Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries

NCT ID: NCT06379425

Last Updated: 2025-05-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2026-03-01

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Standard of Care (SOC) (acetaminophen)

one time dose of 1000mg acetaminophen orally

Group Type: ACTIVE_COMPARATOR

Acetaminophen

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Acetaminophen

Intervention Type: DRUG

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

Celecoxib

Intervention Type: DRUG

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

Gabapentin

Intervention Type: DRUG

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

Interventions

Acetaminophen

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

Intervention Type: DRUG

Celecoxib

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

Intervention Type: DRUG

Gabapentin

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

Intervention Type: DRUG

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Northwell Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Northwell Health South Shore Surgery Center

Bay Shore, New York, United States

Site Status: RECRUITING

Countries

United States

Facility Contacts

Kathleen R Catalano, MSN, RN-BC

Role: primary

kcatalano@southshoresurg.com

631-647-5550

Other Identifiers

23-0050

Identifier Type: -

Identifier Source: org_study_id