Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy

Study Overview
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Brief Summary
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The aim of this randomized controlled trial is to examine the effect of ultrasound guided bilateral Parasternal Nerve Block combined with rectus sheath block on preoperative analgesia, opioid consumption and respiratory function in patients undergoing cardiac surgery via sternotomy. Half of participants will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block while the other half receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic (without performing rectus sheath block)

Official Title
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Ultrasound Guided Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy: A Randomized Controlled Trial

Conditions
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Cardiac Disease, Surgery, Analgesia, Acute Pain, Postoperative Pain

Intervention / Treatment
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* Procedure: PARASTERNAL BLOCK
* Procedure: LOCAL INFILTRATION OF DRAINAGE EXIT SITES
* Procedure: RECTUS SHEATH BLOCK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective cardiac surgery under median sternotomy Age >= 18 years American Society of Anesthesiologists (ASA) Status I-IV Approval and sign of the informed consent Exclusion Criteria: Allergy to local anesthetics Puncture site infection Lack of signing of informed consent Age <18 years Emergency surgery ASA > IV preoperative acute respiratory failure

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RECTUS group<br>Patients will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block | Procedure: PARASTERNAL BLOCK<br>* After induction of general anesthesia, an ultrasound-guided Parasternal Block will be performed with 20 mL of ropivacaine 0.5 % per side.<br>Procedure: RECTUS SHEATH BLOCK<br>* At the end of surgery, a rectus sheath block will be performed with 10 mL of ropivacaine 0.25% per side.<br>|
| Active Comparator: CONTROL group<br>Patients will receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic | Procedure: PARASTERNAL BLOCK<br>* After induction of general anesthesia, an ultrasound-guided Parasternal Block will be performed with 20 mL of ropivacaine 0.5 % per side.<br>Procedure: LOCAL INFILTRATION OF DRAINAGE EXIT SITES<br>* At the end of surgery, a local infiltration of drainage exit sites will be performed with 10 mL of ropivacaine 0.25% per side<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Static Pain Score | A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery | 24 hours | 
| Dynamic Pain Score | A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) during movement will be used to evaluate pain at rest during 24 hours after surgery | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative Fentanyl Consumption | Total intravenous fentanyl administration (expressed in milligrams) during surgery | 4 hours | 
| Morphine Consumption | Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery | 24 hours | 
| Time of Extubation | Interval between the end of surgery and patient's extubation | 48 hours | 
| Respiratory performance at incentive spirometry | Respiratory performance is assessed preoperatively and postoperatively (at extubation) by the number of balls raised during inspiration with the TRI-FLOW spirometer | 48 hours | 
| Intensive Care Unit (ICU) Discharge Time | Interval between patient arrival in ICU and discharge from ICU | 120 hours | 
| Hospitalization Length of Stay | Total Hospital length of Stay (expressed in days) | 30 days | 
| Incidence of adverse events | Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity. Moreover, incidence of nausea, vomiting and postoperative respiratory complications will be recorded. | 24 hours |