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

NCT05515809 | Active Not Recruiting Phase 3

• 1 other identifier: PI2021_843_0229
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Surgery; Ultrasound-guided Parasternal Block; Postoperative Pulmonary Complications; Pulmonary Function Testing

Keywords

Cardiac surgery; Ultrasound-guided Parasternal Block; Postoperative pulmonary complications; Pulmonary function testing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Variation of FCV between both groups

  at day 2

• Variation of FCV between both groups

  at 1 month

• Variation of FCV between both groups

  at 3 months

• Variation of forced expiratory volume in 1 second (FEV1)

  at day 2

Study Arms (2)

interventional arm

EXPERIMENTAL

the experimental arm will receive the parasternal block with injection of locoregional anesthesia

Drug: parasternal block

control arm not requiring loco-regional anesthesia.

ACTIVE COMPARATOR

the control arm will receive a standard treatment, without locoregional anesthesia

Drug: Standard pain management

Interventions

parasternal block DRUG

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

interventional arm

Standard pain management DRUG

Standard pain management care involves a multimodal strategy that includes the use of intravenous analgesics. Morphine medications are the mainstay of pain management

control arm not requiring loco-regional anesthesia.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens-Picardie

Amiens, 80054, France

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2022
• First Posted: August 25, 2022
• Study Start: July 19, 2022
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)