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Non-opioid Analgesic

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

Phase 4

Recruiting

Research Sponsored by Northwell Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ability to take oral medication and be willing to adhere to the study intervention

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2 years

Awards & highlights

Study Summary

"This trial aims to see if taking a combination of acetaminophen, celecoxib, and gabapentin before surgery can help patients undergoing minor urogynecologic procedures to urinate quicker after

Who is the study for?

This trial is for patients scheduled for same-day minor urogynecologic surgeries who can take medications like acetaminophen, celecoxib, and gabapentin. Specific eligibility criteria are not provided.Check my eligibility

What is being tested?

The study tests if taking a combination of acetaminophen, celecoxib, and gabapentin before surgery helps patients recover bladder function faster than just acetaminophen alone. It's a randomized control trial with two groups.See study design

What are the potential side effects?

Possible side effects may include digestive issues from celecoxib or gabapentin, allergic reactions, dizziness or fatigue. Acetaminophen could cause liver damage if taken in high doses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can take pills and will follow the study's treatment plan.

Select...

I am a woman over 18, seeing a urogynecologist in Bay Shore, Syosset, or Huntington, NY for surgery like sling placement or pelvic repair.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to initiation of active trial of void

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Standard of Care (SOC) (acetaminophen) and investigational product (celecoxib + gabapentin)Experimental Treatment3 Interventions

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

Group II: Standard of Care (SOC) (acetaminophen)Active Control1 Intervention

one time dose of 1000mg acetaminophen orally

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Celecoxib

2019

Completed Phase 4

~1740

Gabapentin

2013

Completed Phase 4

~1550

Acetaminophen

2017

Completed Phase 4

~2030

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Northwell HealthLead Sponsor

460 Previous Clinical Trials

470,973 Total Patients Enrolled

4 Trials studying Postoperative Pain

372 Patients Enrolled for Postoperative Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of participants being recruited for this medical research study?

"Affirmative, the current information on clinicaltrials.gov indicates that patient recruitment is ongoing for this particular trial. This study was initially listed on March 1st, 2024, and its most recent update was made on April 17th, 2024. The research team aims to enroll a total of 70 participants from one designated site."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"According to clinicaltrials.gov, this study is presently seeking volunteers. Initially shared on 3/1/2024, the latest update was made on 4/17/2024."

Answered by AI

What is the risk level associated with Standard of Care (acetaminophen) and investigational product (celecoxib + gabapentin) for individuals?

"The safety assessment by the Power team ranks Standard of Care (acetaminophen) and the investigational product (celecoxib + gabapentin) at level 3. This ranking is due to this trial being classified as a Phase 4 study, indicating approval for use in treatments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2024. "Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06379425.

All > Acute Pain > Gabapentin