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Clinical Trials/NCT03302689
NCT03302689
Unknown
Not Applicable

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

Alexandr Ronenson1 site in 1 country50 target enrollmentSeptember 25, 2017

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:

  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

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

Registry
clinicaltrials.gov
Start Date
September 25, 2017
End Date
January 1, 2018
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Alexandr Ronenson
Responsible Party
Sponsor Investigator
Principal Investigator

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)

Study Sites (1)

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