Pudendal Nerve Block in Vaginal Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Pelvic Organ Prolapse; Surgery; Pelvic Floor Disorders; Pudendal Neuralgia; Nerve Block
• Intervention / Treatment: Procedure: Pudendal block

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • MetroHealth Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

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) - 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	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

Collaborators and Investigators

• Sponsor: MetroHealth Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2019
• Primary Completion (Actual): September 13, 2021
• Study Completion (Actual): September 13, 2021

Study Registration Dates

• First Submitted: December 10, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): August 12, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Nerve Compression Syndromes; Pathological Conditions, Anatomical; Pregnancy Complications; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pain, Postoperative; Neuralgia; Prolapse; Pelvic Organ Prolapse; Pelvic Floor Disorders; Pudendal Neuralgia
• Other Study ID Numbers: IRB18-00759

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No