A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2009 by Hadassah Medical Organization.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00848419
First received: February 19, 2009
Last updated: NA
Last verified: February 2009
History: No changes posted
  Purpose

The aims of this study are to provide pharmacokinetic-pharmacodynamic data to quantify the analgesic and side effect profiles of epidural methadone, fentanyl and morphine. The investigators will compare the analgesic effect at three dermatomes to assess the rostral spread of drug, the investigators will assess plasma levels to assess the systemic redistribution of drug and the investigators will assess surrogate markers of central opiate effects (nasal capnography and pupilometry). The investigators hypothesize that due to the long-duration of action of methadone, and its intermediate lipophilicity, that methadone will provide a predominantly segmental analgesia of long duration of action, with low rostral spread and low direct central depressant effects (including respiratory depression).


Condition Intervention Phase
Pain
Drug: Epidural administration of bolus
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective Randomized Comparison of Fentanyl, Methadone and Morphine for Epidural Analgesia in an Experimental Pain Model

Resource links provided by NLM:


Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Change in heat pain tolerance from baseline (using QST Medoc) [ Time Frame: At intervals: 30, 60, 90, 120, 180, 240, 300, 360, 410 min following drug and 24 hours following drug. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in electrical pain tolerance from baseline [ Time Frame: At same time intervals as primary outcome ] [ Designated as safety issue: No ]
  • Plasma concentration of methadone, fentanyl, morphine (and metabolites) [ Time Frame: At each of the time intervals as for primary endpoint ] [ Designated as safety issue: No ]
  • Pupilometry [ Time Frame: At each of the time intervals as primary endpoint ] [ Designated as safety issue: No ]
  • Respiratory rate and arterial CO2 tension [ Time Frame: At each of the time intervals as primary endpoint ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: April 2009
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Methadone
Epidural methadone bolus 4mg
Drug: Epidural administration of bolus
Active Comparator: Morphine
Epidural morphine 4mg bolus
Drug: Epidural administration of bolus
Active Comparator: Fentanyl
Epidural fentanyl 200 microgram bolus
Drug: Epidural administration of bolus
Placebo Comparator: Saline
Epidural saline bolus
Drug: Epidural administration of bolus

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients (men and women) scheduled for extracorporeal shock wave lithotrypsy (for nephrolithiasis) under regional anesthesia.

Exclusion Criteria:

  • Inability to understand consent form; poor communication Refusal to sign consent form Contraindication to regional anesthesia Chronic opioid administration ASA classification 3 or greater Age < 18 or > 70
  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.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Dr Elyad Davidson, Director, Pain Unit, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT00848419     History of Changes
Other Study ID Numbers: Exp pain 1-ginosar-HMO-CTIL
Study First Received: February 19, 2009
Last Updated: February 19, 2009
Health Authority: Israel: Ministry of Health

Keywords provided by Hadassah Medical Organization:
Epidural
Analgesia
Methadone
Morphine
Pharmacokinetic-pharmacodynamic
Experimental pain - analgesic response

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

ClinicalTrials.gov processed this record on October 23, 2014