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A Pilot Trial to Determine the Effective N-acetylcysteine Dose for Opioid Reduction for Spine Surgery.

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ClinicalTrials.gov Identifier: NCT04562597
Recruitment Status : Recruiting
First Posted : September 24, 2020
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
Sylvia Wilson, Medical University of South Carolina

Study Description
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Brief Summary:
Determine the optimal dose of IV N-acetylcysteine (NAC) to produce opioid reduction following spine surgery and estimate the difference in opioid consumption between placebo and the selected optimal dose.

Condition or disease Intervention/treatment Phase
Surgery Drug: Dose Response Curve Placebo Drug: Dose Response Curve N-acetylcysteine 50 mg/kg Drug: Dose Response Curve N-acetylcysteine 100 mg/kg Drug: Dose Response Curve N-acetylcysteine 150 mg/kg Drug: Opioid Reduction with Optimal N-acetylcysteine Dose Drug: Placebo Phase 1 Phase 2

Detailed Description:

First 20 subjects: 5 participants will be randomized to each dose group (placebo, 50, 100, and 150 mg/kg) to estimate the dose response curve and to identify the optimal dose.

If the dose response curve is adequate and the optimal dose identified, 15 additional participants will be randomized to placebo and 15 to the optimal dose to estimate the difference in opioid consumption between participants on placebo vs. the optimal dose. (Total of 50 subjects with 20 from dose response curve and 30 to estimate the difference in opioid consumption.)

If the dose response curve is not adequate after the initial 20 subjects 5 per each dose group, then an additional 5 participants will be randomized and to each dose group (placebo, 50, 100, and 150 mg/kg) to estimate the dose response curve and to identify the optimal dose. Once the optimal dose is identified with these initial 40 patients, 10 additional participants will be randomized to placebo and 10 to the optimal dose to estimate the difference in opioid consumption between participants on placebo vs. the optimal dose. (60 patients total with 40 to create the dose response curve and 20 more to estimate the difference in opioid consumption.)

A sample size of 20 subjects per group (placebo and optimal dose) allows us to estimate a 95% confidence interval for the mean difference in opioid consumption with a width of + 0.64 standard deviations from the mean. 70 subjects may be enrolled to account for withdrawal but the study will be completed once 50 or 60 subjects (based on the number of subjects required to create the dose response curve) have completed the protocol.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:

First 20 subjects: We will initially randomize 5 patients to each dose group (placebo, 50, 100, and 150 mg/kg) to estimate the dose response curve and to identify the optimal dose. After enrollment of the first 20 patients, the study will undergo review by the study team and statistician.

If the dose response curve is adequate and the optimal dose identified, 15 additional participants will be randomized to placebo and 15 to the optimal dose to estimate the difference in opioid consumption between patients on placebo vs. the optimal dose.
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Pilot Trial to Determine the Effective Dose of N-acetylcysteine for Opioid Reduction in Patients Undergoing Spine Surgery.
Actual Study Start Date : January 20, 2021
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : July 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Dose Response Curve Placebo
5-10 participants will be randomized to the placebo group to estimate the dose response curve and to identify the optimal dose.
 Drug: Dose Response Curve Placebo
5-10 participants will be randomized to the placebo group to estimate the dose response curve and to identify the optimal dose.
Active Comparator: Dose Response Curve N-acetylcysteine 50 mg/kg
5-10 participants will be randomized to the N-acetylcysteine 50 mg/kg group to estimate the dose response curve and to identify the optimal dose.
 Drug: Dose Response Curve N-acetylcysteine 50 mg/kg
5-10 participants will be randomized to the N-acetylcysteine 50 mg/kg group to estimate the dose response curve and to identify the optimal dose.
Active Comparator: Dose Response Curve N-acetylcysteine 100 mg/kg
5-10 participants will be randomized to the N-acetylcysteine 100 mg/kg group to estimate the dose response curve and to identify the optimal dose.
 Drug: Dose Response Curve N-acetylcysteine 100 mg/kg
5-10 participants will be randomized to the N-acetylcysteine 100 mg/kg group to estimate the dose response curve and to identify the optimal dose.
Active Comparator: Dose Response Curve N-acetylcysteine 150 mg/kg
5-10 participants will be randomized to the N-acetylcysteine 150 mg/kg group to estimate the dose response curve and to identify the optimal dose.
 Drug: Dose Response Curve N-acetylcysteine 150 mg/kg
5-10 participants will be randomized to the N-acetylcysteine 150 mg/kg group to estimate the dose response curve and to identify the optimal dose.
Experimental: Opioid Reduction with Optimal N-acetylcysteine Dose
Once the optimal N-acetylcysteine dose is identified, 10-15 additional participants will be randomized to the optimal dose to estimate the difference in opioid consumption between patients on placebo vs. the optimal dose.
 Drug: Opioid Reduction with Optimal N-acetylcysteine Dose
Once the optimal N-acetylcysteinedose is identified, 10-15 participants will be randomized to the optimal dose (50,100, or 150 mg/kg) to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.
Placebo Comparator: Placebo
10-15 Participants will be randomized to placebo to estimate the difference in opioid consumption between patients on placebo vs. the optimal dose.
 Drug: Placebo
10-15 Participants will be randomized to placebo to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.


Outcome Measures
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Primary Outcome Measures :
  1. Opioid consumption 12 hours post operative [ Time Frame: 12 hours ]
    Post operative opioid consumption


Secondary Outcome Measures :
  1. Opioid consumption 6 hours post operative [ Time Frame: 6 hours ]
    Post operative opioid consumption


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Undergoing elective spine surgery involving 4 levels or less of the thoracic, lumbar, or sacral spine.
  • 18 years of age and older.

Exclusion Criteria:

  • 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.
  • Pregnant Women
  • Known blood clotting deficiency
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04562597


Contacts
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Contact: Sylvia Wilson, MD 843-792-2322 wilsosh@musc.edu
Contact: Haley Nitchie 8437921869 nitchie@musc.edu

Locations
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United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact: Sylvia Wilson, MD    843-792-2322    wilsosh@musc.edu   
Principal Investigator: Sylvia Wilson, MD         
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Sylvia Wilson, MD Medical University of South Carolina
More Information
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Publications:

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Responsible Party: Sylvia Wilson, Professor, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT04562597    
Other Study ID Numbers: Pro00099062
First Posted: September 24, 2020    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Acetylcysteine
N-monoacetylcystine
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Expectorants
 Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes