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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| morphine, epidural | Active Comparator | Epidurally administrated morphine |
|
| fentanyl, epidural | Active Comparator | epidurally administrated fentanyl |
|
| methadone, epidural | Active Comparator | epidurally administrated methadone |
|
| morphine, intervenous | Active Comparator | intravenously administrated morphine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| epidural morphine via PCEA | Drug |
| ||
| epidural fentanyl via PCEA |
| Measure | Description | Time Frame |
|---|---|---|
| Variable stimuli, fixed response: measurement of pain tolerance by gradual increase of temperature (quantitative sensory testing (QST))as compared to baseline | 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. | 72 hours post operatively | |
| patient controlled epidural analgesia (PCEI)/patient controlled analgesia (PCA)dose frequency as compared to baseline | 72 hours post operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
* Elective laparotomy
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hadassah Medical Organization | Jerusalem | 91120 | Israel |
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| Drug |
|
| epidural methadone via PCEA | Drug |
|
| intravenous morphine via PCA | Drug |
|
| 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 |
| ID | Term |
|---|---|
| D010146 | Pain |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
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