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

Part of paid clinical trials in Bay Shore, New York.

Sponsor
Northwell Health
Study ID
NCT06379425
Phase
PHASE4
Status
Recruiting
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Conditions

  • Pain, Postoperative
  • Postoperative Pain, Acute

Eligibility Criteria

Sex
FEMALE
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Mar 1, 2024
Status verified
May 2025
Primary completion
Mar 1, 2026
Completion
Mar 1, 2026

Study Design

Enrollment
70 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION

Arms

  • Active Comparator: Standard of Care (SOC) (acetaminophen)
    one time dose of 1000mg acetaminophen orally
  • 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

Primary Outcome Measure

Time to initiation of active trial of void [ Time Frame: through study completion, an average of 2 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwell Health South Shore Surgery CenterBay ShoreNew York11706
Kathleen R Catalano, MSN, RN-BC
[email protected]
631-647-5550
Nirmala Pillalamarri, MD (PRINCIPAL_INVESTIGATOR)
Steliana Fakas, MD (SUB_INVESTIGATOR)

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