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Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery

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ClinicalTrials.gov Identifier: NCT05191745
Recruitment Status : Recruiting
First Posted : January 13, 2022
Last Update Posted : May 3, 2022
Sponsor:
Information provided by (Responsible Party):
Matthew Cameron, Jewish General Hospital

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Artery Bypass Graft Surgery Drug: Parasternal blocks Drug: Standard of care Phase 3

Detailed Description:
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
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery: A Randomized, Controlled, Double-Blinded Clinical Trial
Actual Study Start Date : January 26, 2022
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Pain with inspirometry at 24 hours after surgery [ Time Frame: 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"


Secondary Outcome Measures :
  1. Opioid consumption [ Time Frame: 12, 24 and 48 hours after surgery ]
    Amount of opioid administered (mg of Dilaudid)

  2. Amount of rescue analgesia administered [ Time Frame: Total in the first 48 hours after surgery ]
    Amount of ketorolac or ketamine administered

  3. Pain score at rest [ Time Frame: 12, 24 and 48 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"

  4. Pain score with inspirometry [ Time Frame: 12 and 48 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"

  5. Intensive Care Unit (ICU) Length of Stay [ Time Frame: From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study ]
    Time spent in the intensive care unit after surgery (days)

  6. Hospital Length of Stay [ Time Frame: 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 ]
    Time spent in the hospital after surgery (days)

  7. Inspirometry [ Time Frame: 24 hours after surgery ]
    Volume inspired on inspirometry

  8. Patient satisfaction with pain control [ Time Frame: at 48 hours after surgery ]
    0 "extremely unsatisfied" to 10 "extremely satisfied"

  9. Mobilization [ Time Frame: From ICU arrival until first mobilization (approximately first 48 hours postoperatively) ]
    Time from ICU arrival to the first mobilization to a chair

  10. Ambulation [ Time Frame: From ICU arrival until first ambulation (approximately first 72 hours postoperatively) ]
    Time from ICU arrival to the first mobilization to a chair


Other Outcome Measures:
  1. Presence of postoperative vomiting [ Time Frame: first 48 hours after surgery ]
    Vomiting after surgery

  2. Incidence of bradycardia [ Time Frame: first 48 hours after surgery ]
    Heart rate less than 60 beats per minute

  3. Incidence of hyperglycemia [ Time Frame: first 48 hours after surgery ]
    Glucose greater than 10 millimoles/liter

  4. Incidence of a pneumothorax [ Time Frame: first 48 hours after surgery ]
    Pneumothorax identified on chest x-ray

  5. Local anesthetic toxicity [ Time Frame: first 48 hours after surgery ]
    Local anesthetic toxicity, as diagnosed clinically

  6. Postoperative Delirium [ Time Frame: first 48 hours after surgery ]
    Delirium as defined by the "Confusion assessment method for the ICU" (CAM-ICU)

  7. Narcotic prescription on discharge [ Time Frame: Upon discharge from hospital after surgery (approximately 1 week after surgery) ]
    Having a narcotic prescription on discharge

  8. Sternal pain at 3 months [ Time Frame: Three months after the day of surgery ]
    Persistent pain at the sternum

  9. Local anesthetic spread [ Time Frame: Immediately as intervention is performed ]
    Number of levels of spread of local anesthetic, as identified by ultrasound


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05191745


Contacts
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Contact: Matthew Cameron, Dr. 1-514-340-8222 ext 25701 matthew.cameron@mcgill.ca

Locations
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Canada, Quebec
Jewish General Hospital Recruiting
Montreal, Quebec, Canada, H3T1E2
Contact: Matthew Cameron, MD    5143408222 ext 25701    matthew.cameron@mcgill.ca   
Sponsors and Collaborators
Jewish General Hospital
More Information
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Responsible Party: Matthew Cameron, Assistant Professor, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT05191745    
Other Study ID Numbers: 2022-3125
First Posted: January 13, 2022    Key Record Dates
Last Update Posted: May 3, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Matthew Cameron, Jewish General Hospital:
Cardiac surgery
Pain