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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-19

Study Completion Date

2025-06-30

Brief Summary

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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

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Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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interventional arm

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

Group Type EXPERIMENTAL

parasternal block

Intervention Type 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

control arm not requiring loco-regional anesthesia.

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

Group Type ACTIVE_COMPARATOR

Standard pain management

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No