The Double-blind, Randomized Controlled Trial: Comparison of Levobupivacaine and Ropivacaine for Postoperative Analgesia TAP-block After Caesarean Section
Overview
- Phase
- Not Applicable
- Intervention
- Ropivacaine Solution
- Conditions
- Pain, Postoperative
- Sponsor
- Alexandr Ronenson
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Level of pain
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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
Investigators
Alexandr Ronenson
Head of department of Anaesthesiology and Intensive Care Unit
Tver Regional Perinatal Center
Eligibility Criteria
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
Arms & Interventions
Ropivacaine
TAP-block with Ropivacaine Solution
Intervention: Ropivacaine Solution
Levobupivacaine
TAP-block with Levobupivacaine Solution
Intervention: Levobupivacaine Solution
Outcomes
Primary Outcomes
Level of pain
Time Frame: 12 hours
Measurement of pain on a VAS scale (from 0 to 10 points)
Secondary Outcomes
- The need for additional analgesics (Paracetamol, Tramadol)(12 hours)