Pain, PostoperativePhase 4NCT06379425
Impact of Preoperative Opioid-free Multimodal Analgesia on Time to Trial of Void in Ambulatory Urogynecologic Surgeries
A Phase 4 study testing Acetaminophen, Celecoxib and Gabapentin in people with Pain, Postoperative and Postoperative Pain, Acute, run by Northwell Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Postoperative Pain, Acute
- What is being tested?
- Acetaminophen, Celecoxib and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 1 Mar 2027
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Northwell Health South Shore Surgery Center
Bay Shore, New York, 11706
Kathleen R Catalano, MSN, RN-BC, 631-647-5550, kcatalano@southshoresurg.com
Nirmala Pillalamarri, MD
About this study
Official title: 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.
- Conditions
- Pain, Postoperative, Postoperative Pain, Acute
- Being tested
- Acetaminophen, Celecoxib, Gabapentin
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
CelecoxibDrug
Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
GabapentinDrug
Will add additional medications celecoxib and gabapentin to acetaminophen preoperatively prior to patient surgery
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (SOC) (acetaminophen) | Active comparator | one time dose of 1000mg acetaminophen orally Receives: 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 Receives: Drug: Acetaminophen; Drug: Celecoxib; Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to initiation of active trial of void
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start1 Mar 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379425
- Sponsor's protocol ID
- 23-0050
- Status last verified
- Oct 2026
- First submitted
- 3 Apr 2024
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No