NAC vs Placebo on Opioid Use for Hysterectomy

Sponsor

Medical University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06039566

Collaborator

(none)

240

Enrollment

Arms

24.5

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hysterectomy	Drug: IV N-acetylcysteine Drug: IV Placebo	Phase 3

Study Design

Study Type:

Interventional

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 25, 2023

Anticipated Primary Completion Date :

Sep 25, 2025

Anticipated Study Completion Date :

Oct 9, 2025

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: 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.	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. Other Names: Placebo
Active Comparator: 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.	Drug: 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 Other Names: NAC

Arm

Intervention/Treatment

Placebo Comparator: 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.

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.

Other Names:

Placebo

Active Comparator: 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.

Drug: 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

Other Names:

NAC

Outcome Measures

Primary Outcome Measures

Opioid Consumption 0-72 hours post-study medication [0-72 hours after study medication]
72-hour post-medication opioid consumption.

Secondary Outcome Measures

Pain Scores [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 Outcome Measures

intraoperative opioid consumption [during the procedure (up to 12 hours)]
Total morphine milligram equivalents administered during the procedure
postoperative anesthesia care unit (PACU) opioid consumption [PACU Arrival until PACU Discharge up to 52 weeks]
Total morphine milligram equivalents administered in the PACU
non-opioid analgesic administration [Anesthesia start until PACU discharge up to 52 weeks]
Total other pain medication administered during the procedure and in PACU

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator: Sylvia Wilson, M.D., Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sylvia Wilson, Professor of Anesthesiology, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT06039566

Other Study ID Numbers:

Pro00130489

First Posted:

Sep 15, 2023

Last Update Posted:

Sep 15, 2023

Last Verified:

Sep 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Sylvia Wilson, Professor of Anesthesiology, Medical University of South Carolina

hysterectomy

Additional relevant MeSH terms:

Acetylcysteine

N-monoacetylcystine

Study Results

No Results Posted as of Sep 15, 2023