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N-acetylcysteine for Post-Hysterectomy Pain

Phase 3

Recruiting

Led By Sylvia Wilson, M.D.

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18 years of age and older

Insulin dependent diabetes if D5W is required

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-72 hours after study medication

Awards & highlights

Study Summary

This trial studies the effects of a drug given during a hysterectomy on the amount of pain experienced afterwards. Participants will be asked to report their pain levels.

Who is the study for?

This trial is for women aged 18 or older who are having a laparoscopic or robotic hysterectomy. They must be able to give informed consent and speak English. It's not for those with a bad reaction to acetylcysteine, active asthma, under 40kg in weight, or insulin-dependent diabetes needing D5W.Check my eligibility

What is being tested?

The study tests if IV N-acetylcysteine can reduce pain and opioid use after a hysterectomy compared to an IV placebo. Participants will randomly receive one of the treatments during surgery and report their pain levels and medication use afterward.See study design

What are the potential side effects?

N-acetylcysteine may cause allergic reactions, respiratory symptoms like wheezing (especially in asthmatics), gastrointestinal disturbances, or skin rashes. The severity of side effects varies among individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I need insulin and D5W for my diabetes.

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I have active asthma or wheezing, or I use inhalers for breathing.

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I am scheduled for a laparoscopic or robotic hysterectomy.

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I weigh less than 40kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-72 hours after study medication

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-72 hours after study medication

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-72 hours after study medication for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Opioid Consumption 0-72 hours post-study medication

Secondary outcome measures

Pain Scores

Other outcome measures

intraoperative opioid consumption

non-opioid analgesic administration

postoperative anesthesia care unit (PACU) opioid consumption

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: IV N-acetylcysteineActive Control1 Intervention

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 II: IV PlaceboPlacebo Group1 Intervention

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.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,396 Total Patients Enrolled

Sylvia Wilson, M.D.Principal InvestigatorMedical University of South Carolina

1 Previous Clinical Trials

117 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you tell me if enrollment is open for this clinical experiment?

"According to clinicaltrials.gov, this medical trial is in the process of recruiting volunteers and has been since November 30th 2023 as per its most recent update on December 1st."

Answered by AI

Is IV N-acetylcysteine a secure form of treatment for individuals?

"The safety profile of IV N-acetylcysteine is rated a 3 due to the evidence presented in Phase 3 trials that show both efficacy and multiple rounds of data attesting its safety."

Answered by AI

To what extent is this scientific investigation utilizing volunteers?

"Affirmative. Clinicaltrials.gov records show that this clinical trial is currently seeking applicants, which were first posted on November 30th 2023 and was most recently updated on December 1st 2023. This experiment requires the participation of 240 people from a single medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

NAC vs Placebo on Opioid Use for Hysterectomy

Sylvia Wilson 2023. "NAC vs Placebo on Opioid Use for Hysterectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06039566.