Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Genders
Female
Accepts Healthy Volunteers
Yes

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Double-blind, placebo-controlled randomized controlled trial
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Procedure: Pudendal block
    Administration of a pudendal block at the conclusion of vaginal surgery.
Sham Comparator
Sham injection
10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side.
  • Procedure: Pudendal block
    Administration of a pudendal block at the conclusion of vaginal surgery.

Recruiting Locations

MetroHealth Medical Center
Cleveland, Ohio 44109
Contact:
Jeffrey Mangel, MD
440-778-4444
jmangel@metrohealth.org

More Details

Status
Recruiting
Sponsor
MetroHealth Medical Center

Study Contact

Jeffrey Mangel, MD
(216) 778-4444
jmangel@metrohealth.org

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.