Erector Spinae Plane Block Versus Paravertebral Block for Analgesic Outcomes After Cardiac Surgery (PEPS): a Prospective Randomized Comparative Study.

Status: Completed
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The purpose of this randomized double-blind study is to compare the analgesic efficacy of the bilateral Erector Spinae Plane (ESP) block versus the bilateral Thoracic Paravertebral block (TPVB), by ultrasound-guided single injection in patients who underwent sternotomy for cardiac surgery.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Undergoing any (scheduled) surgery of the heart (valve or coronary surgery) via a median sternotomy

• Physical status classification (ASA) ≤3

• Patients benefiting from a Social Security scheme or benefiting from it through a third party

Locations
Other Locations
France
Institut Mutualiste montsouris
Paris
Time Frame
Start Date: 2021-01-07
Completion Date: 2023-11-02
Participants
Target number of participants: 96
Treatments
Active_comparator: Paravertebral Block
If the patient is randomized to group Paravertebral Block, the anesthesiologist performs TPVB after induction of general anesthesia. The patient is positioned in lateral decubitus position. The anesthetist performs the bilateral paravertebral block with ultrasound identification of the paravertebral space at the T4-T5 level. Slow injection of 0.3 to 0.35 ml / kg of ropivacaine on each side (diluted to 3.75 mg / ml = dilution in a 20 ml syringe with 10 ml of ropivacaine 7.5 mg / ml and 10 ml of NaCl 0.9%) after aspiration test.
Experimental: Erector Spinae Plane Block
If the patient is randomized to group Erector Spinae Plane Block, the anesthesiologist performs the ESPb block after induction of general anesthesia. The patient is positioned in a right lateral decubitus position. The anesthesiologist performs the erector block of the spine ESP with ultrasound identification at the T4-T5 level (identify the 1st rib on ultrasound then the space T4 to T5). Slow injection of 20 ml of ropivacaine on each side (diluted to 3.75 mg / ml = dilution in a 20 ml syringe with 10 ml of ropivacaine 7.5 mg / ml and 10 ml of 0.9% NaCl) after aspiration test.~The patient is then turned in left lateral decubitus position and the contralateral block is performed according to the same procedure.
Authors
Fehmi Kattou
Related Therapeutic Areas
Sponsors
Leads: Institut Mutualiste Montsouris
Collaborators: Fondation Ophtalmologique Adolphe de Rothschild

This content was sourced from clinicaltrials.gov

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