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

Post Laparotomy Pain Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01828840
• Other study ID #: 0080-10-HMO
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: December 1, 2016

Study information

• Verified date: March 2016
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 1, 2016
• Est. primary completion date: December 1, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Post Laparotomy Pain Treatment

Intervention

Drug:
• epidural morphine via PCEA

• epidural fentanyl via PCEA

• epidural methadone via PCEA

• intravenous morphine via PCA

Locations

Country	Name	City	State
Israel	Hadassah Medical Organization	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline		72 hours post operatively
Secondary	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
Secondary	Pupillometry as compared to baseline		Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Secondary	Respiratory rate as compared to baseline		Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Secondary	Nasal capnography at rest as compared to baseline		Baseline and twice daily for 72 hours starting 18-24 hours post surgery
Secondary	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
Secondary	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