Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this this randomized controlled study is to determine whether a pudendal nerve block at the time of vaginal surgery is associated with improved postoperative pain control and decrease opioid consumption compared to a sham pudendal nerve block in patients undergoing vaginal surgery.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pudendal block | Experimental | 9cc of 0.25% Marcaine + 1cc of 40mg/mL triamcinolone. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. |
|
| Placebo injection | Placebo Comparator | 10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pudendal block | Procedure | Administration of a pudendal block at the conclusion of vaginal surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scores at 7am After Surgery | Visual analog score: 0 (No pain) - 100 (The worst imaginable pain) | Postoperative day 1 at 7am |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analog Scores at Discharge From Post-anesthesia Care Unit | Visual analog score: 0 (No pain) - 100 (The worst imaginable pain) | At the time of discharge from post-anesthesia care unit, on average 1-3 hours from end of surgery |
| Pain Scores 96 Hours After Surgery |
Not provided
Inclusion Criteria:
Perineoplasty Complete vaginectomy Le Forte colpocleisis Anterior repair, posterior repair, and/or enterocele repair Transvaginal mesh use Transvaginal mesh excision Sacrospinous ligament fixation Uterosacral ligament suspension Vaginal paravaginal defect repair Midurethral sling placement Sphincteroplasty Vaginal hysterectomy, with or without removal of tube(s) and/or ovary(s), with or without repair of enterocele
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39733282 | Derived | Le Neveu M, Sears S, Rhodes S, Slopnick E, Petrikovets A, Mangel J, Sheyn D. The Impact of Pudendal Nerve Injection in Vaginal Surgery: A Secondary Analysis. Urogynecology (Phila). 2025 Sep 1;31(9):857-864. doi: 10.1097/SPV.0000000000001565. | |
| 37093572 | Derived | Slopnick EA, Sears SB, Chapman GC, Sheyn DD, Abrams MK, Roberts KM, Pollard R, Mangel J. Pudendal Nerve Block Analgesia at the Time of Vaginal Surgery: A Randomized, Double-Blinded, Sham-Controlled Trial. Urogynecology (Phila). 2023 Oct 1;29(10):827-835. doi: 10.1097/SPV.0000000000001351. Epub 2023 Apr 4. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Pudendal Block | 9cc of 0.25% Marcaine + 1cc of 40mg/mL triamcinolone. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. Pudendal block: Administration of a pudendal block at the conclusion of vaginal surgery. |
| FG001 | Placebo Injection | 10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. Pudendal block: Administration of a pudendal block at the conclusion of vaginal surgery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Pudendal Block | Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side |
| BG001 | Placebo Injection | Placebo arm, received 10cc normal saline 5cc injected on each side |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Visual Analog Scores at 7am After Surgery | Visual analog score: 0 (No pain) - 100 (The worst imaginable pain) | Posted | Median | Standard Deviation | score on a scale | Postoperative day 1 at 7am |
|
|
Through postop day 4
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pudendal Block | Medication arm, received 9cc 0.5% bupivacaine + 1cc 40mg/cc triamcinolone 5 cc injected on each side |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeffrey Mangel | MetroHealth Medical Center | 216-778-5595 | jmangel@metrohealth.org |
Not provided
| 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 | Jan 5, 2021 | Aug 12, 2022 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059952 | Pelvic Floor Disorders |
| D056887 | Pelvic Organ Prolapse |
| D060545 | Pudendal Neuralgia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
Not provided
Not provided
Double-blind, placebo-controlled randomized controlled trial
Not provided
Not provided
Not provided
Numeric rating pain scale: 0 (No pain) - 100 (The worst imaginable pain) |
| 96 hours postoperatively |
| Quality of Recovery Scores on Post op Day 1 (7AM) | Quality of Recovery is a global measure of quality of recovery. It is scored from 40-200. A higher score = better recovery. | 7am on postoperative day 1 |
| Satisfaction Scores in the Morning After Surgery (7AM) | Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied) | 7am on postoperative day 1 |
| Satisfaction Scores 96 Hours After Surgery | Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied) | 96 hours postoperatively |
| Opioid Analgesic Use in the Post-anesthesia Care Unit | Total dose of opioids administered in the post-anesthesia care unit, in morphine equivalents. | Through the time of discharge from the post-anesthesia care unit, on average 1-3 hours from the end of surgery. |
| Total Postoperative Opioid Use | Total dose of opioids administered (in morphine equivalents) from time of arrival to the post-anesthesia care unit until either they were discharged from the hospital on POD#1 up to 24 hours postop OR if they were discharged on POD#0, the end timepoint was the time of the phone call on POD#1, up to 24 hours after surgery. | From the time a patient arrived in the post-anesthesia recovery unit until discharged from the hospital up to 24 hours OR time of their POD#1 phone call if discharged on same day as surgery up to 24 hours |
| Severity of Postoperative Non-pain Symptoms | Quality of Recovery Score, Part B "Comfort". Scale 8-40, higher score = better recovery | Postoperative day 1 (7AM) |
| Number of Participants With Postoperative Urinary Retention | Incidence of urinary retention | Up to 96 hours after surgery |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Obesity | Count of Participants | Participants |
|
| Tobacco use | Count of Participants | Participants |
|
| Chronic pain | Count of Participants | Participants |
|
| Preoperative diagnosis | Count of Participants | Participants |
|
| Surgery performed | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Visual Analog Scores at Discharge From Post-anesthesia Care Unit | Visual analog score: 0 (No pain) - 100 (The worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | At the time of discharge from post-anesthesia care unit, on average 1-3 hours from end of surgery |
|
|
|
| Secondary | Pain Scores 96 Hours After Surgery | Numeric rating pain scale: 0 (No pain) - 100 (The worst imaginable pain) | Posted | Mean | Standard Deviation | score on a scale | 96 hours postoperatively |
|
|
|
| Secondary | Quality of Recovery Scores on Post op Day 1 (7AM) | Quality of Recovery is a global measure of quality of recovery. It is scored from 40-200. A higher score = better recovery. | Posted | Mean | Standard Deviation | score on a scale | 7am on postoperative day 1 |
|
|
|
| Secondary | Satisfaction Scores in the Morning After Surgery (7AM) | Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied) | Posted | Mean | Standard Deviation | score on a scale | 7am on postoperative day 1 |
|
|
|
| Secondary | Satisfaction Scores 96 Hours After Surgery | Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied) | Posted | Mean | Standard Deviation | score on a scale | 96 hours postoperatively |
|
|
|
| Secondary | Opioid Analgesic Use in the Post-anesthesia Care Unit | Total dose of opioids administered in the post-anesthesia care unit, in morphine equivalents. | Posted | Median | Standard Deviation | morphine milligram equivalents | Through the time of discharge from the post-anesthesia care unit, on average 1-3 hours from the end of surgery. |
|
|
|
| Secondary | Total Postoperative Opioid Use | Total dose of opioids administered (in morphine equivalents) from time of arrival to the post-anesthesia care unit until either they were discharged from the hospital on POD#1 up to 24 hours postop OR if they were discharged on POD#0, the end timepoint was the time of the phone call on POD#1, up to 24 hours after surgery. | Posted | Median | Standard Deviation | morphine milligram equivalents | From the time a patient arrived in the post-anesthesia recovery unit until discharged from the hospital up to 24 hours OR time of their POD#1 phone call if discharged on same day as surgery up to 24 hours |
|
|
|
| Secondary | Severity of Postoperative Non-pain Symptoms | Quality of Recovery Score, Part B "Comfort". Scale 8-40, higher score = better recovery | Posted | Mean | Standard Deviation | score on a scale | Postoperative day 1 (7AM) |
|
|
|
| Secondary | Number of Participants With Postoperative Urinary Retention | Incidence of urinary retention | Posted | Count of Participants | Participants | Up to 96 hours after surgery |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 0 |
| 36 |
| EG001 | Placebo Injection | Placebo arm, received 10cc normal saline 5cc injected on each side | 0 | 36 | 0 | 36 | 0 | 36 |
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
| D052801 | Male Urogenital Diseases |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D009408 | Nerve Compression Syndromes |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009437 | Neuralgia |