Back to resultsComparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section
Primary Purpose
Pain, Postoperative
Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Levobupivacaine Solution
Ropivacaine Solution
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring TAP-block, VAS of pain, Cesarean section, Postoperative analgesia
Eligibility 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
Sites / Locations
- Tver Regional Perinatal Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Ropivacaine
Levobupivacaine
Arm Description
TAP-block with Ropivacaine Solution
TAP-block with Levobupivacaine Solution
Outcomes
Primary Outcome Measures
Level of pain
Measurement of pain on a VAS scale (from 0 to 10 points)
Secondary Outcome Measures
The need for additional analgesics (Paracetamol, Tramadol)
Paracetamol IV infusion 100 ml with VAS = 4 score, Tramadol 5% - 2 ml IM with VAS = 5 scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03302689
Brief Title
Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section
Official Title
The Double-blind, Randomized Controlled Trial: Comparison of Levobupivacaine and Ropivacaine for Postoperative Analgesia TAP-block After Caesarean Section
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 25, 2017 (Actual)
Primary Completion Date
October 23, 2017 (Actual)
Study Completion Date
January 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Alexandr Ronenson
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Randomized, double-blind, controlled trial: a comparison of Levobupivacaine and Ropivacaine for postoperative analgesia using TAP-block
Objectives:
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
TAP-block, VAS of pain, Cesarean section, Postoperative analgesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups of women after cesarean section under spinal anesthesia
Masking
ParticipantInvestigator
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
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine
Arm Type
Experimental
Arm Description
TAP-block with Ropivacaine Solution
Arm Title
Levobupivacaine
Arm Type
Experimental
Arm Description
TAP-block with Levobupivacaine Solution
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine Solution
Other Intervention Name(s)
Levo
Intervention Description
TAP-block with Levobupivacaine 0,3% - 25 ml from each side
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Solution
Other Intervention Name(s)
Rop
Intervention Description
TAP-block with Ropivacaine 0,3% - 25 ml from each side
Primary Outcome Measure Information:
Title
Level of pain
Description
Measurement of pain on a VAS scale (from 0 to 10 points)
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
The need for additional analgesics (Paracetamol, Tramadol)
Description
Paracetamol IV infusion 100 ml with VAS = 4 score, Tramadol 5% - 2 ml IM with VAS = 5 scores
Time Frame
12 hours
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Tver Regional Perinatal Center
City
Tver
Country
Russian Federation
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section
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