Recruiting

Opioid-free Analgesia

Sponsor:

Northwell Health

Code:

NCT06379425

Conditions

Pain, Postoperative

Postoperative Pain, Acute

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

Interventions

Acetaminophen

Celecoxib

Gabapentin

Study Details

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.

Conditions

Pain, Postoperative

Postoperative Pain, Acute

Study ID

NCT06379425

Start date

Mar 1, 2024

Status verified date

May, 2025

Completion date

Mar 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

active comparator: Standard of Care (SOC) (acetaminophen)

one time dose of 1000mg acetaminophen orally

experimental: Standard of Care (SOC) (acetaminophen) and investigational product (celecoxib + gabapentin)

one time dose of 1000mg acetaminophen orally combined with 400mg celecoxib orally, and 300mg gabapentin orally

Interventions

Acetaminophen

Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery

Celecoxib

Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery

Gabapentin

Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery

Primary outcome measure

  • Time to initiation of active trial of void [ Time Frame: through study completion, an average of 2 years ]

Central Contacts and Locations

Locations

Northwell Health South Shore Surgery Center

Recruiting

Bay Shore, New York, United States, 11706

Contacts

Kathleen R Catalano, MSN, RN-BC

631-647-5550kcatalano@southshoresurg.com

Principal Investigator:

Nirmala Pillalamarri, MD

More Information

Sponsor

Northwell Health

Last update posted

May 22, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Northwell Health on 2025-05-22.