Pudendal Nerve Block in Vaginal Surgery

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Pudendal Nerve Block Analgesia on Postoperative Pain Control in Patients Undergoing Vaginal Surgery: A Randomized Double-blind Placebo-controlled Trial

Conditions
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Nerve Block, Pain, Postoperative, Pelvic Floor Disorders, Pelvic Organ Prolapse, Pudendal Neuralgia, Surgery

Intervention / Treatment
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* Procedure: Pudendal block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consenting, English speaking women between ages 18 and 80 who will undergo vaginal surgery Ability to read VAS Scores Specific vaginal procedures include, but are not limited to: 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: History of chronic pelvic pain Currently taking sedatives Liver disease Renal disease Women who did not consent for the study. Intraoperative concern for increased blood loss Unable to speak English Unable to understand VAS Scores Undergoing concomitant abdominal or laparoscopic procedures Allergy to bupivacaine or triamcinolone Planned abdominal or laparoscopic procedures. Patients who are ineligible for non-narcotic pain medications, such as an allergy to acetaminophen or NSAIDs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blind, placebo-controlled randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pudendal block<br>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. | Procedure: Pudendal block<br>* Administration of a pudendal block at the conclusion of vaginal surgery.<br>|
| Sham Comparator: Sham injection<br>10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. | Procedure: Pudendal block<br>* Administration of a pudendal block at the conclusion of vaginal surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scores at 7am after surgery | Visual analog score: 0 (No pain) - 10 (The worst imaginable pain) | Postoperative day 1 at 7am | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scores at discharge from post-anesthesia care unit | Visual analog score: 0 (No pain) - 10 (The worst imaginable pain) | At the time of discharge from post-anesthesia care unit, on average 1-3 hours | 
| Pain Scores 96 hours after surgery | Numeric rating pain scale: 0 (No pain) - 10 (The worst imaginable pain) | 96 hours postoperatively | 
| Quality of Recovery scores on post op day 1 (7AM) | Quality of Recovery score: Part A 18 (very poor) - 90 (excellent); Part B 22 (excellent) - 110 (very poor) | 7am on postoperative day 1 | 
| Satisfaction scores in the morning after surgery (7AM) | Satisfaction with overall pain control: 0 (Not satisfied at all) - 10 (Extremely satisfied) | 7am on postoperative day 1 | 
| Satisfaction scores 96 hours after surgery | Satisfaction with overall pain control: 0 (Not satisfied at all) - 10 (Extremely satisfied) | 96 hours postoperatively | 
| Length of stay | Length of inpatient hospitalization after surgery | Through the time of hospital discharge, on average 15-20 hours | 
| 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 | 
| Total postoperative opioid use | Total dose of opioids administered during the first 24 hours after surgery, in morphine equivalents. | Through the time of hospital discharge, on average 15-20 hours | 
| Severity of postoperative non-pain symptoms | Quality of Recovery Score, Part B Comfort: 8 (none of the time) - 40 (All of the time) | Postoperative day 1 (7AM) | 
| Postoperative bladder function. | Incidence of urinary retention | Up to 96 hours after surgery | 
| Postoperative bowel function. | Time to first bowel movement | Up to 96 hours after surgery |