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NCT05702827 Clinical Trial

Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery

Stress Urinary Incontinence Clinical Trial

Official title:
Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05702827
Other study ID # 22-102
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date January 23, 2023
Est. completion date June 2024

Study information
Verified date May 2024
Source TriHealth Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 126
Est. completion date June 2024
Est. primary completion date March 22, 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Bupivacaine-Meloxicam
All patients will receive standard of care but the study arm will also receive Bupivacaine-Meloxicam in addition.

Locations
Country Name City State
United States Cincinnati Urogynecology Associates Cincinnati Ohio
United States Trihealth (Good Samaritan Hospital, Bethesda North Hospital) Cincinnati Ohio

Sponsors (1)
Lead Sponsor Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery Pain medication diary 72 hours post surgery
Secondary Compare average pain on each day post operatively 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 72 hours post surgery
Secondary Compare worst pain on each day post operatively 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 72 hours post surgery
Secondary Compare satisfaction with pain control post operatively 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 72 hours post surgery
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