily activities using the Activities Assessment Scale (AAS) by 1 week after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

We defined return to normal as when a patient's postoperative AAS scores was at or greater than the baseline AAS score. We report the proportion of patients in each study arm who returned to baseline activity at each timepoint.

Posted

Count of Participants

Participants

1 week postoperative

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

Secondary

Return to Baseline Activities Using the Activities Assessment Scale

Resumed normal daily activities using the Activities Assessment Scale (AAS) by 2 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

Posted

Count of Participants

Participants

2 week postoperative

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

Secondary

Return to Baseline Activities Using the Activities Assessment Scale

Resumed normal daily activities using the Activities Assessment Scale (AAS) by 6 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

Posted

Count of Participants

Participants

6 weeks postoperative

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

Secondary

Return to Baseline Activities Using the Activities Assessment Scale

Resumed normal daily activities using the Activities Assessment Scale (AAS) by 12 weeks after surgery. The AAS is a 13-point scale on which patients rate their difficulty performing a range of activities from "No difficulty" to "Not able to do it." A final score ranging from 0-100 is transformed, with higher numbers reflecting less difficulty with activities.

Posted

Count of Participants

Participants

12 weeks postoperative

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam

Secondary

POD 1 Narcotic Consumption

The total amount of narcotic pain medication used on postoperative day 1 was calculated and measured in oral morphine equivalents.

Posted

Median

Inter-Quartile Range

oral morphine equivalents

Postoperative day 1

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

POD 2 Narcotic Consumption

The total amount of narcotic pain medication used on postoperative day 2 was calculated and measured in oral morphine equivalents.

Posted

Median

Inter-Quartile Range

oral morphine equivalents

Postoperative day 2

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

POD 3 Narcotic Consumption

The total amount of narcotic pain medication used on postoperative day 3 was calculated and measured in oral morphine equivalents.

Posted

Median

Inter-Quartile Range

oral morphine equivalents

Postoperative day 3

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

POD 1 Ibuprofen Consumption

The total amount of ibuprofen medication used on postoperative day 1.

Posted

Median

Inter-Quartile Range

milligrams

Postoperative day 1

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

POD 2 Ibuprofen Consumption

The total amount of ibuprofen medication used on postoperative day 2.

Posted

Median

Inter-Quartile Range

milligrams

Postoperative day 2

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Secondary

POD 3 Ibuprofen Consumption

The total amount of ibuprofen medication used on postoperative day 3.

Posted

Median

Inter-Quartile Range

milligrams

Postoperative day 3

ID	Title	Description
OG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam
OG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Surgical complications	Injury, poisoning and procedural complications		Systematic Assessment	Surgical complications not thought to be related to study intervention: ureteral obstruction requiring return to the operating room (n=1) and a case with a rectal injury and sponge miscount, which was resolved prior to the procedure conclusion (n=1)	EG0001 events1 affected25 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk
Asthma exacerbation	Respiratory, thoracic and mediastinal disorders		Systematic Assessment	Postoperative asthma exacerbation requiring emergency room care	EG0000 events0 affected25 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk

Term	Organ System	Assessment Type	Notes	Statistical Information
Urinary tract infection	Renal and urinary disorders	Systematic Assessment	Postoperative urinary tract infection defined as positive urine culture with symptoms	EG0002 events2 affected25 at risk EG0011 events1 affected25 at risk EG0022 events2 affected25 at risk
Excess postoperative surgical pain	Nervous system disorders	Systematic Assessment	Excessive postoperative surgical site pain that required additional visits and medications	EG0001 events1 affected25 at risk EG0011 events1 affected25 at risk EG0022 events2 affected25 at risk
Intraoperative bradycardia	Cardiac disorders	Systematic Assessment	Bradycardia that required additional medication. Occurred after anesthesia but prior to the start of the surgical procedure. Not thought to be related to study intervention.	EG0000 events0 affected25 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk
Leg numbness	Nervous system disorders	Systematic Assessment	Transient lower extremity numbness requiring extended observation and ultimately resolved spontaneously	EG0002 events2 affected25 at risk EG0011 events1 affected25 at risk EG0020 events0 affected25 at risk
Nausea and vomiting, diarrhea	Gastrointestinal disorders	Systematic Assessment	Postoperative nausea and vomiting and diarrhea on that required observation and medication administration. Not thought to be related to study intervention.	EG0000 events0 affected25 at risk EG0012 events2 affected25 at risk EG0020 events0 affected25 at risk
Fever	Infections and infestations	Systematic Assessment	Presented to emergency room with low grade fever of 100.4 Fahrenheit. Complete evaluation with no evidence of infection or other source of fever. No treatment or intervention required. Not thought to be related to study intervention.	EG0001 events1 affected25 at risk EG0010 events0 affected25 at risk EG0020 events0 affected25 at risk
Fall	Musculoskeletal and connective tissue disorders	Systematic Assessment	Fell at home one week after surgery requiring evaluation in emergency room. Not thought to be related to study intervention.	EG0000 events0 affected25 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk
Yeast Infection	Infections and infestations	Systematic Assessment	Vulvar yeast infection requiring medication. Not thought to be related to study intervention.	EG0000 events0 affected25 at risk EG0010 events0 affected25 at risk EG0021 events1 affected25 at risk
Wound infection	Infections and infestations	Systematic Assessment	Postoperative malodorous discharge and fever presumed wound infection (no culture obtained). Treated with antibiotics with symptom resolution. Not thought to be related to study intervention.	EG0000 events0 affected25 at risk EG0011 events1 affected25 at risk EG0020 events0 affected25 at risk

ID	Term
D056887	Pelvic Organ Prolapse
D010149	Pain, Postoperative

ID	Term
D011391	Prolapse
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms
D011183	Postoperative Complications
D010335	Pathologic Processes
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

ID	Term
D003907	Dexamethasone
D002123	Calcium Dobesilate
D002045	Bupivacaine
D012965	Sodium Chloride
D000077330	Saline Solution

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Bupivacaine/Dexamethasone Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of a mixture of 20 milliliters of 0.25% bupivacaine (2.5mg/milliliter ) and 2 milliliters of dexamethasone (4mg/milliliter). The total amount of the bupivacaine/dexamethasone solution will be divided equally between the four injection sites. Dexamethasone: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligam	25	1	25	6	25
EG001	Bupivacaine Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.25% bupivacaine (2.5mg/milliliter). The total amount will be divided equally between the four injection sites. Bupivacaine: Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm m	25	0	25	6	25
EG002	Placebo Arm	After sterile preparation in lithotomy position, investigators will perform bilateral levator ani muscle injection via the obturator foramen. After transobturator injections are performed on each side, bilateral pudendal nerve blocks will be performed transvaginally as described in the literature. The solution injected at all 4 of the above injections sites will consist of 20 milliliters 0.9% saline (normal saline). The total amount will be divided equally between the four injection sites. Bilateral Pudendal Nerve Block: Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approx	25	2	25	7	25

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D001557	Benzenesulfonates
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals
D001190	Arylsulfonates
D017739	Arylsulfonic Acids
D013451	Sulfonic Acids
D013456	Sulfur Acids
D013457	Sulfur Compounds
D000813	Anilides
D000577	Amides
D000814	Aniline Compounds
D000588	Amines
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds
D000077324	Crystalloid Solutions
D007552	Isotonic Solutions
D012996	Solutions
D004364	Pharmaceutical Preparations