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

Northwell Health1 site in 1 country70 target enrollmentMarch 1, 2024

ConditionsPain, Postoperative Postoperative Pain, Acute

InterventionsAcetaminophen Celecoxib Gabapentin

DrugsAcetaminophen Celecoxib Gabapentin

Overview

Phase: Phase 4
Intervention: Acetaminophen
Conditions: Pain, Postoperative
Sponsor: Northwell Health
Enrollment: 70
Locations: 1
Primary Endpoint: Time to initiation of active trial of void
Status: Recruiting
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 1, 2024

End Date

March 1, 2026

Last Updated

11 months ago

Study Type

Interventional

Study Design

Crossover

Sex

Female

Investigators

Sponsor

Northwell Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provision of signed and dated informed consent form
•Stated willingness to comply with all study procedures and availability for the duration of the study
•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
•In good general health as evidenced by medical history
•Ability to take oral medication and be willing to adhere to the study intervention
•Patients may be English or Spanish-speaking and must be able to provide informed consent

Exclusion Criteria

•Pregnancy or lactation
•Younger than age 18
•Known allergic reactions to acetaminophen, celecoxib or gabapentin or any components within the medication formulation
•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.
•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.
•Patients with compromised renal function who are notable to receive NSAIDs
•Patients with significant cardiovascular disease, such as patients with heart failure
•Patient with recent evidence of worsening fluid retention
•Both non-English and non-Spanish speaking patients
•Urogynecologic surgeries for apical repair (sacrocolpopexy, uterosacral ligament suspension, sacrospinous ligament suspension, colpocleisis)