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

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ClinicalTrials.gov Identifier: NCT01594047
Recruitment Status : Unknown
Verified May 2012 by Emiliano Tognoli, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano.
Recruitment status was:  Recruiting
First Posted : May 8, 2012
Last Update Posted : May 16, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Post Operative Pain Hyperalgesia Drug: ketamine infusion Drug: Methadone PCA

Detailed Description:
not desired

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone
Study Start Date : December 2009
Estimated Primary Completion Date : June 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. the extent of hyperalgesia area proximal to surgical wound [ Time Frame: 24 and 48 hours after surgery ]

    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 :
  1. pain intensity [ Time Frame: 24 and 40 hours after surgery ]
    A Numerical rating scale is used to quantifie pain intensity

  2. opioids related adverse events [ Time Frame: 24 and 48 hours after surgery ]
    post operative nause and vomiting, respiratory depression.


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): 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

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
First Posted: May 8, 2012    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012

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

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