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

Sponsor

TriHealth Inc. (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05702827

Collaborator

(none)

126

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

3.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stress Urinary Incontinence Surgical Incision Pain Vulva	Drug: Bupivacaine-Meloxicam	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

126 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jun 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: bupivacaine-meloxicam All patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure. 3-4 cc of bupivacaine-meloxicam will be infiltrated into each suprapubic abdominal incision in the study group	Drug: Bupivacaine-Meloxicam All patients will receive standard of care but the study arm will also receive Bupivacaine-Meloxicam in addition.
No Intervention: Standard of Care All patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure.

Arm

Intervention/Treatment

Experimental: bupivacaine-meloxicam

All patients will receive a total of 20 cc lidocaine with epinephrine injection intra-operatively along the trocar path via the suprapubic incisions, as is standard practice to help with hydrodissection for the procedure. 3-4 cc of bupivacaine-meloxicam will be infiltrated into each suprapubic abdominal incision in the study group

Drug: Bupivacaine-Meloxicam

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

No Intervention: Standard of Care

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cincinnati Urogynecology Associates	Cincinnati	Ohio	United States	45220
2	Trihealth (Good Samaritan Hospital, Bethesda North Hospital)	Cincinnati	Ohio	United States	45220

Sponsors and Collaborators

TriHealth Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

TriHealth Inc.

ClinicalTrials.gov Identifier:

NCT05702827

Other Study ID Numbers:

22-102

First Posted:

Jan 27, 2023

Last Update Posted:

Jan 27, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Urinary Incontinence

Urinary Incontinence, Stress

Surgical Wound

Meloxicam

Bupivacaine

Study Results

No Results Posted as of Jan 27, 2023