NCT04495504

Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

The Effect of Continuous Administration of Ropivacaine by Bi-laterosternal Multiperforated Catheters Placed Before a Sternotomy for Cardiac Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: University Hospital, Clermont-Ferrand · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

The sternotomy site is the most painful site after cardiac surgery. Local infiltration of ropivacaine through the multihole catheters in the bilaterosternal position (BLS) after sternotomy significantly reduces pain at rest and during mobilization, reduces opioids consumption, decreases postoperative complications, improves patient comfort and satisfaction and reduced hospital costs. In this study our hypothesis is to test the efficacity of local anesthetic administration via the catheters in the BLS position placed before the surgical incision.

Detailed description

Goal of the study: Evaluation of the effectiveness of BLS technique on a composite endpoint (pain at rest, pain during patient mobilization and opioid consumption). Open trial, therapeutic, prospective, monocentric. One group of patients who will benefits from the placement of two multihole catheters in BLS position: * The ropivacaine group (40 patients): placement by the surgeon of two catheters in BLS position before the surgical incision. Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter followed by a continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively. * The control group (80 patients) from the two previous studies who underwent standard analgesia with PCA morphine.

Conditions

• Scheduled Cardiac Surgery
• Age Under 85 Years

Interventions

Type	Name	Description
DRUG	Ropivacaine	Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter Continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.

Timeline

• Start date: 2020-07-22
• Primary completion: 2021-01-12
• Completion: 2021-07-12
• First posted: 2020-08-03
• Last updated: 2022-12-05

Locations

1 site across 1 country: France