Actively Recruiting
Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries: A Randomized Controlled Trial
Led by Northwell Health · Updated on 2025-05-22
70
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effect of preoperative opioid-free pain relief on the time it takes for patients to resume normal bladder function after same-day minor urogynecologic surgeries. This randomized controlled trial compares two groups: one receiving acetaminophen alone and the other receiving a combination of acetaminophen, celecoxib, and gabapentin before surgery. The goal is to see if the combination reduces the time to trial of void in female patients undergoing these procedures. Participants are randomly assigned to receive either a single oral dose of 1000 mg acetaminophen alone or a combination of 1000 mg acetaminophen, 400 mg celecoxib, and 300 mg gabapentin before their urogynecologic surgery. These surgeries include procedures such as midurethral sling, periurethral bulking injections, anterior repair, posterior repair, and perineorrhaphy. The study period lasts for about two years to complete the follow-up. During the study, researchers will monitor the time until participants begin an active trial of void following surgery. Participants must be female, over 18 years of age, and in good general health to take oral medications. They will be assessed for safety and adherence to the study treatment. The primary outcome measure is the time to initiation of active trial of void, tracked through study completion. This study is sponsored by Northwell Health and includes regular monitoring without masking or blinding.
CONDITIONS
Brief Title
Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and be available for the study duration
- Female patients over 18 years old undergoing transvaginal minor urogynecologic surgery at specified Northwell Health centers
- In good general health based on medical history
- Able to take oral medication and willing to follow the study treatment
- English or Spanish speaking and able to provide informed consent
You will not qualify if you...
- Pregnancy or lactation
- Younger than 18 years
- Known allergies to acetaminophen, celecoxib, gabapentin, or any components of these medications
- Medical conditions including Myasthenia Gravis, renal disease with CrCl < 50, seizure disorder, substance use disorder, anaphylaxis or angioedema to gabapentin, DRESS, driving impairment, increased seizures, suicidal behavior, or respiratory depression
- History of asthma, urticaria, or allergic reactions to aspirin or NSAIDs, gastric bypass surgery, heart failure, active GI ulcer or bleeding, inflammatory bowel disease, cerebrovascular bleeding, liver impairment, or hyperkalemia
- Compromised renal function preventing NSAID use
- Significant cardiovascular disease such as heart failure
- Recent worsening fluid retention
- Non-English and non-Spanish speaking patients
- Urogynecologic surgeries for apical repair (e.g., sacrocolpopexy)
- Current use of illicit substances (cocaine, non-prescription opioids, marijuana)
- Current use of gabapentin as a home medication
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - One day (preoperative period)
Participants receive a one-time preoperative dose of acetaminophen alone or acetaminophen combined with celecoxib and gabapentin before their ambulatory urogynecologic surgery.
1 visit (in-person)
Duration - Through study completion, an average of 2 years
Participants are monitored post-surgery to measure the time to initiation of the active trial of void and recovery progress.
Follow-up visits as per clinical care
Trial Site Locations
Total: 1 location
1
Northwell Health South Shore Surgery Center
Bay Shore, New York, United States, 11706
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
PREVENTION
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here