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Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section

NCT ID: NCT03302689

Last Updated: 2017-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-25

Study Completion Date

2018-01-01

Brief Summary

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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

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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

Conditions

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Pain, Postoperative

Keywords

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TAP-block VAS of pain Cesarean section Postoperative analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Two groups of women after cesarean section under spinal anesthesia
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators
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

Study Groups

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Ropivacaine

TAP-block with Ropivacaine Solution

Group Type EXPERIMENTAL

Ropivacaine Solution

Intervention Type DRUG

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

Levobupivacaine

TAP-block with Levobupivacaine Solution

Group Type EXPERIMENTAL

Levobupivacaine Solution

Intervention Type DRUG

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

Interventions

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Levobupivacaine Solution

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

Intervention Type DRUG

Ropivacaine Solution

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

Intervention Type DRUG

Other Intervention Names

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Levo Rop

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandr Ronenson

OTHER

Sponsor Role lead

Responsible Party

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Alexandr Ronenson

Head of department of Anaesthesiology and Intensive Care Unit

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Tver Regional Perinatal Center

Tver', , Russia

Site Status

Countries

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Russia

Other Identifiers

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LeRoTAP

Identifier Type: -

Identifier Source: org_study_id