N/A N=113 Randomized Double-blind Treatment

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

Post Operative Pain · Hyperalgesia

Bottom Line

View on ClinicalTrials.gov: NCT01594047 ↗

Enrolled (actual)

113

Serious AEs

0.0%

Results posted

Oct 2023

Primary outcome: Primary: the Extent of Hyperalgesia Area Proximal to Surgical Wound — 19.5; 14.68; 15.28; 11.04 cm

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ketamine infusion (Drug); Methadone PCA (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Primary completion: Jun 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY the Extent of Hyperalgesia Area Proximal to Surgical Wound	19.5; 14.68; 15.28; 11.04; 16.04; 16.38	—
SECONDARY Pain Intensity Measured by a Numeric Rating Scale (NRS)	1.92; 1.64; 0.61; 0.78; 4.75; 4.68	—
SECONDARY Opioid Consumption	56.09; 66.9; 43.64; 38.96	—

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.

Eligibility 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.

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Data sourced from ClinicalTrials.gov (NCT01594047). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.