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

Condition(s) targeted: Post Laparotomy Pain Treatment

Intervention: epidural morphine via PCEA (Drug); epidural fentanyl via PCEA (Drug); epidural methadone via PCEA (Drug); intravenous morphine via PCA (Drug)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Hadassah Medical Organization

Overall contact:
Hadas Lemberg, Phd, Phone: 0097226777572, Email: lhadas@hadassah.org.il

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.

Official title: A Prospective Double Blind Randomized Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

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

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.

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

Secondary outcome:

Measurement of opioid concentration in plasma as compared to baseline

Pupillometry as compared to baseline

Respiratory rate as compared to baseline

Nasal capnography at rest as compared to baseline

Report of adverse effects' severity as compared to baseline

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

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Hadas Lemberg, Phd, Phone: 0097226777572, Email: lhadas@hadassah.org.il

Hadassah Medical Organization, Jerusalem 91120, Israel; Not yet recruiting
Hadas Lemberg, Phd, Phone: 972507874098, Email: lhadas@hadassah.org.il
Elyad Davidson, MD, Phone: 972507874098, Email: Edavidson@hadassah.org.il
Elyad Davidson, MD, Principal Investigator

Starting date: April 2013
Last updated: April 8, 2013