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

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

Study Overview

• Status: Unknown
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Ropivacaine Solution; Drug: Levobupivacaine Solution

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Tver, Russian Federation
    • Tver Regional Perinatal Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Alexandr Ronenson

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): October 23, 2017
• Study Completion (Anticipated): January 1, 2018

Study Registration Dates

• First Submitted: September 26, 2017
• First Submitted That Met QC Criteria: October 4, 2017
• First Posted (Actual): October 5, 2017

Study Record Updates

• Last Update Posted (Actual): October 25, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: Cesarean section; Postoperative analgesia; TAP-block; VAS of pain
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Pharmaceutical Solutions; Ropivacaine; Levobupivacaine
• Other Study ID Numbers: LeRoTAP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No