A Prospective Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia

Hadassah Medical Organization100 enrolled

Overview

The current study aim is to compare between the opioids morphine, fentanyl and methadone in terms of efficacy and side effects profile when administered epidurally for pain management after laparotomies. Intravenous morphine will also be used. The outcomes of that method will be compared to those obtained using epidurally administered opioids, as this is another commonly used postoperative pain relief method.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

100

Conditions

Post Laparotomy Pain Treatment

Interventions

epidural morphine via PCEADRUG

epidural fentanyl via PCEADRUG

epidural methadone via PCEADRUG

intravenous morphine via PCADRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: \* Elective laparotomy Exclusion Criteria: * Subjects with diabetes mellitus, other neurological or systemic disease associated with altered sensory perception * Illicit drug abusers * Chronic use of pain medication * Inability to understand consent form * Age \< 18 * Renal failure (Clcr\<50 ml/min) * Chronic use of drugs that can alter plasma levels and\\or effect of the study drugs * Corrected Q-T interval(QTc)=450msc and above * Contra-indication for epidural catheter insertion * Pregnancy

Locations (1)

Hadassah Medical Organization

Jerusalem, Israel

Outcomes

Primary Outcomes

Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline

Time frame: 72 hours post operatively

Fixed stimuli, variable response: measurement of reaction to fixed temperature by visual analog scale (VAS) as well as Variable stimuli, variable response (electrical stimuli)as compared to baseline.

Time frame: 72 hours post operatively

patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline

Time frame: 72 hours post operatively

Secondary Outcomes

Measurement of opioid concentration in plasma as compared to baseline

Time frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery

Pupillometry as compared to baseline

Time frame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery

Respiratory rate as compared to baseline

Time frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery

Nasal capnography at rest as compared to baseline

Time frame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery

Report of adverse effects' severity as compared to baseline

Time frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery

Report of pain severity- at rest, cough and deep breathing as compared to baseline

Data from ClinicalTrials.gov

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