Comparison Levobupivacaine and Ropivacaine for TAP-block After Caesarean Section

Pain, Postoperative Clinical Trial

Official title:

The Double-blind, Randomized Controlled Trial: Comparison of Levobupivacaine and Ropivacaine for Postoperative Analgesia TAP-block After Caesarean Section

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03302689
• Other study ID #: LeRoTAP
• Status: Active, not recruiting
• Phase: N/A
• First received: September 26, 2017
• Last updated: October 24, 2017
• Start date: September 25, 2017
• Est. completion date: January 1, 2018

Study information

• Verified date: October 2017
• Source: Tver Regional Perinatal Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: January 1, 2018
• Est. primary completion date: October 23, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Levobupivacaine Solution
TAP-block with Levobupivacaine 0,3% - 25 ml from each side
• Ropivacaine Solution
TAP-block with Ropivacaine 0,3% - 25 ml from each side

Locations

Country	Name	City	State
Russian Federation	Tver Regional Perinatal Center	Tver

Sponsors (1)

Lead Sponsor	Collaborator
Alexandr Ronenson

Country where clinical trial is conducted

Russian Federation, 

Outcome

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