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

NCT06379425 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: 23-0050
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to initiation of active trial of void

  through study completion, an average of 2 years

Study Arms (2)

Standard of Care (SOC) (acetaminophen)

ACTIVE COMPARATOR

one time dose of 1000mg acetaminophen orally

Drug: Acetaminophen

Standard of Care (SOC) (acetaminophen) and investigational product (celecoxib + gabapentin)

EXPERIMENTAL

one time dose of 1000mg acetaminophen orally combined with 400mg celecoxib orally, and 300mg gabapentin orally

Drug: Acetaminophen; Drug: Celecoxib; Drug: Gabapentin

Interventions

Acetaminophen DRUG

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

Standard of Care (SOC) (acetaminophen); Standard of Care (SOC) (acetaminophen) and investigational product (celecoxib + gabapentin)

Celecoxib 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)

Gabapentin 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)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwell Health: lead

Study Sites (1)

Northwell Health South Shore Surgery Center

Bay Shore, New York, 11706, United States

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetaminophen; Celecoxib; Gabapentin

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzenesulfonamides; Sulfonamides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2024
• First Posted: April 23, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

US (1)