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

Not Applicable

Completed

• Conditions: Post Operative Pain; Hyperalgesia
• Interventions: Drug: ketamine infusion; Drug: Methadone PCA

• Registration Number: NCT01594047
• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

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 Timeline

• Study Start: 2009-12-01
• Study First Submitted: 2012-05-05
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-08
• Primary Completion: 2012-06-01
• Study Completion: 2014-08-01
• Results First Submitted: 2018-02-27
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-17
• Last Update Submitted: 2023-01-17
• Results First Posted: 2023-10-02
• Last Update Posted: 2023-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 113

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ketamine/morphine	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.
zero/metadone	Methadone PCA	Methadone PCA
ketamine/methadone	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. Methadone administered by a PCA system (dose 2 mg, lock-out 12min.).
ketamine/methadone	Methadone PCA	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.).

Primary Outcome Measures

Name	Time	Method
the Extent of Hyperalgesia Area Proximal to Surgical Wound	24 and 48 hours after surgery	Hyperalgesia is determined by stimulating with a won Fray hair N°16 along three lines at a right angle to the top, middle, and bottom sides of the surgical incision. Each line starts from the edge of the abdomen to the surgical incision.; Stimulation continue from the edge toward the surgical incision until the patients reported a worsening in sensation The distance from the incision to where sensation change was measured. The mean of the three assessments was used as a measure of the extent of the hyperalgesia area.

Secondary Outcome Measures

Name	Time	Method
Pain Intensity Measured by a Numeric Rating Scale (NRS)	24 and 48 hours after surgery	A Numerical Rating Scale (NRS) from 0 to 10 is used as a measure of pain intensity. Zero indicates the absence of any pain and 10 the worse pain never felt.
Opioid Consumption	48 hours	Cumulative opioid consumption at 48 hours from surgery ( end of the study)

Trial Locations

Locations (1)

Fondazione IRCCS Istituto Nazionale dei Tumori; 🇮🇹 Milano, Italy