Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section

Alexandr Ronenson

Status: Unknown

Conditions: Pain, Postoperative

Treatments: Drug: Ropivacaine Solution; Drug: Levobupivacaine Solution

Study type: Interventional

Funder types: Other

Identifiers

NCT03302689

LeRoTAP

Details and patient eligibility

About

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

Full 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

Enrollment: 50 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Ropivacaine

Experimental group

Description:

TAP-block with Ropivacaine Solution

Treatment:

Drug: Ropivacaine Solution

Levobupivacaine

Experimental group

Description:

TAP-block with Levobupivacaine Solution

Treatment:

Drug: Levobupivacaine Solution