RecruitingPhase 3NCT06039566

NAC vs Placebo on Opioid Use for Hysterectomy

A Trial Evaluating the Impact of N-acetylcysteine on Opioid Use in Patients Undergoing a Hysterectomy Procedure


Sponsor

Medical University of South Carolina

Enrollment

240 participants

Start Date

Nov 30, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria11

  • Inclusion
  • Undergoing elective laparoscopic or robotic, full, or partial hysterectomy procedure
  • years of age and older
  • Exclusion
  • Less than 40kg in weight
  • Unable to provide written, informed consent
  • History of an adverse or anaphylactoid reaction to acetylcysteine
  • Active asthma, wheezing, or using inhaled bronchodilators
  • Non-English speaking
  • Insulin dependent diabetes if D5W is required
  • Blood clotting disorders

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Interventions

DRUGIV N-acetylcysteine

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

DRUGIV Placebo

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.


Locations(1)

Medical University of South Carolina

Charleston, South Carolina, United States

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NCT06039566


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