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Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine for postoperative analgesia using TAP-block
Objectives:
For TAP-block was used Hirokain® (Levobupivacaine) . Injectable solution 7.5 mg / ml; ampoule polypropylene 10 ml, a pack of cardboard 10; No. ЛП-003106, 2015-07-21 to 2020-07-21 from EbbVi Ltd. (Russia); manufacturer: Kurida AS (Norway); Packer: AbbVi S.r.l. (Italy), or Ropivacaine Kabi (Ropivacaine Kabi) (Ropivacaine) Solution for injection 7.5 mg / ml; ampoule polypropylene 1 10 ml, a pack of cardboard 5; EAN code: 4607085481524; No. ЛП-002897, 2015-03-04 to 2020-03-04 from Fresenius Kabi Deutschland GmbH (Germany); manufacturer: Fresenius Kabi Norge (Norway).
Both preparations were diluted to a volume of 50 ml, at a concentration of 3 mg / ml.
It was performed by TAP-block in-plain with a 22G needle Quincke, on both sides, and 25 ml on each side was injected.
The pain syndrome was assessed with admission, and every 2 hours during the first 12 hours after the operation, using a digital scale on the VAS.
All patients received NSAIDs (Ketorol 3 mg IV every 6 hours from admission)
Additionally:
Paracetamol IV infusion 100 ml with VAS = 4 score, lockout time 6 hours Tramadol 5% - 2 ml IM with VAS = or > 5 score, lockout time 6 hours
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ropivacaine | Experimental | TAP-block with Ropivacaine Solution |
|
| Levobupivacaine | Experimental | TAP-block with Levobupivacaine Solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Levobupivacaine Solution | Drug | TAP-block with Levobupivacaine 0,3% - 25 ml from each side |
|
| Measure | Description | Time Frame |
|---|---|---|
| Level of pain | Measurement of pain on a VAS scale (from 0 to 10 points) | 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The need for additional analgesics (Paracetamol, Tramadol) | Paracetamol IV infusion 100 ml with VAS = 4 score, Tramadol 5% - 2 ml IM with VAS = 5 scores | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tver Regional Perinatal Center | Tver' | Russia |
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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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Two groups of women after cesarean section under spinal anesthesia
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Women after the operation do not know what drug they injected with TAP-block The researcher does not know what type of drug is injected
| Ropivacaine Solution | Drug | TAP-block with Ropivacaine 0,3% - 25 ml from each side |
|
|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |