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NCT Number: NCT01828840

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

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.

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Key information

Conditions

Post Laparotomy Pain Treatment Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hadassah Medical Organization

Jerusalem, 91120, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

epidural morphine via PCEA

Drug

epidural fentanyl via PCEA

Drug

epidural methadone via PCEA

Drug

intravenous morphine via PCA

Drug

Primary outcomes

  1. 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

  2. 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

  3. patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline

    Time frame: 72 hours post operatively

Secondary outcomes

  1. 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

  2. Pupillometry as compared to baseline

    Time frame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery

  3. 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

  4. Nasal capnography at rest as compared to baseline

    Time frame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Hadassah Medical Organization

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 11, 2013
Registry last updated
Mar 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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