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Effective post-surgical pain management is a crucial component of a patient's postoperative course following posterior colporrhaphy. Narcotics are the cornerstone for postoperative analgesia with a frequent re-dosing requirement, a lengthy list of side effects and adverse reaction risks. The colorectal, orthopedic and general surgery literatures have reported on an extended-release bupivacaine liposomal injection, Exparel®, which remarkably reduces acute post-operative pain; however, literature regarding this medication specific to Urogynecology and Gynecology is limited.
The investigators propose a prospective, randomized, double blind, trial with 120 subjects recruited from the Walter Reed National Military Medical Center (WRNMMC) Urogynecology Clinic to study postsurgical pain control after posterior repair. There will be two arms in the study; one arm with bupivacaine alone and a second arm with bupivacaine mixed with Exparel®(extended-release, liposomal bupivacaine) injected vaginally in patients undergoing posterior colporrhaphy. Subjects will be randomized to receive either 20 milliliter (mL) of plain bupivacaine or 20mL (10ml+10ml) mixture of bupivacaine plus Exparel®.
The primary objective of the trial will be to evaluate the postsurgical vaginal pain using a visual analog pain scale at days 1, 2, 3 post-procedure. All subjects will have acetaminophen, a non-steroidal anti-inflammatory drug and narcotic pain medication available for pain control regardless of assignment, which is the usual postoperative pain control regimen. The investigators hypothesize a 30% difference in post-operative pain measurements between the two groups.
Additional objectives of this study are to evaluate total medication usage on days 1, 2 and 3 and any post-operative voiding and defecatory dysfunction, comparing the two groups
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plain Bupivacaine | Active Comparator | 20 mL of 0.25% plain bupivacaine |
|
| Exparel plus plain bupivacaine | Active Comparator | 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel plus plain bupivacaine | Drug | 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively | Patients will be asked on postoperative day (POD) 1 to provide numerical values regarding vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale) | Subjects will be asked to provide numerical values on postoperative day 1. |
| Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively | Patients will be asked on postoperative day (POD) 2 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale) | Subjects will be asked to provide numerical values on postoperative day 2. |
| Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively | Patients will be asked on postoperative day (POD) 3 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale) | Subjects will be asked to provide numerical values on postoperative day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Amount Ibuprofen Pain Medication Required During the Postoperative Period at Home | Calculate total postoperative ibuprofen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of ibuprofen utilized at home through postoperative day #3 | Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home) |
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Inclusion Criteria:
Exclusion Criteria:
females only
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Gruber, MD | Walter Reed National Military Medical Center (WRNMMC) | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Walter Reed National Military Medical Center (WRNMMC) | Bethesda | Maryland | 20889 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34473963 | Derived | Dengler KL, Craig ER, DiCarlo-Meacham AM, Welch EK, Brooks DI, Vaccaro CM, Gruber DD. Preoperative pudendal block with liposomal and plain bupivacaine reduces pain associated with posterior colporrhaphy: a double-blinded, randomized controlled trial. Am J Obstet Gynecol. 2021 Nov;225(5):556.e1-556.e10. doi: 10.1016/j.ajog.2021.08.034. Epub 2021 Aug 30. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Plain Bupivacaine | 20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy |
| FG001 | Exparel Plus Plain Bupivacaine | 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Plain Bupivacaine | 20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy |
| BG001 | Exparel Plus Plain Bupivacaine |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | The two populations were analyzed separately. |
| 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 | Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively | Patients will be asked on postoperative day (POD) 1 to provide numerical values regarding vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale) | Posted | Median | Inter-Quartile Range | score on a scale | Subjects will be asked to provide numerical values on postoperative day 1. |
|
entirety of the study (AUG2018-AUG2020); patients were followed out to 6 weeks postoperatively
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plain Bupivacaine | 20 mL of 0.25% plain bupivacaine Bupivacaine: 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative sensory numbness/tingling in the lower extremities | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Katherine L Dengler, MD | Walter Reed National Military Medical Center | 301-400-2468 | katherine.l.dengler.mil@mail.mil |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 10, 2020 | Nov 15, 2021 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
| Bupivacaine | Drug | 20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy |
|
|
| Amount Acetaminophen Pain Medication Required During the Postoperative Period at Home | Calculate total postoperative acetaminophen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of acetaminophen utilized at home through postoperative day #3 | Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home) |
| Amount Opioid Pain Medication Required During the Postoperative Period (Through Day 3) | Calculate total postoperative opioid medications used while inpatient and perform pill counts on postoperative days 1, 2, 3 (done via a phone call or inpatient). This will allow calculation of total amount of opioid pain medications utilized through postoperative day #3 | Calculated throughout hospitalization and/or with phone call on postoperative day 1, 2, and 3 (total opioids utilized) |
| Percentage of Participants Who Passed Active Voiding Trial Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group. | Investigators will record in patients passed active voiding trail prior to discharge home. | Postoperative active voiding trial on postoperative day 1. |
| Rate of Post-operative Defecatory Function After Posterior Colporrhaphy, Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group. | Investigators will record in patients have had a bowel movement within the first three days postoperatively. | Postoperatively up to day 3 |
| Impact of Vaginal Pain Scores on Quality of Life Measures (ACTIVITY) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients "how is your vaginal pain impacting your ACTIVITY (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Subjects will be asked to provide numerical value on postoperative day 3. |
| Impact of Vaginal Pain Scores on Quality of Life Measure (SLEEP) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients "how is your vaginal pain impacting your SLEEP (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Subjects will be asked to provide numerical value on postoperative day 3. |
| Impact of Vaginal Pain Scores on Quality of Life Measure (MOOD) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients "how is your vaginal pain impacting your MOOD (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Subjects will be asked to provide numerical value on postoperative day 3. |
| Impact of Vaginal Pain Scores on Quality of Life Measure (STRESS) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients "how is your vaginal pain impacting your STRESS (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Subjects will be asked to provide numerical value on postoperative day 3. |
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed
Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
| BG002 | Total | Total of all reporting groups |
| Median |
| Inter-Quartile Range |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | The two populations were analyzed separately. | Median | Inter-Quartile Range | kg/m^2 |
|
| Gravidity | The two populations were analyzed separately. | Median | Inter-Quartile Range | pregnancies |
|
| Parity | The two populations were analyzed separately. | Median | Inter-Quartile Range | births |
|
| colpopexy | Count of Participants | Participants |
|
| hysterectomy | Count of Participants | Participants |
|
10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy |
|
|
| Primary | Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively | Patients will be asked on postoperative day (POD) 2 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale) | Posted | Median | Inter-Quartile Range | score on a scale | Subjects will be asked to provide numerical values on postoperative day 2. |
|
|
|
| Primary | Change in Vaginal Pain Scores Using the Defense and Veterans Pain Rating Scale (Visual Analog Scale) Between Bupivacaine Alone Versus Exparel® Following Posterior Colporrhaphy Post-operatively | Patients will be asked on postoperative day (POD) 3 to provide numerical values for vaginal pain from 0-10 (zero being no pain and 10 being the worst pain) utilizing the Defense and Veterans Pain Rating Scale (visual analog scale) | Posted | Median | Inter-Quartile Range | score on a scale | Subjects will be asked to provide numerical values on postoperative day 3. |
|
|
|
| Secondary | Amount Ibuprofen Pain Medication Required During the Postoperative Period at Home | Calculate total postoperative ibuprofen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of ibuprofen utilized at home through postoperative day #3 | Posted | Median | Inter-Quartile Range | milligrams | Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home) |
|
|
|
| Secondary | Amount Acetaminophen Pain Medication Required During the Postoperative Period at Home | Calculate total postoperative acetaminophen used while at home via perform pill counts on postoperative days 1, 2, 3 (done via a phone call). This will allow calculation of total amount of acetaminophen utilized at home through postoperative day #3 | Posted | Median | Inter-Quartile Range | milligrams | Calculated with phone call on postoperative day 1, 2, and 3 (total acetaminophen utilized at home) |
|
|
|
| Secondary | Amount Opioid Pain Medication Required During the Postoperative Period (Through Day 3) | Calculate total postoperative opioid medications used while inpatient and perform pill counts on postoperative days 1, 2, 3 (done via a phone call or inpatient). This will allow calculation of total amount of opioid pain medications utilized through postoperative day #3 | Posted | Median | Inter-Quartile Range | morphine milligram equivalents | Calculated throughout hospitalization and/or with phone call on postoperative day 1, 2, and 3 (total opioids utilized) |
|
|
|
| Secondary | Percentage of Participants Who Passed Active Voiding Trial Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group. | Investigators will record in patients passed active voiding trail prior to discharge home. | Posted | Number | percentage passed | Postoperative active voiding trial on postoperative day 1. |
|
|
|
| Secondary | Rate of Post-operative Defecatory Function After Posterior Colporrhaphy, Comparing the Bupivacaine Plus Exparel® Group Versus the Bupivacaine Plain Group. | Investigators will record in patients have had a bowel movement within the first three days postoperatively. | Posted | Number | percentage of patients | Postoperatively up to day 3 |
|
|
|
| Secondary | Impact of Vaginal Pain Scores on Quality of Life Measures (ACTIVITY) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients "how is your vaginal pain impacting your ACTIVITY (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Posted | Median | Inter-Quartile Range | score on a scale | Subjects will be asked to provide numerical value on postoperative day 3. |
|
|
|
| Secondary | Impact of Vaginal Pain Scores on Quality of Life Measure (SLEEP) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients "how is your vaginal pain impacting your SLEEP (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Posted | Median | Inter-Quartile Range | score on a scale | Subjects will be asked to provide numerical value on postoperative day 3. |
|
|
|
| Secondary | Impact of Vaginal Pain Scores on Quality of Life Measure (MOOD) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients "how is your vaginal pain impacting your MOOD (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Posted | Median | Inter-Quartile Range | score on a scale | Subjects will be asked to provide numerical value on postoperative day 3. |
|
|
|
| Secondary | Impact of Vaginal Pain Scores on Quality of Life Measure (STRESS) Using Defense and Veterans Pain Rating Scale (Visual Analog Scale) Comparing the Bupivacaine Plus Exparel® Group and the Bupivacaine Plain Group | Investigators will ask patients "how is your vaginal pain impacting your STRESS (quality of life question)" and respond using a 0-10 answer (0 being no impact and 10 being significant impact) using the Defense and Veterans Pain Rating Scale (visual analog scale). This will be recorded on POD 3 | Posted | Median | Inter-Quartile Range | score on a scale | Subjects will be asked to provide numerical value on postoperative day 3. |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 3 |
| 60 |
| EG001 | Exparel Plus Plain Bupivacaine | 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed Exparel plus plain bupivacaine: 10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy | 0 | 60 | 0 | 60 | 4 | 60 |
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| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| vaginal |
|
| vaginal |
|