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

Hadassah Medical Center

Status: Completed

Conditions: Post Laparotomy Pain Treatment

Treatments: Drug: epidural methadone via PCEA; Drug: epidural fentanyl via PCEA; Drug: epidural morphine via PCEA; Drug: intravenous morphine via PCA

Study type: Interventional

Funder types: Other

Identifiers

NCT01828840

0080-10-HMO

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 4 patient groups

morphine, epidural

Active Comparator group

Description:

Epidurally administrated morphine

Treatment:

Drug: epidural morphine via PCEA

fentanyl, epidural

Active Comparator group

Description:

epidurally administrated fentanyl

Treatment:

Drug: epidural fentanyl via PCEA

methadone, epidural

Active Comparator group

Description:

epidurally administrated methadone

Treatment:

Drug: epidural methadone via PCEA

morphine, intervenous

Active Comparator group

Description:

intravenously administrated morphine

Treatment:

Drug: intravenous morphine via PCA