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Completed

NCT Number: NCT05191745

Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery

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.

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Key information

Conditions

Coronary Artery Bypass Graft Surgery Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Jewish General Hospital

Montreal, Quebec, H3T1E2, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Parasternal blocks

Drug

Parasternal block with Bupivacaine 0.25% + Epinephrine 1:200,000 x 60cc + Dexamethasone 5mg and Dexmedetomidine 50mcg

Other names: pecto-intercostal fascial blocks

Standard of care

Drug

All standard management of postoperative pain, as per local protocols

Primary outcomes

  1. Pain with inspirometry at 24 hours after surgery

    Time frame: 24 hours after surgery

    Numerical Rating Scale (NRS) 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 outcomes

  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

    Numerical Rating Scale (NRS) 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

    Numerical Rating Scale (NRS) 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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jewish General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jan 13, 2022
Registry last updated
Jun 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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