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Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone

This study is currently recruiting participants.
Verified May 2012 by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor:
Information provided by (Responsible Party):
Emiliano Tognoli, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier:
NCT01594047
First received: May 5, 2012
Last updated: May 15, 2012
Last verified: May 2012
History of Changes
  Purpose

Background: In perioperative period inhibition of N-Methyl-D-Aspartate receptor prevents opioid-induced hyperalgesia and reduce postoperative opioid requirement after abdominal surgery. Methadone is both a µ-opioid receptor agonist like Morphine and a N-Methyl-D-Aspartate antagonist. Study Aim. To evaluate the efficacy of intraoperative Ketamine and postoperative Methadone analgesia in preventing opioid-induced hyperalgesia after abdominal surgery.


Condition Intervention
Post Operative Pain
Hyperalgesia
 Drug: ketamine infusion
Drug: Methadone PCA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:

Primary Outcome Measures:
  • the extent of hyperalgesia area proximal to surgical wound [ Time Frame: 24 and 48 hours after surgery ] [ Designated as safety issue: No ]

    Hyperalgesia is determined by stimulating with a won Fray hair N°16 along three line at right angle to the top, middle and bottom sides of the surgical incision. Each line start from the edge of abdomen to the surgical incision.

    Stimulation continue from edge toward the surgical incision untill the patients reported a worsening in sensation The distance from the incision to where sensation change was measured and the three assessments was calculated



Secondary Outcome Measures:
  • pain intensity [ Time Frame: 24 and 40 hours after surgery ] [ Designated as safety issue: No ]
    A Numerical rating scale is used to quantifie pain intensity

  • opioids related adverse events [ Time Frame: 24 and 48 hours after surgery ] [ Designated as safety issue: No ]
    post operative nause and vomiting, respiratory depression.


Estimated Enrollment: 96
Study Start Date: December 2009
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: zero/morphine
Patient received a standard balance anaesthesia and morphine for post operative pain.
Experimental: ketamine/morphine
patients received a balance anaesthesia supplemented by low dose of ketamine and Morphine by PCA device for postoperative pain
 Drug: ketamine infusion
Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery
Other Name: hyperalgesia-blocker
Experimental: zero/metadone
patients received a standard balance anaesthesia and methadone by PCA device for postoperative pain
 Drug: Methadone PCA
Methadone administered by a PCA system (dose 2 mg, lock-out 12min.)
Other Name: hyperalgesia-blocker
Experimental: ketamine/methadone
Patients received a balance anaesthesia supplemented with low dose of ketamine and Methadone by PCA device for postoperative pain
 Drug: ketamine infusion
Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery
Other Name: hyperalgesia-blocker
Drug: Methadone PCA
Methadone administered by a PCA system (dose 2 mg, lock-out 12min.)
Other Name: hyperalgesia-blocker

Detailed Description:

not desired

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing open colo-rectal surgery

Exclusion Criteria:

  • ASA status more than II, history of chronic pain, ischemic heart disease or chronic pulmonary disease, allergy to any drugs used in the protocol. Body Max Index more than 35.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594047

Contacts
Contact: Emiliano Tognoli 02/23902176 Emiliano.Tognoli@istitutotumori.mi.it
Contact: Langer Martin 02/23902282 Martin.Langer@istitutotumori.mi.it

Locations
Italy
Fondazione IRCCS Istituto Nazionale dei Tumori Recruiting
Milano, Italy, 20133
Principal Investigator: Emiliano Tognoli            
Sponsors and Collaborators
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Investigators
Principal Investigator: Emiliano Tognoli Fondazione IRCCS Istituto Nazionale dei Tumori
  More Information

No publications provided

Responsible Party: Emiliano Tognoli, medical doctor, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
ClinicalTrials.gov Identifier: NCT01594047     History of Changes
Other Study ID Numbers: metadone
Study First Received: May 5, 2012
Last Updated: May 15, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano:
hyperalgesia
Patient controlled analgesia
morphine
methadone
ketamine

Additional relevant MeSH terms:
Hyperalgesia
Pain, Postoperative
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Pain
Ketamine
Methadone
Morphine
Analgesics, Opioid
Anesthetics, Dissociative
 Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013