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Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

RECRUITINGN/ASponsored by Unity Health Toronto
Actively Recruiting
PhaseN/A
SponsorUnity Health Toronto
Started2023-09-08
Est. completion2026-01
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

The goal of this clinical trial is to assess whether the use of intermittent superficial parasternal intercostal plane blocks reduces opioid usage in patients undergoing cardiac surgery with median sternotomy. Participants randomized to the intervention group will receive the blocks with 0.2% ropivacaine administered via catheters placed in the superficial parasternal intercostal plane bilaterally under ultrasound guidance. Researchers will compare this group with a control group given 0.9% saline through similarly placed catheters. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Adult patients undergoing cardiac surgery via median sternotomy

Exclusion Criteria:

* Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.)
* Emergency procedures (surgery within 2 hours)
* Clinical instability which in the judgement of the investigator precludes enrollment or participation in the study
* Weight \< 50kg
* Active systemic bacterial infection including infective endocarditis or pre-existing sternal infections
* Surgery for infective endocarditis
* Pregnancy or nursing
* Chronic opioid/narcotic use \> 6 weeks, active use of illicit drugs, long-term opioid exposure or chronic pain disorder/syndromes
* Allergies to amide anesthetic agents or any components of study interventions
* Inability to comply with, or participate in, protocol (i.e. cognitive impairment/altered mental status/neurological deficit or disorder, inability to provide informed consent, inability to complete pain rating scales, etc.)
* Receipt of an investigational drug or device within past 7 days

Conditions7

Anesthesia, LocalChronic PainHeart DiseaseOpioid Use DisorderPost Operative PainPost-cardiac SurgeryPost-operative Delirium

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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