Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery

Study Overview
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Brief Summary
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This is a randomized, double-blind, controlled clinical trial is to evaluate the duration of efficacy of parasternal blocks with the use of local anesthetic adjuncts for analgesia after coronary artery bypass grafting surgery.

Detailed Description
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This study will randomize patients to either standard pain control protocols or parasternal blocks after coronary artery bypass grafting-only surgery. This study will specifically examine the effectiveness and duration of analgesia of parasternal blocks with local anesthetic adjuncts, Dexamethasone 10mg and Dexmedetomidine 50mcg, added to the local anesthetic mixture

Official Title
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Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery: A Randomized, Controlled, Double-Blinded Clinical Trial

Conditions
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Coronary Artery Bypass Graft Surgery

Intervention / Treatment
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* Drug: Parasternal blocks
* Drug: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients coming for elective and urgent coronary artery bypass (CABG)-only surgery. Exclusion Criteria: Patients with a history of regular opioid use. Patients with a history of chronic pain. Patients unable to provide consent.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Patients will receive bilateral parasternal blocks at the end of cardiac surgery. | Drug: Parasternal blocks<br>* Parasternal block with Bupivacaine 0.25% + Epinephrine 1:200,000 x 60cc + Dexamethasone 5mg and Dexmedetomidine 50mcg<br>* Other names: pecto-intercostal fascial blocks;|
| Placebo Comparator: Control group<br>Patients will receive all standard care as per the hospital protocols. | Drug: Standard of care<br>* All standard management of postoperative pain, as per local protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain with inspirometry at 24 hours after surgery | Visual analog scale (VAS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to no pain and 10 is equal to the worst imaginable pain | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | Amount of opioid administered (mg of Dilaudid) | 12, 24 and 48 hours after surgery | 
| Amount of rescue analgesia administered | Amount of ketorolac or ketamine administered | Total in the first 48 hours after surgery | 
| Pain score at rest | Visual analog scale (VAS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to no pain and 10 is equal to the worst imaginable pain | 12, 24 and 48 hours after surgery | 
| Pain score with inspirometry | Visual analog scale (VAS) pain score from the sternotomy site during inspirometry. The VAS score is a scale from 0 to 10 where 0 is equivalent to no pain and 10 is equal to the worst imaginable pain | 12 and 48 hours after surgery | 
| Intensive Care Unit (ICU) Length of Stay | Time spent in the intensive care unit after surgery (days) | From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study | 
| Hospital Length of Stay | Time spent in the hospital after surgery (days) | From the date of surgery up until discharge from hospital, followed from the date of surgery up until 6 months after the completion of the study | 
| Inspirometry | Volume inspired on inspirometry | 24 hours after surgery | 
| Patient satisfaction with pain control | 0 extremely unsatisfied to 10 extremely satisfied | at 48 hours after surgery | 
| Mobilization | Time from ICU arrival to the first mobilization to a chair | From ICU arrival until first mobilization (approximately first 48 hours postoperatively) | 
| Ambulation | Time from ICU arrival to the first mobilization to a chair | From ICU arrival until first ambulation (approximately first 72 hours postoperatively) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac surgery, Pain