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| Name | Class |
|---|---|
| Israel Society of Anesthesiologists | UNKNOWN |
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It is unclear whether addition of opioids to epidural solutions for postoperative analgesia is beneficial. In this multicenter randomized double-blinded trial, we aim to test the primary hypothesis that epidural solutions containing only bupivacaine are as effective as solutions containing both bupivacaine and fentanyl in promoting analgesia in patients recovering from open abdominal surgery. We also aim to assess the incidence of epidural-induced hypotension, the difference in patient-reported opioid side-effects between the two groups. If we demonstrate no clinically important difference between the two interventions, clinicians will be able to substantially reduce the amount of opioids patients receive during their postoperative recovery, and potentially decrease the associated high incidence of opioid adverse effects in post-surgical patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bupivacaine | Experimental | Epidural solution containing 0.1% bupivaacaine in normal saline |
|
| Bupivacaine + Fentanyl | Experimental | Epidural solution containing 0.1% bupivacaine and 3 mcg/ml of fentanyl in normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | epidural solution containing bupivacaine 0.1% in normal saline |
|
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative analgesia | A joint outcome of the difference in average pain score and a ratio of opioid consumption (in mg morphine equivalents) between the 2 study groups | 48 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Clinically significant postoperative hypotension | Number of participants experiencing a composite of use of IV fluid boluses prescribed for hemodynamic support; sympathomimetic drugs administration; and holding or early discontinuation of the epidural infusion in order to recover blood pressure. | 48 postoperative hours |
| Measure | Description | Time Frame |
|---|---|---|
| Recovery of gastrointestinal function | Time to first postoperative bowel movement | Throughout the postoperative hospital stay, up to 30 days |
| Opioid-related side effects | A composite of opioid-related side-effects as measured by the Opioid-Related Symptom Distress Scale (OR-SDS) questionnaire (higher scores represent more side-effects and related distress, scores are given on multiple dimensions) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Anesthesia, Pain and Critical Care, Tel-Aviv Sourasky Medical Center | Tel Aviv | Israel |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Fentanyl | Drug | Epidural solution containing fentanyl 3 mcg/ml (in addition to bupivacaine) in normal saline |
|
|
| 48 postoperative hours |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |