Pudendal Nerve Block in Vaginal Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-01

Study Completion Date

2021-09-13

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.

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Double-blind, placebo-controlled randomized controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Pudendal block

Intervention Type PROCEDURE

Administration of a pudendal block at the conclusion of vaginal surgery.

Placebo injection

10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side.

Group Type PLACEBO_COMPARATOR

Pudendal block

Intervention Type PROCEDURE

Administration of a pudendal block at the conclusion of vaginal surgery.

Interventions

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Pudendal block

Administration of a pudendal block at the conclusion of vaginal surgery.

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes