An interventional study of Levobupivacaine Solution and Ropivacaine Solution in Pain, Postoperative, sponsored by Alexandr Ronenson. Status unknown at 1 site in Russian Federation. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-25.
Sponsored by Alexandr Ronenson · Not applicable, Interventional, and Treatment
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
Exclusion Criteria:
TAP-block with Ropivacaine Solution
Drug: Ropivacaine Solution
TAP-block with Levobupivacaine Solution
Drug: Levobupivacaine Solution
TAP-block with Levobupivacaine 0,3% - 25 ml from each side
Also known as: Levo
TAP-block with Ropivacaine 0,3% - 25 ml from each side
Also known as: Rop
Level of pain
Measurement of pain on a VAS scale (from 0 to 10 points)
Time frame: 12 hours
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
Time frame: 12 hours
Plan to share: No
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