NAC vs Placebo on Opioid Use for Hysterectomy

Medical University of South Carolina (MUSC)

Status and phase: Enrolling; Phase 3

Conditions: Hysterectomy

Treatments: Drug: IV Placebo; Drug: IV N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT06039566

Pro00130489

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion

• Undergoing elective laparoscopic or robotic, full, or partial hysterectomy procedure
• 18 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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240 participants in 2 patient groups, including a placebo group

IV Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: IV Placebo

IV N-acetylcysteine

Active Comparator group

Description:

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.

Treatment:

Drug: IV N-acetylcysteine