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

Condition(s) targeted: Post Operative Pain; Hyperalgesia

Intervention: ketamine infusion (Drug); Methadone PCA (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Official(s) and/or principal investigator(s):
Emiliano Tognoli, Principal Investigator, Affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori

Overall contact:
Emiliano Tognoli, Phone: 02/23902176, Email: Emiliano.Tognoli@istitutotumori.mi.it

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.

Official title: Perioperative Opioid-induced Hyperalgesia and Its Prevention With Ketamine and Methadone

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: the extent of hyperalgesia area proximal to surgical wound

Secondary outcome:

pain intensity

opioids related adverse events

Detailed description: not desired

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

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.

Emiliano Tognoli, Phone: 02/23902176, Email: Emiliano.Tognoli@istitutotumori.mi.it

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano 20133, Italy; Recruiting
Emiliano Tognoli, Principal Investigator

Starting date: December 2009
Last updated: May 15, 2012