NAC vs Placebo on Opioid Use for Hysterectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-30

Study Completion Date

2026-12-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Hysterectomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

IV Placebo

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

IV N-acetylcysteine

Intervention Type 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

Interventions

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IV 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

Intervention Type DRUG

IV 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.

Intervention Type DRUG

Other Intervention Names

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NAC Placebo

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No