Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder; Anesthesia, Local; Post-operative Pain; Post-operative Delirium; Post-cardiac Surgery; Chronic Pain
• Interventions: Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Sham; Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Experimental

• Registration Number: NCT06028126
• Lead Sponsor: Unity Health Toronto

Brief 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.

Detailed 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. cumulative postoperative opioid use from catheter insertion until hospital discharge - measured as Milligram Morphine Equivalent (MME)

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

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

Study Timeline

• Study First Submitted: 2023-08-08
• Status Verified: 2023-09
• Study Start: 2023-09
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• Adult patients undergoing cardiac surgery via median sternotomy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
0.9% saline	Intermittent Superficial Parasternal Intercostal Plane Block - Sham	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.
0.2% ropivacaine	Intermittent Superficial Parasternal Intercostal Plane Block - Experimental	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.

Primary Outcome Measures

Name	Time	Method
Cumulative postoperative opioid use up to 72 hours	72 hours	Postoperative opioid use measured using Milligram Morphine Equivalent

Secondary Outcome Measures

Name	Time	Method
Median pain score	over 72 hours post-extubation	Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse)
Cumulative post-operative opioid use	from time of catheter insertion until discharge from hospital	Measured using Milligram Morphine Equivalent
Delirium	for 72 hours following catheter insertion	assessed using Confusion Assessment Method (positive or negative; positive indicates delirium present) or Intensive Care Unit Delirium Screen Checklist Score (minimum 0, maximum 8; higher scores is worse; score greater than 3 is positive for delirium) or more than one dose antipsychotic drug or clinical diagnosis by psychiatrist.
Quality of Recovery-15 Scale	24-96 hours post surgery	Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome)

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada