Pudendal Nerve Block in Vaginal Surgery

NCT04198714 | Completed Results DMC

• 1 other identifier: IRB18-00759
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scores at 7am After Surgery

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

  Postoperative day 1 at 7am

Secondary Outcomes (9)

• 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

• Pain Scores 96 Hours After Surgery

  96 hours postoperatively

• Quality of Recovery Scores on Post op Day 1 (7AM)

  7am on postoperative day 1

• Satisfaction Scores in the Morning After Surgery (7AM)

  7am on postoperative day 1

• Satisfaction Scores 96 Hours After Surgery

  96 hours postoperatively

Study Arms (2)

Pudendal block

EXPERIMENTAL

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.

Procedure: Pudendal block

Placebo injection

PLACEBO COMPARATOR

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

Procedure: Pudendal block

Interventions

Pudendal block PROCEDURE

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

Placebo injection; Pudendal block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Related Publications (2)

• Le Neveu M, Sears S, Rhodes S, Slopnick E, Petrikovets A, Mangel J, Sheyn D. The Impact of Pudendal Nerve Injection in Vaginal Surgery: A Secondary Analysis. Urogynecology (Phila). 2025 Sep 1;31(9):857-864. doi: 10.1097/SPV.0000000000001565.

  PMID: 39733282 DERIVED

• Slopnick EA, Sears SB, Chapman GC, Sheyn DD, Abrams MK, Roberts KM, Pollard R, Mangel J. Pudendal Nerve Block Analgesia at the Time of Vaginal Surgery: A Randomized, Double-Blinded, Sham-Controlled Trial. Urogynecology (Phila). 2023 Oct 1;29(10):827-835. doi: 10.1097/SPV.0000000000001351. Epub 2023 Apr 4.

  PMID: 37093572 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Pelvic Floor Disorders; Pelvic Organ Prolapse; Pudendal Neuralgia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Prolapse; Pathological Conditions, Anatomical; Nerve Compression Syndromes; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neuralgia

Results Point of Contact

• Title: Dr. Jeffrey Mangel
• Organization: MetroHealth Medical Center

jmangel@metrohealth.org

216-778-5595

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double-blind, placebo-controlled randomized controlled trial

Study Record Dates

• First Submitted: December 10, 2019
• First Posted: December 13, 2019
• Study Start: August 1, 2019
• Primary Completion: September 13, 2021
• Study Completion: September 13, 2021
• Last Updated: August 12, 2024
• Results First Posted: August 12, 2024

Record last verified: 2024-03

Locations

US (1)