Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
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):
Emiliano Tognoli, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Tracking Information
First Submitted Date  ICMJE May 5, 2012
First Posted Date  ICMJE May 8, 2012
Last Update Posted Date May 16, 2012
Study Start Date  ICMJE December 2009
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 7, 2012)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone
Official Title  ICMJE Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone
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.
Detailed Description not desired
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Post Operative Pain
  • Hyperalgesia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Intervention: Drug: ketamine infusion
  • Experimental: zero/metadone
    patients received a standard balance anaesthesia and methadone by PCA device for postoperative pain
    Intervention: Drug: Methadone PCA
  • Experimental: ketamine/methadone
    Patients received a balance anaesthesia supplemented with low dose of ketamine and Methadone by PCA device for postoperative pain
    Interventions:
    • Drug: ketamine infusion
    • Drug: Methadone PCA
Publications * Tognoli E, Proto PL, Motta G, Galeone C, Mariani L, Valenza F. Methadone for postoperative analgesia: contribution of N-methyl-D-aspartate receptor antagonism: A randomised controlled trial. Eur J Anaesthesiol. 2020 Oct;37(10):934-943. doi: 10.1097/EJA.0000000000001217.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 7, 2012)
96
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2012
Estimated Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01594047
Other Study ID Numbers  ICMJE metadone
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Emiliano Tognoli, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Study Sponsor  ICMJE Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emiliano Tognoli Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
PRS Account Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP