Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial (EPOCH)

Unity Health Toronto

Status: Enrolling

Conditions: Post-operative Delirium; Anesthesia, Local; Post-operative Pain; Opioid Use Disorder; Chronic Pain; Post-cardiac Surgery

Treatments: Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Experimental; Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT06028126

23-038

Details and patient eligibility

About

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.

Full description

This trial is comparing the use of 0.2% ropivacaine and 0.9% saline through a parasternal intercostal plane block and to measure whether there are any tangible changes in:

1. The primary outcome will be cumulative postoperative opioid use (measured as Milligram Morphine Equivalent (MME)) up to 72 hours following catheter insertion.

   Secondary outcomes will be:

2. cumulative postoperative opioid use from catheter insertion up to hospital discharge - measured as MME

3. median pain score - measured at rest and with coughing using a standardized numerical rating scale - for 72 hours post catheter insertion

4. delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.

Enrollment: 340 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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340 participants in 2 patient groups

0.2% ropivacaine

Experimental group

Description:

Intermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of 0.2% ropivacaine per side at the time of catheter placement, followed by intermittent boluses of 10 mL 0.2% ropivacaine per side.

Treatment:

Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Experimental

0.9% saline

Sham Comparator group

Description:

Intermitted superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus of 20 mL of 0.9% saline per side at the time of catheter placement, followed by intermitted boluses of 10 ml of 0.9% saline per side.

Treatment:

Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Sham