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Uncertain safety of one of the study medications.
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Epidurally administered Depodur provides equal or superior analgesia as an epidural infusion of fentanyl for the first 48 hours after a cesarean section.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Epidural Depodur after spinal bupivacaine |
|
| 2 | Active Comparator | Epidural fentanyl infusion after epidural lidocaine or spinal bupivacaine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Depodur | Drug | Depodur 10mg given epidurally at end of cesarean section. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Degree of analgesia (measured on a 10-point scale) | 48 hours post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of minor side effects, such as pruritis or nausea. | 48 hours postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Case Medical Center | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15781537 | Background | Carvalho B, Riley E, Cohen SE, Gambling D, Palmer C, Huffnagle HJ, Polley L, Muir H, Segal S, Lihou C, Manvelian G; DepoDur Study Group. Single-dose, sustained-release epidural morphine in the management of postoperative pain after elective cesarean delivery: results of a multicenter randomized controlled study. Anesth Analg. 2005 Apr;100(4):1150-1158. doi: 10.1213/01.ANE.0000149544.58230.FF. | |
| 17578973 |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Depodur |
| Drug |
Depodur 10mg given epidurally at end of cesarean section after patient received spinal bupivacaine at the beginning of the case. |
|
| Fentanyl | Drug | Epidural fentanyl infusion started after spinal bupivacaine used for the cesarean section. |
|
| Background |
| Carvalho B, Roland LM, Chu LF, Campitelli VA 3rd, Riley ET. Single-dose, extended-release epidural morphine (DepoDur) compared to conventional epidural morphine for post-cesarean pain. Anesth Analg. 2007 Jul;105(1):176-83. doi: 10.1213/01.ane.0000265533.13477.26. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |