Stress Urinary Incontinence, Surgical Incision, Pain Vulva
Conditions
Brief summary
This study will compare the use of a dual-agent local analgesic (bupivacaine-meloxicam) for abdominal incisions in patients undergoing retropubic mid-urethral sling surgery to see if narcotic usage and pain are impacted.
Interventions
All patients will receive standard of care but the study arm will also receive Bupivacaine-Meloxicam in addition.
Sponsors
TriHealth Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* undergoing retropubic mid-urethral sling surgery (with concomitant anterior repair or urethrocele repair) * English as first language
Exclusion criteria
* patients undergoing concomitant posterior repair, vaginal vault suspension, or any other intra-peritoneal surgeries including hysterectomy * NSAID use within 7 days of surgery * steroid use within 10 days * daily opioid use in the last 3 months * long acting opioids within 3 days * any opioids within 24h * patients unable to consent for themselves * patients allergic to meloxicam or bupivacaine * pregnant or lactating patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery | 72 hours post surgery | Pain medication diary |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare average pain on each day post operatively | 72 hours post surgery | 11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3 |
| Compare worst pain on each day post operatively | 72 hours post surgery | 11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3 |
| Compare satisfaction with pain control post operatively | 72 hours post surgery | 11-point Numeric Rating Scale (NRS) for tracking pain using an illustrated figure to localize the pain, a 5-point Likert scale for satisfaction with pain control a Quality of Recovery (QoR-15) questionnaire filled out before surgery and on post-operative days 1 and 3 |
Countries
United States
Outcome results
None listed