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 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
    • patients received a balance anaesthesia supplemented by low dose of ketamine and Morphine by PCA device for postoperative pain
  • Experimental: zero/metadone
    • patients received a standard balance anaesthesia and methadone by PCA device for postoperative pain
  • Experimental: ketamine/methadone
    • Patients received a balance anaesthesia supplemented with low dose of ketamine and Methadone by PCA device for postoperative pain

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 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 Measures

  • pain intensity
    • Time Frame: 24 and 40 hours after surgery
    • A Numerical rating scale is used to quantifie pain intensity
  • opioids related adverse events
    • Time Frame: 24 and 48 hours after surgery
    • post operative nause and vomiting, respiratory depression.

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
  • Overall Contact(s)
    • Emiliano Tognoli, 02/23902176, Emiliano.Tognoli@istitutotumori.mi.it

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.