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NCT Number: NCT06379425

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Northwell Health South Shore Surgery Center

Bay Shore, New York, 11706, United States

Location status: Recruiting

Location contact

Kathleen R Catalano, MSN, RN-BC

CONTACT

[email protected]

631-647-5550

Nirmala Pillalamarri, MD

PRINCIPAL_INVESTIGATOR

Steliana Fakas, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)
  • Current use of illicit substances (cocaine, non-prescription opioids, marijuana)
  • Current use of gabapentin as home medication

Treatment and study plan

Acetaminophen

Drug

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

Celecoxib

Drug

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

Gabapentin

Drug

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

Primary outcomes

  1. Time to initiation of active trial of void

    Time frame: through study completion, an average of 2 years

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 23, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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