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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03302689

Enrollment

Registered

2017-10-05

Start date

2017-09-25

Completion date

2018-01-01

Last updated

2017-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain, Postoperative

Keywords

TAP-block, VAS of pain, Cesarean section, Postoperative analgesia

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

Interventions

DRUGLevobupivacaine Solution

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

DRUGRopivacaine Solution

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, 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

Intervention model description

Two groups of women after cesarean section under spinal anesthesia

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Level of pain	12 hours	Measurement of pain on a VAS scale (from 0 to 10 points)

Secondary

Measure	Time frame	Description
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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026