Pudendal Nerve Block in Vaginal Surgery

N/ACompletedNCT04198714

MetroHealth Medical Center72 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

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

Interventions

Pudendal blockPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

MetroHealth Medical Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Visual Analog Scores at 7am After Surgery

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

Time frame: Postoperative day 1 at 7am

Secondary Outcomes

Visual Analog Scores at Discharge From Post-anesthesia Care Unit

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

Time frame: 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)

Time frame: 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.

Time frame: 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)

Time frame: 7am on postoperative day 1

Satisfaction Scores 96 Hours After Surgery

Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied)

Time frame: 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.

Time frame: Through the time of discharge from the post-anesthesia care unit, on average 1-3 hours from the end of surgery.

Data from ClinicalTrials.gov

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