Pudendal Nerve Block in Vaginal Surgery

MetroHealth Medical Center

Status: Completed

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

Treatments: Procedure: Pudendal block

Study type: Interventional

Funder types: Other

Identifiers

NCT04198714

IRB18-00759

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Pudendal block

Experimental group

Description:

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.

Treatment:

Procedure: Pudendal block

Placebo injection

Placebo Comparator group

Description:

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

Treatment:

Procedure: Pudendal block