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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified January 2013 by Hadassah Medical Organization
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01828840
First received: January 13, 2013
Last updated: April 8, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Post Laparotomy Pain Treatment
Drug: epidural morphine via PCEA
Drug: epidural fentanyl via PCEA
Drug: epidural methadone via PCEA
Drug: intravenous morphine via PCA

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Double Blind Randomized Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia.

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline [ Time Frame: 72 hours post operatively ] [ Designated as safety issue: No ]
  • 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. [ Time Frame: 72 hours post operatively ] [ Designated as safety issue: No ]
  • patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline [ Time Frame: 72 hours post operatively ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measurement of opioid concentration in plasma as compared to baseline [ Time Frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery ] [ Designated as safety issue: No ]
  • Pupillometry as compared to baseline [ Time Frame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery ] [ Designated as safety issue: Yes ]
  • Respiratory rate as compared to baseline [ Time Frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery ] [ Designated as safety issue: Yes ]
  • Nasal capnography at rest as compared to baseline [ Time Frame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery ] [ Designated as safety issue: Yes ]
  • Report of adverse effects' severity as compared to baseline [ Time Frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery ] [ Designated as safety issue: Yes ]
  • Report of pain severity- at rest, cough and deep breathing as compared to baseline [ Time Frame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: morphine, epidural
Epidurally administrated morphine
Drug: epidural morphine via PCEA
Active Comparator: fentanyl, epidural
epidurally administrated fentanyl
Drug: epidural fentanyl via PCEA
Active Comparator: methadone, epidural
epidurally administrated methadone
Drug: epidural methadone via PCEA
Active Comparator: morphine, intervenous
intravenously administrated morphine
Drug: intravenous morphine via PCA

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01828840

Contacts
Contact: Hadas Lemberg, Phd 0097226777572 lhadas@hadassah.org.il

Locations
Israel
Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Hadas Lemberg, Phd    972507874098    lhadas@hadassah.org.il   
Contact: Elyad Davidson, MD    972507874098    Edavidson@hadassah.org.il   
Principal Investigator: Elyad Davidson, MD         
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01828840     History of Changes
Other Study ID Numbers: 0080-10-HMO
Study First Received: January 13, 2013
Last Updated: April 8, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
morphine
fentanyl
methadone
epidural
intravenous
pain
analgesia

Additional relevant MeSH terms:
Methadone
Fentanyl
Morphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on August 18, 2014