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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by Mads Werner, Rigshospitalet, Denmark.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01992146
First Posted: November 25, 2013
Last Update Posted: November 24, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Kentucky
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mads Werner, Rigshospitalet, Denmark
  Purpose

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.


Condition Intervention Phase
Central Nervous System Sensitization Pain Hyperalgesia Drug: Target-controlled naloxone-infusion Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of High-dose Naloxone Infusion on Pain and Hyperalgesia in Patients Following Groin-Hernia Repair. A Randomized, Placebo-controlled, Double-blind Crossover Study

Resource links provided by NLM:


Further study details as provided by Mads Werner, Rigshospitalet, Denmark:

Primary Outcome Measures:
  • Summated pain intensity [ Time Frame: 1st session: 6-8 weeks after surgery; 2nd session: one week later ]
    Change in pain ratings ([NRS,0-10] pain at rest + pain during transition from supine to standing position + pain during pressure (100 kPa) at injury site), assessed 6-8 weeks after unilateral, primary, open groin hernia repair following administration of naloxone/placebo.


Secondary Outcome Measures:
  • Secondary hyperalgesia/allodynia [ Time Frame: 1st session: 6-8 weeks after surgery; 2nd session: one week later ]
    Change in secondary hyperalgesia area/allodynia at surgical site and at the mirror-site in the contralateral groin assessed 6-8 weeks after unilateral, primary, open groin hernia repair following administration of naloxone/placebo.

  • Pressure pain thresholds [ Time Frame: 1st session: 6-8 weeks; 2nd session: one week later ]
    Change in pressure pain thresholds at surgical site and at the mirror-site in the contralateral groin assessed 6-8 weeks after unilateral, primary, open groin hernia repair following administration of naloxone/placebo.


Other Outcome Measures:
  • Pain Catastrophizing Scale [ Time Frame: in the 1st session: 6-8 weeks after surgery ]
    Patients fill out Pain Catastrophizing Scale before assessments on the first study day

  • Hospital Anxiety and Depression Scale [ Time Frame: in the 1st session: 6-8 weeks after surgery ]
    Patients fill out Hospital Anxiety and Depression Scale before assessments on the first study day

  • Clinical Opiate Withdrawal Scale [ Time Frame: 1st session: 6-8 weeks after surgery; 2nd session: one week later ]
    Clinical Opiate Withdrawal Scale is filled out before and during naloxone/placebo administration in each experimental session


Estimated Enrollment: 16
Study Start Date: November 2015
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 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.
Drug: Placebo
Experimental: 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.
Drug: Target-controlled naloxone-infusion

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992146


Contacts
Contact: Mads U Werner, M.D., D.M.Sc. +45 3545 7618 mads.u.werner@gmail.com
Contact: Anne Willum, A.P.R.N +45 3545 7623 anne.willum@hotmail.com

Locations
Denmark
Multidisciplinary Pain Center, 7612, HOC, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Mads U Werner, M.D., D.M.Sc    +45 3545 7618    mads.u.werner@gmail.com   
Contact: Anne Willum, A.P.R.N    +45 3545 7623    anne.willum@hotmail.com   
Sub-Investigator: Anne Willum, R.N.         
Sub-Investigator: Anders Springborg, M.S.         
Sponsors and Collaborators
Rigshospitalet, Denmark
University of Kentucky
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Mads U Werner, M.D., D.M.Sc. Rigshospitalet, Denmark
Study Director: Mads U Werner, M.D., D.M.Sc. Rigshospitalet, Denmark
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mads Werner, Physician, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01992146     History of Changes
Other Study ID Numbers: MP_SM01_2013
First Submitted: November 7, 2013
First Posted: November 25, 2013
Last Update Posted: November 24, 2015
Last Verified: November 2015

Keywords provided by Mads Werner, Rigshospitalet, Denmark:
central sensitization
endogenous opioids
humans
latent sensitization
naloxone
open groin hernia repair
pain
randomized controlled trial
secondary hyperalgesia
target-controlled infusion

Additional relevant MeSH terms:
Hernia
Hyperalgesia
Pathological Conditions, Anatomical
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents