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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-01

Study Completion Date

2014-08-01

Brief Summary

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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.

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Detailed Description

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not desired

Conditions

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Post Operative Pain Hyperalgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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zero/morphine

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

ketamine infusion

Intervention Type DRUG

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

zero/metadone

Methadone PCA

Group Type EXPERIMENTAL

Methadone PCA

Intervention Type DRUG

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

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.).

Group Type EXPERIMENTAL

ketamine infusion

Intervention Type DRUG

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 PCA

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

Methadone PCA

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

Intervention Type DRUG

Other Intervention Names

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hyperalgesia-blocker hyperalgesia-blocker

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No