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Effect of High-dose Naloxone Infusion on Pain and Hyperalgesia in Patients Following Groin-Hernia Repair.

NCT01992146 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2024-02-22

No results posted yet for this study

Summary

Recent studies have focused on the role of endogenous opioids on central sensitization. Central sensitization is known to be impaired or altered in chronic pain conditions, as fibromyalgia or chronic tension headache.

Animal studies have shown reinstatement of mechanical hypersensitivity following naloxone administration after resolution of an injury. This suggests latent sensitization.

In the present study, investigators hypothesize that a high-dose target-controlled naloxone infusion (total dose: 3.25 mg/kg) can reinstate pain and hyperalgesia 6-8 weeks after a unilateral primary open groin hernia repair procedure. Investigators aim to show that latent sensitization is present in humans and is modulated by endogenous opioids.

Conditions

  • Central Nervous System Sensitization
  • Pain
  • Hyperalgesia

Interventions

DRUG

Target-controlled naloxone-infusion

DRUG

Placebo

Sponsors & Collaborators

  • University of Kentucky

    collaborator OTHER

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Mads U Werner, M.D., D.M.Sc. · Rigshospitalet, Denmark

  • Mads U Werner, M.D., D.M.Sc. · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-11
Primary Completion
2015-12-14
Completion
2018-05-11

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01992146 on ClinicalTrials.gov