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NCT Number: NCT05702827

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

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.

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Key information

Conditions

Stress Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Lower Urinary Tract Symptoms Male Urogenital Diseases Pain Vulva Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgical Incision Surgical Wound Urinary Incontinence Urinary Incontinence, Stress Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations Vulvar Diseases Vulvodynia Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Cincinnati Urogynecology Associates, Cincinnati, Ohio, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine-Meloxicam

Drug

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

Primary outcomes

  1. To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery

    Time frame: 72 hours post surgery

    Pain medication diary

Secondary outcomes

  1. Compare average pain on each day post operatively

    Time frame: 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

  2. Compare worst pain on each day post operatively

    Time frame: 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

  3. Compare satisfaction with pain control post operatively

    Time frame: 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

Sponsors and collaborators

Lead sponsor

TriHealth Inc.

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 27, 2023
Registry last updated
Nov 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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