Clinical trial NCT01828840: A Prospective Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia
Official title: A Prospective Double Blind Randomized Comparison of Methadone, Fentanyl, and Morphine for Post-laparotomy Epidural Analgesia.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Laparotomy Pain Treatment
Keywords: morphine
fentanyl
methadone
epidural
intravenous
pain
analgesia
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2013-04-11
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline
timeFrame: 72 hours post operatively
measure: 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.
timeFrame: 72 hours post operatively
measure: patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline
timeFrame: 72 hours post operatively
Secondary outcomes:
measure: Measurement of opioid concentration in plasma as compared to baseline
timeFrame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
measure: Pupillometry as compared to baseline
timeFrame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery
measure: Respiratory rate as compared to baseline
timeFrame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
measure: Nasal capnography at rest as compared to baseline
timeFrame: Baseline and twice daily for 72 hours starting 18-24 hours post surgery
measure: Report of adverse effects' severity as compared to baseline
timeFrame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
measure: Report of pain severity- at rest, cough and deep breathing as compared to baseline
timeFrame: Baseline, 4 hours post surgery and twice daily for 72 hours starting 18-24 hours post surgery
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
References: