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Antioxidant

Antioxidant Therapy for Postoperative Recovery

Phase 2

Waitlist Available

Led By Martin S Angst, MD

Research Sponsored by Stanford University

Eligibility Criteria Checklist

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

Must have

Over 18

Planning to undergo primary total hip arthroplasty

Timeline

Screening 3 weeks

Treatment Varies

Follow Up composite scores over 24 hours following surgery.

Awards & highlights

Study Summary

This trial will test whether the antioxidant N-acetyl cysteine (NAC) can reduce chronic pain and improve functional recovery after surgery.

Who is the study for?

This trial is for adults over 18 who are fluent in English and preparing for primary total hip arthroplasty. They must be willing to sign a consent form and follow study procedures.Check my eligibility

What is being tested?

The trial is testing if N-acetyl cysteine (NAC), an antioxidant, can reduce oxidative stress and improve recovery after surgery compared to normal saline.See study design

What are the potential side effects?

NAC is generally very safe with minimal side effects; however, it may cause nausea, vomiting, rash or headache. Normal saline typically has no side effects.

Eligibility Criteria

Inclusion Criteria

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

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I am over 18 years old.

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I am scheduled for a first-time hip replacement surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ composite scores over 24 hours following surgery.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~composite scores over 24 hours following surgery.

This trial's timeline: 3 weeks for screening, Varies for treatment, and composite scores over 24 hours following surgery. for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Phosphorylation of STAT-3 in MDSC (myeloid-derived suppressor cells)

Secondary outcome measures

Pain score

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: N-acetyl cysteineActive Control1 Intervention

N-acetyl cysteine will be administered as follows: A loading dose of 50 mg/kg will be started as a 1-hour infusion before surgical incision, and will be followed by a maintenance dose of 50 mg/kg administered over 4 hours.

Group II: Normal SalinePlacebo Group1 Intervention

Normal will be administered as follows: A normal saline infusion will administered at a rate and duration to mimic the N-acetyl cysteine administration.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor

2,394 Previous Clinical Trials

17,341,589 Total Patients Enrolled

7 Trials studying Postoperative Pain

1,042 Patients Enrolled for Postoperative Pain

Martin S Angst, MDPrincipal InvestigatorStanford University

5 Previous Clinical Trials

176 Total Patients Enrolled

Frequently Asked Questions

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

Has N-acetyl cysteine been given the go-ahead by regulatory bodies?

"Taking into account the Phase 2 status of N-acetyl cysteine, our team assessed its safety as a 2 on a scale from 1 to 3 due to the existing evidence for its protection."

Answered by AI

How many participants are currently signed up for the experiment?

"This clinical trial is no longer accepting participants. It was first published on July 1st 2021 and the last update occured November 8th 2022. Currently, there are 483 medical trials searching for patients with pain, postoperative conditions as well as 24 studies actively recruiting participants to explore N-acetyl cysteine's potential benefits."

Answered by AI

Is enrollment currently open for this research experiment?

"This trial has concluded recruitment, having first been posted on July 1st 2021 and most recently edited on November 8th 2022. For those seeking to join a clinical study, there are 483 trials related to pain management still recruiting participants alongside 24 studies involving N-acetyl cysteine that are actively admitting new patients."

Answered by AI

Recent research and studies

AnesthesiologyJournal

Patient-specific Immune States Before Surgery Are Strong Correlates of Surgical Recovery

Fragiadakis, Gabriela K., Brice Gaudillière, Edward A. Ganio, Nima Aghaeepour, Martha Tingle, Garry P. Nolan, and Martin S. Angst. 2015. “Patient-specific Immune States Before Surgery Are Strong Correlates of Surgical Recovery”. Anesthesiology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aln.0000000000000887.

The Journal of ArthroplastyJournal

Predictive Factors for Developing Chronic Pain After Total Knee Arthroplasty

Kim, David H., Kristine M. Pearson-Chauhan, Robert J. McCarthy, and Asokumar Buvanendran. 2018. “Predictive Factors for Developing Chronic Pain After Total Knee Arthroplasty”. The Journal of Arthroplasty. Elsevier BV. doi:10.1016/j.arth.2018.07.028.

Science Translational MedicineJournal

Aldehyde Dehydrogenase-2 Regulates Nociception in Rodent Models of Acute Inflammatory Pain

Zambelli, Vanessa O., Eric R. Gross, Che-Hong Chen, Vanessa P. Gutierrez, Yara Cury, and Daria Mochly-Rosen. 2014. “Aldehyde Dehydrogenase-2 Regulates Nociception in Rodent Models of Acute Inflammatory Pain”. Science Translational Medicine. American Association for the Advancement of Science (AAAS). doi:10.1126/scitranslmed.3009539.

Health and Quality of Life OutcomesJournal