A Prospective Double Blind Randomized Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia.
Overview
- Phase
- Not Applicable
- Intervention
- epidural morphine via PCEA
- Conditions
- Post Laparotomy Pain Treatment
- Sponsor
- Hadassah Medical Organization
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
morphine, epidural
Epidurally administrated morphine
Intervention: epidural morphine via PCEA
fentanyl, epidural
epidurally administrated fentanyl
Intervention: epidural fentanyl via PCEA
methadone, epidural
epidurally administrated methadone
Intervention: epidural methadone via PCEA
morphine, intervenous
intravenously administrated morphine
Intervention: intravenous morphine via PCA
Outcomes
Primary Outcomes
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
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
patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline
Time Frame: 72 hours post operatively
Secondary Outcomes
- 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)