Clinical trial NCT04198714: Pudendal Nerve Block in Vaginal Surgery
Official title: The Effect of Pudendal Nerve Block Analgesia on Postoperative Pain Control in Patients Undergoing Vaginal Surgery: A Randomized Double-blind Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nerve Block
Pain, Postoperative
Pelvic Floor Disorders
Pelvic Organ Prolapse
Pudendal Neuralgia
Surgery
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2019-12-13
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, placebo-controlled randomized controlled trial
Primary purpose: TREATMENT

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.


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
* Planned abdominal or laparoscopic procedures.
* Patients who are ineligible for non-narcotic pain medications, such as an allergy to acetaminophen or NSAIDs

Primary outcomes:
measure: Visual Analog Scores at 7am After Surgery
timeFrame: Postoperative day 1 at 7am
Secondary outcomes:
measure: Visual Analog Scores at Discharge From Post-anesthesia Care Unit
timeFrame: At the time of discharge from post-anesthesia care unit, on average 1-3 hours from end of surgery
measure: Pain Scores 96 Hours After Surgery
timeFrame: 96 hours postoperatively
measure: Quality of Recovery Scores on Post op Day 1 (7AM)
timeFrame: 7am on postoperative day 1
measure: Satisfaction Scores in the Morning After Surgery (7AM)
timeFrame: 7am on postoperative day 1
measure: Satisfaction Scores 96 Hours After Surgery
timeFrame: 96 hours postoperatively
measure: Opioid Analgesic Use in the Post-anesthesia Care Unit
timeFrame: Through the time of discharge from the post-anesthesia care unit, on average 1-3 hours from the end of surgery.
measure: Total Postoperative Opioid Use
timeFrame: 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
measure: Severity of Postoperative Non-pain Symptoms
timeFrame: Postoperative day 1 (7AM)
measure: Number of Participants With Postoperative Urinary Retention
timeFrame: Up to 96 hours after surgery
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
Study officials:
References: