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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Healthy Volunteers: t
View:

• 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

Locations
United States
New York
Northwell Health South Shore Surgery Center
RECRUITING
Bay Shore
Time Frame
Start Date: 2024-03-01
Estimated Completion Date: 2026-03-01
Participants
Target number of participants: 70
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Northwell Health

This content was sourced from clinicaltrials.gov

Similar Clinical Trials