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| Name | Class |
|---|---|
| Cristália Produtos QuÃmicos Farmacêuticos Ltda. | INDUSTRY |
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The purpose of this study is to determine if bupivacaine (75% levobupivacaine plus 25% racemic bupivacaine) with vasoconstrictor is effective and safety as ropivacaine in brachial plexus block for orthopedic surgery.
The intoxication by Bupivacaine is considered life threatening. Currently the most safety local anesthetic in substitution to bupivacaine is ropivacaine, however in Brasil there is a bupivacaine mixture of 75% levobupivacaine plus 25% racemic bupivacaine. The research design is:
Patients involved: 48; age: 18 to 40 years old; both sex; ASA I and II. Surgery: elective upper extremity orthopedic surgery. Anesthesia technique: brachial plexus block. Primary endpoint: cardiovascular safety; analysis by continuous Holter. Secondary endpoint: anesthetic and analgesic efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Active Comparator | Arm number B corresponds to the Bupivacaine group. |
|
| R | Active Comparator | Arm number R corresponds to the Ropivacaine group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | Dosage: 150mg at once for anesthesia induction |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cardiovascular safety | Two days |
| Measure | Description | Time Frame |
|---|---|---|
| Anesthesia Analgesia quality | Two days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Otávio C Auler Junior, PhD/Chairman | Hospital das ClÃnicas - Medicine School of the University of São Paulo | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12719052 | Background | Casati A, Santorsola R, Aldegheri G, Ravasi F, Fanelli G, Berti M, Fraschini G, Torri G. Intraoperative epidural anesthesia and postoperative analgesia with levobupivacaine for major orthopedic surgery: a double-blind, randomized comparison of racemic bupivacaine and ropivacaine. J Clin Anesth. 2003 Mar;15(2):126-31. doi: 10.1016/s0952-8180(02)00513-5. | |
| 11943523 |
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| ID | Term |
|---|---|
| D006230 | Hand Injuries |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Ropivacaine |
| Drug |
Single dose of ropivacaine, 150mg |
|
| Casati A, Chelly JE, Cerchierini E, Santorsola R, Nobili F, Grispigni C, Di Benedetto P, Torri G. Clinical properties of levobupivacaine or racemic bupivacaine for sciatic nerve block. J Clin Anesth. 2002 Mar;14(2):111-4. doi: 10.1016/s0952-8180(01)00364-6. |
| 12505962 | Background | Casati A, Borghi B, Fanelli G, Montone N, Rotini R, Fraschini G, Vinciguerra F, Torri G, Chelly J. Interscalene brachial plexus anesthesia and analgesia for open shoulder surgery: a randomized, double-blinded comparison between levobupivacaine and ropivacaine. Anesth Analg. 2003 Jan;96(1):253-9, table of contents. doi: 10.1097/00000539-200301000-00051. |
| 11778092 | Background | Santorsola R, Casati A, Cerchierini E, Moizo E, Fanelli G. [Levobupivacaine for peripheral blocks of the lower limb: a clinical comparison with bupivacaine and ropivacaine]. Minerva Anestesiol. 2001 Sep;67(9 Suppl 1):33-6. Italian. |
| 15635515 | Background | Borgeat A, Ekatodramis G, Blumenthal S. Interscalene brachial plexus anesthesia with ropivacaine 5 mg/mL and bupivacaine 5 mg/mL: effects on electrocardiogram. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):557-63. doi: 10.1016/j.rapm.2004.09.005. |
| D000588 |
| Amines |