Pudendal Nerve Block in Vaginal Surgery
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
- Nerve Block
- Pain, Postoperative
- Pelvic Floor Disorders
- Pelvic Organ Prolapse
- Pudendal Neuralgia
- Surgery
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
Arm | Description | Assigned 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. |
|
Sham Comparator Sham injection |
10cc normal saline. 5cc will be injected transvaginally in the area of the pudendal nerve on each side. |
|
More Details
- Status
- Active, not recruiting
- Sponsor
- MetroHealth Medical Center