Pudendal Nerve Block in Vaginal Surgery
Nerve Block · Pain, Postoperative · Pelvic Floor Disorders · Pelvic Organ Prolapse · Pudendal Neuralgia
Bottom Line
View on ClinicalTrials.gov: NCT04198714 ↗Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pudendal block (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- MetroHealth Medical Center
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scores at 7am After Surgery |
29.2; 42.6 | — |
| SECONDARY Visual Analog Scores at Discharge From Post-anesthesia Care Unit |
53.1; 56.4 | — |
| SECONDARY Pain Scores 96 Hours After Surgery |
26.7; 35.5 | — |
| SECONDARY Quality of Recovery Scores on Post op Day 1 (7AM) |
177.7; 172.3 | — |
| SECONDARY Satisfaction Scores in the Morning After Surgery (7AM) |
81.5; 79.6 | — |
| SECONDARY Satisfaction Scores 96 Hours After Surgery |
80.5; 79.4 | — |
| SECONDARY Opioid Analgesic Use in the Post-anesthesia Care Unit |
5; 7.8 | — |
| SECONDARY Total Postoperative Opioid Use |
15; 20.5 | — |
| SECONDARY Severity of Postoperative Non-pain Symptoms |
37.2; 35.3 | — |
| SECONDARY Number of Participants With Postoperative Urinary Retention |
7; 4 | — |
Summary
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04198714). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.