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

NCT03354572 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-08-13

No results posted yet for this study

Summary

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.

Conditions

  • Postoperative Pain

Interventions

DRUG

Acetyl cysteine

acetyl cysteine 150 mg/kg prior to surgery

DRUG

Placebos

saline 0.9% prior to surgery

Sponsors & Collaborators

  • Maxima Medical Center

    collaborator OTHER

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Kris Vissers, MD, PhD · Chair

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-20
Primary Completion
2018-10-29
Completion
2018-10-29

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03354572 on ClinicalTrials.gov