NAC vs Placebo on Opioid Use for Hysterectomy

Part of paid clinical trials in Charleston, South Carolina.

Sponsor
Medical University of South Carolina
Study ID
NCT06039566
Phase
PHASE3
Status
Recruiting
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Conditions

  • Hysterectomy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IV N-acetylcysteine — DRUG
    N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure
  • IV Placebo — DRUG
    Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.

Study Details

This study will enroll females who are ages 18 and older undergoing a laparoscopic or robotic, partial or full hysterectomy. Participants will be randomized to receive IV n-acetylcysteine or placebo during the first 60 minutes of their procedure. At various time points after the procedure patients will be asked to report their pain scores, and any pain medication taken.

Key Dates

Start date
Nov 30, 2023
Status verified
Oct 2025
Primary completion
Nov 25, 2026
Completion
Dec 9, 2026

Study Design

Enrollment
240 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: IV Placebo
    Patients will receive: Placebo 0 mg/kg (placebo: 0.45% NaCl or D5W) through an IV that will run for 60 minutes at the start of the procedure.
  • Active Comparator: IV N-acetylcysteine
    Patients will receive: N-acetylcysteine (NAC) 150 mg/kg (Max dose 15,000 mg) through an IV that will run for 60 minutes at the start of the procedure.

Primary Outcome Measure

Opioid Consumption 0-72 hours post-study medication [ Time Frame: 0-72 hours after study medication ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Medical University of South CarolinaCharlestonSouth Carolina29425
Sylvia Wilson, MD
[email protected]
843-792-2322
Sylvia Wilson, MD (PRINCIPAL_INVESTIGATOR)

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Medical University of South Carolina· Charleston, SC

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