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

Not Applicable

Completed

• Conditions: Post Laparotomy Pain Treatment
• Interventions: Drug: epidural morphine via PCEA; Drug: epidural fentanyl via PCEA; Drug: epidural methadone via PCEA; Drug: intravenous morphine via PCA

• Registration Number: NCT01828840
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2013-01-13
• Study First Submitted QC: 2013-04-08
• Study First Posted: 2013-04-11
• Study Start: 2014-04
• Status Verified: 2016-03
• Primary Completion: 2016-12-01
• Study Completion: 2016-12-01
• Last Update Submitted: 2022-03-20
• Last Update Posted: 2022-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
morphine, epidural	epidural morphine via PCEA	Epidurally administrated morphine
fentanyl, epidural	epidural fentanyl via PCEA	epidurally administrated fentanyl
methadone, epidural	epidural methadone via PCEA	epidurally administrated methadone
morphine, intervenous	intravenous morphine via PCA	intravenously administrated morphine

Primary Outcome Measures

Name	Time	Method
Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline	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.	72 hours post operatively
patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline	72 hours post operatively

Secondary Outcome Measures

Name	Time	Method
Measurement of opioid concentration in plasma as compared to baseline	Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Pupillometry as compared to baseline	Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Respiratory rate as compared to baseline	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	Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Report of adverse effects' severity as compared to baseline	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	Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel