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

NCT03354572 | Completed Phase 4 DMC

• 1 other identifier: NAC.TEP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• pain score day 1 after surgery

  To evaluate the efficacy of intravenous NAC in comparison with placebo in terms of pain relief after laparoscopic inguinal hernia repair measured by a visual analogue scale (VAS 0-100 millimeters) at day 1 after surgery. The higher the score, the more pain the patient has.

  24 hours

Secondary Outcomes (7)

• direct postoperative pain

  <1 hours

• time to first pain medication

  <4hours

• total consumption of opiates

  <4 hours

• time to discharge

  24 hours

• postoperative dosage of analgesics

  72 hours

Study Arms (2)

NAC

ACTIVE COMPARATOR

receive 150 mg/kg acetylcysteïne in 200 ml saline (NaCl0,9%) prior to surgery

Drug: Acetyl cysteine

placebo

PLACEBO COMPARATOR

receive only NaCl 0.9% prior to surgery (volume identical to active comparator)

Drug: Placebos

Interventions

Acetyl cysteine DRUG

acetyl cysteine 150 mg/kg prior to surgery

Also known as: NAC

NAC

Placebos DRUG

saline 0.9% prior to surgery

Also known as: Saline 0.9%

placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects scheduled for laparoscopic unilateral inguinal hernia repair
• ASA 1 or2.
• Age \>18 years.

You may not qualify if:

• Pregnancy or lactating
• Allergy to NAC
• History of chronic pain
• Use of opioids or neuropathic analgesics
• Use of NAC prior to trial (\< 1 month of planned surgery)
• Alcoholism
• Diabetes Mellitus (insulin therapy)
• Asthma or Chronic Obstructive pulmonary Disease
• Known renal function disorders (MDRD \<ô0)
• Known liver failure (bilirubin \>1.Sx upper limit of normal)
• No written lC by patient

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Maxima Medical Center: collaborator

Study Sites (1)

Maxima Medical Centre

Eindhoven, North Brabant, 5631BM, Netherlands

Location

Related Publications (1)

• Mulkens CE, Staatsen M, van Genugten L, Snoeker BAM, Vissers KCP, Bruhn J, Bucx MJL. Postoperative pain reduction by pre-emptive N-acetylcysteine: an exploratory randomized controlled clinical trial. Reg Anesth Pain Med. 2021 Nov;46(11):960-964. doi: 10.1136/rapm-2021-102884. Epub 2021 Aug 26.

  PMID: 34446544 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Acetylcysteine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Kris Vissers, MD, PhD

  Chair

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will be a single centre double blinded randomized placebo controlled trial

Study Record Dates

• First Submitted: October 25, 2017
• First Posted: November 28, 2017
• Study Start: October 20, 2017
• Primary Completion: October 29, 2018
• Study Completion: October 29, 2018
• Last Updated: August 13, 2019

Record last verified: 2019-02

Locations

NL (1)