Trial | NCT03302689  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    50
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
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 Started
Sep 25
2017
Primary Completion
Oct 23
2017
Study Completion
Jan 01
2018
Anticipated
Last Update
Oct 25
2017

Drug Levobupivacaine Solution

TAP-block with Levobupivacaine 0,3% - 25 ml from each side

  • Other names: Levo

Drug Ropivacaine Solution

TAP-block with Ropivacaine 0,3% - 25 ml from each side

  • Other names: Rop

Ropivacaine Experimental

TAP-block with Ropivacaine Solution

Levobupivacaine Experimental

TAP-block with Levobupivacaine Solution

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
No Results Posted