Clinical trial NCT05191745: Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery
Official title: Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery: A Randomized, Controlled, Double-Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Coronary Artery Bypass Graft Surgery
Keywords: Cardiac surgery
Pain
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2022-01-13
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Eligibility 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.

Primary outcomes:
measure: Pain with inspirometry at 24 hours after surgery
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Opioid consumption
timeFrame: 12, 24 and 48 hours after surgery
measure: Amount of rescue analgesia administered
timeFrame: Total in the first 48 hours after surgery
measure: Pain score at rest
timeFrame: 12, 24 and 48 hours after surgery
measure: Pain score with inspirometry
timeFrame: 12 and 48 hours after surgery
measure: Intensive Care Unit (ICU) Length of Stay
timeFrame: From surgery until discharge from the ICU, assessed from the date of surgery up until 6 months after the completion of the study
measure: Hospital Length of Stay
timeFrame: 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
measure: Inspirometry
timeFrame: 24 hours after surgery
measure: Patient satisfaction with pain control
timeFrame: at 48 hours after surgery
measure: Mobilization
timeFrame: From ICU arrival until first mobilization (approximately first 48 hours postoperatively)
measure: Ambulation
timeFrame: From ICU arrival until first ambulation (approximately first 72 hours postoperatively)
Other outcomes:
measure: Presence of postoperative vomiting
timeFrame: first 48 hours after surgery
measure: Incidence of bradycardia
timeFrame: first 48 hours after surgery
measure: Incidence of hyperglycemia
timeFrame: first 48 hours after surgery
measure: Incidence of a pneumothorax
timeFrame: first 48 hours after surgery
measure: Local anesthetic toxicity
timeFrame: first 48 hours after surgery
measure: Postoperative Delirium
timeFrame: first 48 hours after surgery
measure: Narcotic prescription on discharge
timeFrame: Upon discharge from hospital after surgery (approximately 1 week after surgery)
measure: Sternal pain at 3 months
timeFrame: Three months after the day of surgery
measure: Local anesthetic spread
timeFrame: Immediately as intervention is performed
Locations:
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
References: