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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Postoperative Pain, Acute
• Intervention / Treatment: Drug: Acetaminophen; Drug: Celecoxib; Drug: Gabapentin

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • Bay Shore, New York, United States, 11706
      • Recruiting
      • Northwell Health South Shore Surgery Center
      • Contact: Kathleen R Catalano, MSN, RN-BC; Phone Number: 631-647-5550; Email: kcatalano@southshoresurg.com
      • Principal Investigator: Nirmala Pillalamarri, MD
      • Sub-Investigator: Steliana Fakas, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Standard of Care (SOC) (acetaminophen); one time dose of 1000mg acetaminophen orally	Drug: Acetaminophen; Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
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	Drug: Acetaminophen; Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery; Drug: Celecoxib; Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery; Drug: Gabapentin; Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to initiation of active trial of void	through study completion, an average of 2 years

Collaborators and Investigators

• Sponsor: Northwell Health

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: April 3, 2024
• First Submitted That Met QC Criteria: April 17, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Neurotransmitter Agents; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Anti-Anxiety Agents; Tranquilizing Agents; Psychotropic Drugs; Anticonvulsants; Antimanic Agents; Excitatory Amino Acid Agents; Excitatory Amino Acid Antagonists; Cyclooxygenase 2 Inhibitors; Gabapentin; Celecoxib; Acetaminophen
• Other Study ID Numbers: 23-0050

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No