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

NCT ID: NCT01828840

Last Updated: 2022-03-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-12-01

Brief Summary

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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.

Detailed Description

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Conditions

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Post Laparotomy Pain Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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morphine, epidural

Epidurally administrated morphine

Group Type ACTIVE_COMPARATOR

epidural morphine via PCEA

Intervention Type DRUG

fentanyl, epidural

epidurally administrated fentanyl

Group Type ACTIVE_COMPARATOR

epidural fentanyl via PCEA

Intervention Type DRUG

methadone, epidural

epidurally administrated methadone

Group Type ACTIVE_COMPARATOR

epidural methadone via PCEA

Intervention Type DRUG

morphine, intervenous

intravenously administrated morphine

Group Type ACTIVE_COMPARATOR

intravenous morphine via PCA

Intervention Type DRUG

Interventions

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epidural morphine via PCEA

Intervention Type DRUG

epidural fentanyl via PCEA

Intervention Type DRUG

epidural methadone via PCEA

Intervention Type DRUG

intravenous morphine via PCA

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0080-10-HMO

Identifier Type: -

Identifier Source: org_study_id

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