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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04495504
Other study ID # Pré-BLS-Sterno-RBHP 2018 ELJEZ
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 22, 2020
Est. completion date July 12, 2021

Study information

Verified date December 2022
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date July 12, 2021
Est. primary completion date January 12, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Patients who undergo scheduled cardiac surgery with sternotomy: aortic or mitral valve replacement, biological or mechanical, coronary bypass surgery - Age under 85 years - Patients who have given their consent according to the methods described in Title II of the book of the first Public Health Code - Possession of Social Security insurance. Exclusion Criteria: - Emergency surgery - Approach by thoracotomy - Heart transplant - Aortic dissection - Redo surgery. - Pregnant women - Refusal of the protocol - Protected minors or adults - Pre-existing psychiatric pathology including known states of opioid addiction - Long-term opioid medication - Physical or intellectual inability to use a PCA - Severe heart failure (ejection fraction less than 40% or PAH > 50 mmHg) - Preoperative cardiogenic shock - Severe preoperative chronic or acute renal failure with a creatinine clearance of less than 30 mL / min according to Cockroft's formula - Known hypersensitivity to local anesthetics or to any component of the catheter - Known allergy or hypersensitivity to any of the study drugs or analgesia protocol (ropivacaine, paracetamol, opiates).

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
France CHU Clermont-Ferrand - Service de Chirurgie Cardio-Vasculaire Clermont-Ferrand Puy De Dôme

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain evaluation The technique is considered as a fail if : pain rest > 3.5 /10 (0 = no pain; 10 maximum pain) or pain during mobilization > 3.5/10 (0 = no pain; 10 maximum pain) Day 2 postoperatively.
Primary Opioid consumption The technique is considered as a fail if morphine consumption > 35 mg Day 2 postoperatively.
Secondary ICU length of stay Days of ICU and hospital stay Up to 6 months
Secondary Hospital length of stay Days of ICU and hospital stay Up to 6 months
Secondary Patient satisfaction Patient satisfaction evaluation from the patient based on a simple Likert scale:
0 = very bad; 1 = bad; 2 = medium; 3 = good; 4 = excellent.
Day 2 postoperatively.
Secondary Postoperative nausea and vomiting assessed by the Wengritzky intensity scale (if total score > 50, the nausea and vomiting are clincally significant) Day 1 and 2 postoperatively.
Secondary Respiratory complications Occurrence of postoperative respiratory complications Up to 6 months
Secondary Cardiac complications Occurrence of postoperative cardiac complications Up to 6 months
Secondary Neurological complications Occurrence of postoperative neurological complications Up to 6 months
Secondary Renal,complications Occurrence of postoperative renal complications Up to 6 months
Secondary Infectious complications Occurrence of postoperative infectious complications Up to 6 months
Secondary Chronic pain evaluation Chronic pain assessed at the 6th postoperative month by DN4 (Neuropathic Pain Diagnostic 4) score Assessed at the 6th postoperative month
See also
  Status Clinical Trial Phase
Completed NCT01828788 - Postoperative Rehabilitation After Cardiac Surgery in Patients at Risk of Respiratory Complications. Effects of a Continuous Bi-laterosternal Infusion of Ropivacaine Through Multihole Catheters Phase 2