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Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03302689
Recruitment Status : Unknown
Verified October 2017 by Alexandr Ronenson, Tver Regional Perinatal Center.
Recruitment status was:  Active, not recruiting
First Posted : October 5, 2017
Last Update Posted : October 25, 2017
Sponsor:
Information provided by (Responsible Party):
Alexandr Ronenson, Tver Regional Perinatal Center

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

Condition or disease Intervention/treatment Phase
Pain, Postoperative Drug: Levobupivacaine Solution Drug: Ropivacaine Solution Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Two groups of women after cesarean section under spinal anesthesia
Masking: Double (Participant, Investigator)
Masking Description: Women after the operation do not know what drug they injected with TAP-block The researcher does not know what type of drug is injected
Primary Purpose: Treatment
Official Title: The Double-blind, Randomized Controlled Trial: Comparison of Levobupivacaine and Ropivacaine for Postoperative Analgesia TAP-block After Caesarean Section
Actual Study Start Date : September 25, 2017
Actual Primary Completion Date : October 23, 2017
Estimated Study Completion Date : January 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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 Name: Rop

Experimental: Levobupivacaine
TAP-block with Levobupivacaine Solution
Drug: Levobupivacaine Solution
TAP-block with Levobupivacaine 0,3% - 25 ml from each side
Other Name: Levo




Primary Outcome Measures :
  1. Level of pain [ Time Frame: 12 hours ]
    Measurement of pain on a VAS scale (from 0 to 10 points)


Secondary Outcome Measures :
  1. The need for additional analgesics (Paracetamol, Tramadol) [ Time Frame: 12 hours ]
    Paracetamol IV infusion 100 ml with VAS = 4 score, Tramadol 5% - 2 ml IM with VAS = 5 scores



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03302689


Locations
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Russian Federation
Tver Regional Perinatal Center
Tver, Russian Federation
Sponsors and Collaborators
Alexandr Ronenson

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Responsible Party: Alexandr Ronenson, Head of department of Anaesthesiology and Intensive Care Unit, Tver Regional Perinatal Center
ClinicalTrials.gov Identifier: NCT03302689    
Other Study ID Numbers: LeRoTAP
First Posted: October 5, 2017    Key Record Dates
Last Update Posted: October 25, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alexandr Ronenson, Tver Regional Perinatal Center:
TAP-block
VAS of pain
Cesarean section
Postoperative analgesia
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Levobupivacaine
Pharmaceutical Solutions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents