Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section

Study Overview
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Brief Summary
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Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine for postoperative analgesia using TAP-block Objectives: VAS score during the first 12 hours Determine which drug is more effective for postoperative analgesia in the first 12 hours after surgery Side effects

Detailed Description
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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

Official Title
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The Double-blind, Randomized Controlled Trial: Comparison of Levobupivacaine and Ropivacaine for Postoperative Analgesia TAP-block After Caesarean Section

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Levobupivacaine Solution
* Drug: Ropivacaine Solution


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cesarean section pfannenstiel incision under spinal anesthesia Spinal anesthesia with Bupivacaine heavy 0,5% Without any adjuvants Exclusion Criteria: Any other anesthesia exept spinal Any other surgical incision
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Two groups of women after cesarean section under spinal anesthesia
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ropivacaine<br>TAP-block with Ropivacaine Solution | Drug: Ropivacaine Solution<br>* TAP-block with Ropivacaine 0,3% - 25 ml from each side<br>* Other names: Rop;|
| Experimental: Levobupivacaine<br>TAP-block with Levobupivacaine Solution | Drug: Levobupivacaine Solution<br>* TAP-block with Levobupivacaine 0,3% - 25 ml from each side<br>* Other names: Levo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of pain | Measurement of pain on a VAS scale (from 0 to 10 points) | 12 hours | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TAP-block, VAS of pain, Cesarean section, Postoperative analgesia