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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

9 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-11

Study Completion Date

2018-05-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Central Nervous System Sensitization Pain Hyperalgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Change in Pain Ratings (NRS) at the surgical site and at the mirror-site in the contralateral groin six to eight weeks after unilateral herniotomy following administration of placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Target-controlled naloxone-infusion (total dose: 3.25 mg/kg)

Change in Pain Ratings (NRS) at the surgical site and at the mirror-site in the contralateral groin six to eight weeks after unilateral herniotomy following administration of naloxone.

Group Type EXPERIMENTAL

Target-controlled naloxone-infusion

Intervention Type DRUG

Interventions

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Target-controlled naloxone-infusion

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18 years and ≤ 65 years
* Signed informed consent
* Patients submitted to unilateral, primary inguinal, open herniotomy 6-8 weeks prior to study start.
* Open operating procedure a.m. Lichtenstein.
* Urin sample without traces of opioids (morphine, methadon, buprenorphine, codeine, tramadol, ketobemidone, oxycodone, hydromorphine, dextromethorphan)
* ASA I-II
* Body mass index (BMI): 18 \< BMI \< 30

Exclusion Criteria

* Volunteers , who do not speak or understand Danish
* Patients, who cannot cooperate with the investigation
* Patients who have had previous surgery in the groin region
* Patients with pain at rest \> 3 (NRS)
* Activity-related pain in the surgical field \> 5
* Allergic reaction against morphine or other opioids (including naloxone),
* Abuse of alcohol or drugs - according to investigator's evaluation
* Use of psychotropic drugs (exception of SSRI)
* Neurologic or psychiatric disease
* Chronic pain condition
* Regular use of analgesic drugs
* Skin lesions and tattoos in the assessment areas
* Nerve lesions in the assessment sites (for instance, after trauma, disc herniation, etc.)
* Use of prescription drugs 1 week before the trial
* Use of over-the-counter drugs 48 hours before the trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No