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NCT04732000 · ClinicalTrials.gov registry record · Phase 2

Oxidative Stress and Surgical Recovery

A Phase 2 study of Pain, Postoperative and Surgical Recovery, sponsored by Stanford University.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target
1
Study location

NCT04732000: Completed Phase 2 study of Pain, Postoperative and Surgical Recovery, sponsored by Stanford University.

NCT04732000 is a Phase 2 study of Pain, Postoperative and Surgical Recovery that has completed, run by Stanford University. The registered enrollment target is 30 participants, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04732000, a Phase 2 study of Pain, Postoperative and Surgical Recovery, has completed, sponsored by Stanford University.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target
1
Study location

Study Summary

Chronic pain, functional impairment and slow rates of recovery are key issues for patients after surgery and trauma. No preventative strategy in current use unequivocally modifies these rates, and few novel approaches have been tested. Furthermore, persistent postsurgical pain is a major route to chronic opioid use, opioid use disorder and, regrettably, opioid overdose. Most strategies designed to limit chronic pain or enhance functional recovery after surgery are directed at modulating peripheral and central nervous system activity and do not strongly modify the underlying tissue pathophysiology or fundamental systemic responses. Strategies limiting oxidative stress in the perioperative period, on the other hand, might limit tissue damage, organ dysfunction and immune system activation. N-acetyl cysteine (NAC) is an antioxidant well-studied in the perioperative period; it is very safe, relatively inexpensive and widely available. The central hypothesis is, therefore, that perioperative administration of NAC will reduce perioperative oxidative stress, limit immune system activation and improve key indices of surgical recovery. Although the planned work will not comprehensively address this hypothesis, it will identify the most useful tools and help the researchers estimate the required sample sizes for more definitive externally funded efforts.

Primary Outcome

STAT3 phosphorylation in MDSC cells is measured in all MDSC cells before (T0) and one day after surgery (T1) using mass cytometry. The median phosphorylation in this cell population is then determined for each time point. The change in phosphorylation is expressed as the arc sinh ratio of these two medians (ratio = arc sinh \[median pSTAT3-T1/median pSTAT3-T0\]).

Interventions

  • OTHER Normal Saline
  • DRUG N-acetyl cysteine

Study Locations (1)

California

  • Stanford University School of Medicine - Stanford

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2021-07-01
Est. Completion 2023-03-01
Phase Phase 2
Stanford University

1,744 total trials

What the finished NCT04732000 record still lists

NCT04732000 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 273-participant average among 113 other Pain, Postoperative trials with a reported enrollment target (89% lower).

The record links to 2 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 2 interventions - of which Normal Saline is the first listed.

NCT04732000 reports a single indexed study location in California.

Frequently Asked Questions

What is clinical trial NCT04732000 about?

NCT04732000 is a clinical study titled "Oxidative Stress and Surgical Recovery". Chronic pain, functional impairment and slow rates of recovery are key issues for patients after surgery and trauma. No preventative strategy in current use unequivocally modifies these rates, and few novel approaches have been tested. Furthermore, persistent postsurgical pain is a major route to ch...

What is the current status of trial NCT04732000?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2021-07-01. Estimated completion is 2023-03-01.

What conditions does trial NCT04732000 study?

This clinical trial studies the following conditions: Pain, Postoperative, Surgical Recovery.

What interventions are being tested in trial NCT04732000?

The interventions under investigation include: Normal Saline (OTHER), N-acetyl cysteine (DRUG).

Who is sponsoring clinical trial NCT04732000?

This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04732000 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pain, Postoperative

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04732000's enrollment target sits among peer trials

30 104th of 113 higher than 8 of 113 other Pain, Postoperative trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pain, Postoperative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04732000, the US trial registry maintained by the National Library of Medicine. NCT04732000 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.