Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section

Not Applicable

• Conditions: Pain, Postoperative
• Interventions: Drug: Ropivacaine Solution; Drug: Levobupivacaine Solution

• Registration Number: NCT03302689
• Lead Sponsor: Alexandr Ronenson

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

Study Timeline

• Study Start: 2017-09-25
• Study First Submitted: 2017-09-26
• Status Verified: 2017-10
• Study First Submitted QC: 2017-10-04
• Study First Posted: 2017-10-05
• Primary Completion: 2017-10-23
• Last Update Submitted: 2017-10-24
• Last Update Posted: 2017-10-25
• Study Completion: 2018-01-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine	Ropivacaine Solution	TAP-block with Ropivacaine Solution
Levobupivacaine	Levobupivacaine Solution	TAP-block with Levobupivacaine Solution

Primary Outcome Measures

Name	Time	Method
Level of pain	12 hours	Measurement of pain on a VAS scale (from 0 to 10 points)

Secondary Outcome Measures

Name	Time	Method
The need for additional analgesics (Paracetamol, Tramadol)	12 hours	Paracetamol IV infusion 100 ml with VAS = 4 score, Tramadol 5% - 2 ml IM with VAS = 5 scores

Trial Locations

Locations (1)

Tver Regional Perinatal Center; 🇷🇺 Tver, Russian Federation