Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section
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|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
Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine for postoperative analgesia using TAP-block
- VAS score during the first 12 hours
- Determine which drug is more effective for postoperative analgesia in the first 12 hours after surgery
- Side effects
|Condition or disease||Intervention/treatment||Phase|
|Pain, Postoperative||Drug: Levobupivacaine Solution Drug: Ropivacaine Solution||Not Applicable|
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)
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 (Clinical Trial)|
|Actual Enrollment :||50 participants|
|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|
|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|
TAP-block with Ropivacaine Solution
Drug: Ropivacaine Solution
TAP-block with Ropivacaine 0,3% - 25 ml from each side
Other Name: Rop
TAP-block with Levobupivacaine Solution
Drug: Levobupivacaine Solution
TAP-block with Levobupivacaine 0,3% - 25 ml from each side
Other Name: Levo
- Level of pain [ Time Frame: 12 hours ]Measurement of pain on a VAS scale (from 0 to 10 points)
- 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
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
|Tver Regional Perinatal Center|
|Tver, Russian Federation|