Evaluation of the Effect of Para-sternal Block on Postoperative Respiratory Function After Cardiac Sternotomy Surgery (PARACARD)

Postoperative pain after cardiac surgery is associated with reduced postoperative respiratory function. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. With an incidence of 10% to 25% of cases, pulmonary complications are the second source of postoperative morbidity after cardiac complications; in 2-5% of cases, the dysfunction is severe and leads to significant consequences that can lead to death. It has been shown that postoperative pain after cardiac surgery is associated with a reduction in functional respiratory capacity. There is an association between greater pain and more pronounced decreases in lung volumes postoperatively. The main objective of this study will be to evaluate the impact of locoregional anesthesia by parasternal block analgesic on postoperative respiratory function at D1 postoperatively

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Postoperative Pulmonary Complications; Ultrasound-guided Parasternal Block; Pulmonary Function Testing
• Intervention / Treatment: Drug: parasternal block; Drug: Standard pain management

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Pierre HUETTE, DR; Phone Number: 03 22 08 78 99; Email: huette.pierre@chu-amiens.fr

Study Locations

• France
  • Amiens, France, 80054
    • Recruiting
    • CHU Amiens-Picardie

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients over 18 years of age
• Elective cardiac surgery under CEC with sternotomy
• Written informed consent from the patient.
• Women of childbearing age must have a negative urine HCG pregnancy test.

Exclusion Criteria:

• Thoracotomy approach
• Mini-sternotomy approach
• Opioid drug dependence or chronic opioid drug use
• Chronic benzodiazepine use (respiratory depressant treatment or treatment that may affect postoperative respiratory function)
• Contraindication or allergy to local anesthetics
• Emergency surgery
• Acute infective endocarditis
• Immunosuppressive or steroid treatment (prednisone > 0.5mg/kg/day or equivalent)
• AIDS with CD4 count <200/mm3
• Autoimmune disorder
• Transplant recipient
• Inclusion in another study within the last 30 days.
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: interventional arm; the experimental arm will receive the parasternal block with injection of locoregional anesthesia	Drug: parasternal block; Echo-guided loco-regional anesthesia by bilateral parasternal block in immediate preoperative. The drug used is Ropivacaine 2mg/ml, 0.2%. Injection of 20ml per side, under ultrasound control, after general anaesthesia and before skin incision, and therefore before surgery
Active Comparator: control arm not requiring loco-regional anesthesia.; the control arm will receive a standard treatment, without locoregional anesthesia	Drug: Standard pain management; Standard pain management care involves a multimodal strategy that includes the use of intravenous analgesics. Morphine medications are the mainstay of pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in postoperative forced vital capacity (FVC)	The primary endpoint was the change (reduction) in postoperative forced vital capacity (FVC) between the preoperative measurement and at D1 postoperatively.; "Forced Vital Capacity measured by SPIROLAB spirometry (Appendix).; "Vital capacity is expressed as % of theoretical value.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Variation of FCV between both groups	Respiratory functional investigations at day 2 is forced vital capacity (FVC)	at day 2
Variation of FCV between both groups	Respiratory functional investigations at 1 month is forced vital capacity (FVC)	at 1 month
Variation of FCV between both groups	Respiratory functional investigations at 3 months is forced vital capacity (FVC)	at 3 months
Variation of forced expiratory volume in 1 second (FEV1)	Respiratory functional investigations at day 2 are forced expiratory volume in 1 second (FEV1)	at day 2

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2022
• Primary Completion (Anticipated): July 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: July 28, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 25, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Postoperative pulmonary complications; Cardiac surgery; Ultrasound-guided Parasternal Block; Pulmonary function testing
• Other Study ID Numbers: PI2021_843_0229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No