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NAC Vs Placebo on Opioid Use for Hysterectomy

Phase 3
Recruiting
Conditions
Hysterectomy
Interventions
Registration Number
NCT06039566
Lead Sponsor
Medical University of South Carolina
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
240
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
IV PlaceboIV PlaceboPatients 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.
IV N-acetylcysteineIV N-acetylcysteinePatients 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 Measures
NameTimeMethod
Opioid Consumption 0-72 hours post-study medication0-72 hours after study medication

72-hour post-medication opioid consumption.

Secondary Outcome Measures
NameTimeMethod
Pain ScoresStudy medication start to 72 hours post-study medication

Using a Visual Analog Scale from 0-100, patients will report pain scores from 0-72 hours post-medication. A lower pain score means a better outcome.

Trial Locations

Locations (1)

Medical University of South Carolina

🇺🇸

Charleston, South Carolina, United States

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