Evaluating opioid-free pain management before urogynecologic surgeries
Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries: A Randomized Controlled Trial
This study is testing if a combination of pain relievers without opioids can help women recover faster after certain bladder surgeries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Sex | Female |
| Sponsor | Northwell Health Academic / other |
| Locations | 1 site (Bay Shore, New York) |
| Trial ID | NCT06379425 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a double-arm randomized control study that investigates the effects of preoperative opioid-free analgesia on the time to trial of void in patients undergoing ambulatory urogynecologic surgeries. Participants will receive either a combination of acetaminophen, celecoxib, and gabapentin or acetaminophen alone before their procedures. The goal is to determine if the multimodal approach can enhance recovery and reduce the time to trial of void after surgery. The study focuses on female patients over 18 years old who are in good general health and undergoing specific minor urogynecologic surgeries.
Who should consider this trial
Good fit: Ideal candidates are female patients over 18 years old in good health, undergoing specific minor urogynecologic surgeries at Northwell Health.
Not a fit: Patients who are pregnant, lactating, or have known allergies to the study medications will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to faster recovery times and improved postoperative pain management for patients undergoing urogynecologic surgeries.
How similar studies have performed: Other studies have shown promising results with multimodal analgesia approaches, suggesting potential success for this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. All female patients over 18 years of age from the Northwell Health urogynecology offices in Bay Shore, Syosset, and Huntington, NY who are undergoing transvaginal minor urogynecologic surgery (midurethral sling, periurethral bulking injections, anterior repair, posterior repair, and perineorrhaphy) at South Shore Surgery Center 4. In good general health as evidenced by medical history 5. Ability to take oral medication and be willing to adhere to the study intervention 6. Patients may be English or Spanish-speaking and must be able to provide informed consent Exclusion Criteria: 1. Pregnancy or lactation 2. Younger than age 18 3. Known allergic reactions to acetaminophen, celecoxib or gabapentin or any components within the medication formulation 4. Patients with Myasthenia Gravis, renal disease with CrCl \< 50, seizure disorder, substance use disorder, anaphylaxis and angioedema to gabapentin, Drug reaction with Eosinophilia and Systemic Symptoms (DRESS), driving impairment, increased seizures suicidal behavior and respiratory depression. 5. Patients with a , history of asthma, urticaria, or other allergic type reactions after taking aspirin or other NSAIDS or DRESS, history of gastric bypass surgery, heart failure, active GI ulcer, active GI bleeding, inflammatory bowel disease, cerebrovascular bleeding, liver impairment/hepatic disease, hyperkalemia. 6. Patients with compromised renal function who are notable to receive NSAIDs 7. Patients with significant cardiovascular disease, such as patients with heart failure 8. Patient with recent evidence of worsening fluid retention 9. Both non-English and non-Spanish speaking patients 10. Urogynecologic surgeries for apical repair (sacrocolpopexy, uterosacral ligament suspension, sacrospinous ligament suspension, colpocleisis) 11. Current use of illicit substances (cocaine, non-prescription opioids, marijuana) 12. Current use of gabapentin as home medication
Where this trial is running
Bay Shore, New York
- Northwell Health South Shore Surgery Center — Bay Shore, New York, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.