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

MetroHealth Medical Center1 site in 1 country72 target enrollmentAugust 1, 2019

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nerve Block
Sponsor: MetroHealth Medical Center
Enrollment: 72
Locations: 1
Primary Endpoint: Visual Analog Scores at 7am After Surgery
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

August 1, 2019

End Date

September 13, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

MetroHealth Medical Center

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Visual Analog Scores at 7am After Surgery

Time Frame: Postoperative day 1 at 7am

Visual analog score: 0 (No pain) - 100 (The worst imaginable pain)

Secondary Outcomes

Opioid Analgesic Use in the Post-anesthesia Care Unit(Through the time of discharge from the post-anesthesia care unit, on average 1-3 hours from the end of surgery.)
Visual Analog Scores at Discharge From Post-anesthesia Care Unit(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(96 hours postoperatively)
Quality of Recovery Scores on Post op Day 1 (7AM)(7am on postoperative day 1)
Satisfaction Scores in the Morning After Surgery (7AM)(7am on postoperative day 1)
Total Postoperative Opioid Use(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)
Satisfaction Scores 96 Hours After Surgery(96 hours postoperatively)
Severity of Postoperative Non-pain Symptoms(Postoperative day 1 (7AM))
Number of Participants With Postoperative Urinary Retention(Up to 96 hours after surgery)