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NCT Number: NCT06039566

NAC vs Placebo on Opioid Use for Hysterectomy

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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Key information

Conditions

Hysterectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location status: Recruiting

Location contact

Sylvia Wilson, MD

CONTACT

[email protected]

843-792-2322

Sylvia Wilson, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: NAC

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.

Other names: Placebo

Primary outcomes

  1. Opioid Consumption 0-72 hours post-study medication

    Time frame: 0-72 hours after study medication

    72-hour post-medication opioid consumption.

Secondary outcomes

  1. Pain Scores

    Time frame: Study 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.

Other outcomes

  1. intraoperative opioid consumption

    Time frame: during the procedure (up to 12 hours)

    Total morphine milligram equivalents administered during the procedure

  2. postoperative anesthesia care unit (PACU) opioid consumption

    Time frame: PACU Arrival until PACU Discharge up to 52 weeks

    Total morphine milligram equivalents administered in the PACU

  3. non-opioid analgesic administration

    Time frame: Anesthesia start until PACU discharge up to 52 weeks

    Total other pain medication administered during the procedure and in PACU

Study contacts

Contact information is provided by the study sponsor or research team.

Haley Nitchie, MHA

CONTACT

[email protected]

843-792-1869

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 15, 2023
Registry last updated
Oct 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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