Back to resultsUse of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery
Primary Purpose
Stress Urinary Incontinence, Surgical Incision, Pain Vulva
Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine-Meloxicam
Sponsored by
About this trial
This is an interventional treatment trial for Stress Urinary Incontinence
Eligibility Criteria
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
Sites / Locations
- Cincinnati Urogynecology AssociatesRecruiting
- Trihealth (Good Samaritan Hospital, Bethesda North Hospital)Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
bupivacaine-meloxicam
Standard of Care
Arm Description
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
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.
Outcomes
Primary Outcome Measures
To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery
Pain medication diary
Secondary Outcome Measures
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05702827
Brief Title
Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery
Official Title
Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 23, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Urinary Incontinence, Surgical Incision, Pain Vulva
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
bupivacaine-meloxicam
Arm Type
Experimental
Arm Description
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
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-Meloxicam
Intervention Description
All patients will receive standard of care but the study arm will also receive Bupivacaine-Meloxicam in addition.
Primary Outcome Measure Information:
Title
To determine if use of bupivacaine-meloxicam reduces post-operative narcotic use over the first 3 days following surgery
Description
Pain medication diary
Time Frame
72 hours post surgery
Secondary Outcome Measure Information:
Title
Compare average pain on each day post operatively
Description
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
Time Frame
72 hours post surgery
Title
Compare worst pain on each day post operatively
Description
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
Time Frame
72 hours post surgery
Title
Compare satisfaction with pain control post operatively
Description
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
Time Frame
72 hours post surgery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mildrede Bonglack, MD
Phone
513-463-4300
Email
mildrede_bonglack@trihealth.com
Facility Information:
Facility Name
Cincinnati Urogynecology Associates
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Hodge, RN
Phone
513-463-4300
Email
Jennifer_Hodge2@trihealth.com
Facility Name
Trihealth (Good Samaritan Hospital, Bethesda North Hospital)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45220
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jenny Hodge
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of a Dual-agent Local Analgesic (Bupivacaine-meloxicam) for Abdominal Incisions in Patients Undergoing Retropubic Mid-urethral Sling Surgery
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