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Clinical Trial Summary

Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine for postoperative analgesia using TAP-block

Objectives:

1. VAS score during the first 12 hours

2. Determine which drug is more effective for postoperative analgesia in the first 12 hours after surgery

3. Side effects


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03302689
Study type Interventional
Source Tver Regional Perinatal Center
Contact
Status Active, not recruiting
Phase N/A
Start date September 25, 2017
Completion date January 1, 2018

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