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

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Status: Completed

Conditions: Hyperalgesia; Post Operative Pain

Treatments: Drug: ketamine infusion; Drug: Methadone PCA

Study type: Interventional

Funder types: Other

Identifiers

NCT01594047

metadone

Details and patient eligibility

About

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.

Full description

not desired

Enrollment: 113 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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113 participants in 4 patient groups

zero/morphine

No Intervention group

Description:

Patient received a standard balance anaesthesia and morphine for post operative pain.

ketamine/morphine

Experimental group

Description:

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.

Treatment:

Drug: ketamine infusion

zero/metadone

Experimental group

Description:

Methadone PCA

Treatment:

Drug: Methadone PCA

ketamine/methadone

Experimental group

Description:

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.).

Treatment:

Drug: Methadone PCA

Drug: ketamine infusion