Health TrialsbyHealthPanel

NAC vs Placebo on Opioid Use for Hysterectomy

ConditionHysterectomy
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorMedical University of South Carolina

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

18 years of age and older

Less than 40kg in weight

Unable to provide written, informed consent

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

  • 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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: IV PlaceboPlacebo comparator 1 intervention
Group B: IV N-acetylcysteineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Opioid Consumption 0-72 hours post-study medication

72-hour post-medication opioid consumption.

Time frame
0-72 hours after study medication

Secondary outcomes

1

Pain Scores

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.

Time frame
Study medication start to 72 hours post-study medication

Other outcomes

1

intraoperative opioid consumption

Total morphine milligram equivalents administered during the procedure

Time frame
during the procedure (up to 12 hours)
2

postoperative anesthesia care unit (PACU) opioid consumption

Total morphine milligram equivalents administered in the PACU

Time frame
PACU Arrival until PACU Discharge up to 52 weeks
3

non-opioid analgesic administration

Total other pain medication administered during the procedure and in PACU

Time frame
Anesthesia start until PACU discharge up to 52 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Medical University of South Carolina

Lead sponsor

Source ClinicalTrials.gov
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