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NCT03354572

Pilot Study: Postoperative Pain Reduction by Pre Emptive N-Acetylcysteine

Completed Phase 4 Last updated 13 August 2019
What this trial tests

Phase 4 trial testing Acetyl cysteine in Postoperative Pain in 60 participants. Completed in 29 October 2018.

Timeline
20 October 2017
Primary endpoint
29 October 2018
29 October 2018

Quick facts

Lead sponsorRadboud University Medical Center
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposetreatment
Enrollment60
Start date20 October 2017
Primary completion29 October 2018
Estimated completion29 October 2018
Sites1 location across Netherlands

Drugs / interventions tested

Conditions studied

Sponsor

Radboud University Medical Center

Who can join

18 and older, any sex, with Postoperative Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Despite current available analgesic drugs, post-surgical pain management remains challenging. A potential new target for analgesic drugs are group-II metabotropic glutamate receptors subtypes (mGlu2 and mGlu3 receptors), since growing evidence from animal models show that activation of these receptors produce s analgesic effects in inflammatory and in neuropathic pain states. . N-Acetylcysteine (NAC) is a safe agent and with little to no side effects. NAC can induce analgesia by activating the glutamate:cystein antiporter, causing endogenous activation of the mGlu 2/3 receptors. However, this has only been investigated once in the peri-operative setting, were it showed preliminary promising result of reduction in opiate necessity. In healthy subjects there was a significant reduction in pain ratings to laser stimuli and amplitudes of laser evoked potentials after NAC. Based on these promising results, we hypothesize that pre emptive intravenous NAC can reduce postoperative pain and thereby cause less necessity for escape analgesics like opiates.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Iron homeostasis and ferroptosis in human diseases: mechanisms and therapeutic prospects.
    Ru Q, Li Y, Chen L, Wu Y, et al · · 2024 · cited 365× · PMID 39396974 · DOI 10.1038/s41392-024-01969-z
  2. Ferroptosis in Cancer and Inflammatory Diseases: Mechanisms and Therapeutic Implications.
    Shen G, Liu J, Wang Y, Deng Z, et al · · 2025 · cited 6× · PMID 40919133 · DOI 10.1002/mco2.70349
  3. Postoperative pain reduction by pre-emptive N-acetylcysteine: an exploratory randomized controlled clinical trial.
    Mulkens CE, Staatsen M, van Genugten L, Snoeker BAM, et al · · 2021 · cited 6× · PMID 34446544 · DOI 10.1136/rapm-2021-102884

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Other trials of Acetyl cysteine

Trials testing the same drug.

Other recruiting trials for Postoperative Pain

Currently open trials in the same condition.

Other Radboud University Medical Center trials

Trials by the same sponsor.

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Data sources for this page

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