Pudendal Nerve Block in Vaginal Surgery

Not Applicable

Completed

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

Interventions: Procedure: Pudendal block

Registration Number: NCT04198714

Lead Sponsor: MetroHealth Medical Center

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 72

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pudendal block	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.
Placebo injection	Pudendal block	10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side.

Primary Outcome Measures

Name	Time	Method
Visual Analog Scores at 7am After Surgery	Postoperative day 1 at 7am	Visual analog score: 0 (No pain) - 100 (The worst imaginable pain)

Secondary Outcome Measures

Name	Time	Method
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.	Total dose of opioids administered in the post-anesthesia care unit, in morphine equivalents.
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	Visual analog score: 0 (No pain) - 100 (The worst imaginable pain)
Pain Scores 96 Hours After Surgery	96 hours postoperatively	Numeric rating pain scale: 0 (No pain) - 100 (The worst imaginable pain)
Quality of Recovery Scores on Post op Day 1 (7AM)	7am on postoperative day 1	Quality of Recovery is a global measure of quality of recovery. It is scored from 40-200. A higher score = better recovery.
Satisfaction Scores in the Morning After Surgery (7AM)	7am on postoperative day 1	Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied)
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	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.
Satisfaction Scores 96 Hours After Surgery	96 hours postoperatively	Satisfaction with overall pain control: 0 (Not satisfied at all) - 100 (Extremely satisfied)
Severity of Postoperative Non-pain Symptoms	Postoperative day 1 (7AM)	Quality of Recovery Score, Part B "Comfort". Scale 8-40, higher score = better recovery
Number of Participants With Postoperative Urinary Retention	Up to 96 hours after surgery	Incidence of urinary retention