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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: June 1, 2012

Detailed Description

not desired

Interventions

  • 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
  • Drug: Methadone PCA
    • Methadone administered by a PCA system (dose 2 mg, lock-out 12min.)

Arms, Groups and Cohorts

  • No Intervention: zero/morphine
    • Patient received a standard balance anaesthesia and morphine for post operative pain.
  • Experimental: ketamine/morphine
    • 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.
  • Experimental: zero/metadone
    • Methadone PCA
  • Experimental: ketamine/methadone
    • 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. Methadone administered by a PCA system (dose 2 mg, lock-out 12min.).

Clinical Trial Outcome Measures

Primary Measures

  • 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 lines at a right angle to the top, middle, and bottom sides of the surgical incision. Each line starts from the edge of the abdomen to the surgical incision. Stimulation continue from the edge toward the surgical incision until the patients reported a worsening in sensation The distance from the incision to where sensation change was measured. The mean of the three assessments was used as a measure of the extent of the hyperalgesia area.

Secondary Measures

  • Pain Intensity Measured by a Numeric Rating Scale (NRS)
    • Time Frame: 24 and 48 hours after surgery
    • A Numerical Rating Scale (NRS) from 0 to 10 is used as a measure of pain intensity. Zero indicates the absence of any pain and 10 the worse pain never felt.
  • Opioid Consumption
    • Time Frame: 48 hours
    • Cumulative opioid consumption at 48 hours from surgery ( end of the study)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  • Provider of Information About this Clinical Study
    • Principal Investigator: Emiliano Tognoli, medical doctor – Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
  • Overall Official(s)
    • Emiliano Tognoli, Principal Investigator, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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