Pudendal Nerve Block in Vaginal Surgery

Surgery Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04198714
• Other study ID #: IRB18-00759
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2019
• Est. completion date: June 30, 2022

Study information

• Verified date: April 2022
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 72
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Pudendal block
Administration of a pudendal block at the conclusion of vaginal surgery.

Locations

Country	Name	City	State
United States	MetroHealth Medical Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analog Scores at 7am after surgery	Visual analog score: 0 (No pain) - 10 (The worst imaginable pain)	Postoperative day 1 at 7am
Secondary	Visual analog scores at discharge from post-anesthesia care unit	Visual analog score: 0 (No pain) - 10 (The worst imaginable pain)	At the time of discharge from post-anesthesia care unit, on average 1-3 hours
Secondary	Pain Scores 96 hours after surgery	Numeric rating pain scale: 0 (No pain) - 10 (The worst imaginable pain)	96 hours postoperatively
Secondary	Quality of Recovery scores on post op day 1 (7AM)	Quality of Recovery score: Part A 18 (very poor) - 90 (excellent); Part B 22 (excellent) - 110 (very poor)	7am on postoperative day 1
Secondary	Satisfaction scores in the morning after surgery (7AM)	Satisfaction with overall pain control: 0 (Not satisfied at all) - 10 (Extremely satisfied)	7am on postoperative day 1
Secondary	Satisfaction scores 96 hours after surgery	Satisfaction with overall pain control: 0 (Not satisfied at all) - 10 (Extremely satisfied)	96 hours postoperatively
Secondary	Length of stay	Length of inpatient hospitalization after surgery	Through the time of hospital discharge, on average 15-20 hours
Secondary	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
Secondary	Total postoperative opioid use	Total dose of opioids administered during the first 24 hours after surgery, in morphine equivalents.	Through the time of hospital discharge, on average 15-20 hours
Secondary	Severity of postoperative non-pain symptoms	Quality of Recovery Score, Part B "Comfort": 8 (none of the time) - 40 (All of the time)	Postoperative day 1 (7AM)
Secondary	Postoperative bladder function.	Incidence of urinary retention	Up to 96 hours after surgery
Secondary	Postoperative bowel function.	Time to first bowel movement	Up to 96 hours after surgery