NCT06379425 Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries
| NCT ID | NCT06379425 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Northwell Health |
| Condition | Pain, Postoperative |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2024-03-01 |
| Primary Completion | 2026-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 70 participants in total. It began in 2024-03-01 with a primary completion date of 2026-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a double-arm randomized control trial evaluating the impact of preoperative opioid-free analgesia on time to trial of void in ambulatory urogynecologic surgeries. The investigators hypothesize that receipt of acetaminophen, celecoxib and gabapentin preoperatively versus acetaminophen alone will reduce the time to trial of void in patients undergoing same-day minor urogynecologic procedures.
Eligibility 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
Frequently Asked Questions
Who can join the NCT06379425 clinical trial?
This trial is open to female participants only, studying Pain, Postoperative. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06379425 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06379425 currently recruiting?
Yes, NCT06379425 is actively recruiting participants. Visit ClinicalTrials.gov or contact Northwell Health to inquire about joining.
Where is the NCT06379425 trial being conducted?
This trial is being conducted at Bay Shore, United States.
Who is sponsoring the NCT06379425 clinical trial?
NCT06379425 is sponsored by Northwell Health. The trial plans to enroll 70 participants.