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Completed

NCT Number: NCT06028126

Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

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.

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Key information

Conditions

Post-operative Pain Anesthesia, Local Chemically-Induced Disorders Chronic Pain Confusion Delirium Emergence Delirium Mental Disorders Narcotic-Related Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Opioid Use Disorder Opioid-Related Disorders Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Post-cardiac Surgery Post-operative Delirium Postoperative Complications Signs and Symptoms Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

Loading trial locations.

About this study

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:

  • 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:

  • cumulative postoperative opioid use from catheter insertion up to hospital discharge - measured as MME
  • median pain score - measured at rest and with coughing using a standardized numerical rating scale - for 72 hours post catheter insertion
  • delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.

5.) Quality of Recovery -15 (QoR-15) score 24-96 hours post-surgery

Tertiary outcomes will be:

6.) time from catheter insertion to extubation 7.) time from catheter insertion to first opioid analgesic provision following extubation 8.) time from catheter insertion to mobilization 9.) lengths of stay in the intensive care unit and the hospital 10.) postoperative nausea and vomiting - measured twice a day and antiemetic medication requirements for the 72 hours after catheter insertion 11.) opioid requirements following discharge from the hospital 12.) chronic post-sternotomy pain/disability (McGill Pain Questionnaire) 13.) participant-reported outcomes (PROMIS-29 survey) at 6 weeks and 3 months post surgery

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Intermittent Superficial Parasternal Intercostal Plane Block - Experimental

Procedure

Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin.

Following initial bolus after catheter placement (20 mL 0.2% ropivacaine), intermittent boluses of 5 mL 0.2% ropivacaine will be delivered via catheters for 48 hours post-catheter insertion per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side.

Intermittent Superficial Parasternal Intercostal Plane Block - Placebo

Procedure

Catheter insertion will be performed by an anesthesiologist with regional block training immediately following skin closure in the operating room. Catheters will be inserted under ultrasound guidance, in a sterile fashion, with a high-frequency linear transducer which will be placed 1 cm lateral to the sternal border in the longitudinal plane in order to view the T4-T5 intercostal space. A Tuohy needle will be used to enter the superficial parasternal intercostal plane, with saline being injected to help visualize the plane between the pectoralis major and intercostal muscles. Subsequently, the catheters will be advanced into the plane, and secured on the skin.

Following initial bolus dosing after catheter placement (20 mL placebo(0.9% saline)), intermittent boluses of 5 mL Placebo(0.9% saline) will be delivered via catheters for 48 hours post-catheter insertion per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side.

Primary outcomes

  1. Cumulative postoperative opioid use up to 72 hours

    Time frame: 72 hours after catheter insertion.

    Postoperative opioid use measured using Milligram Morphine Equivalent(MME) from catheter insertion up to 72 hours.

Secondary outcomes

  1. Median pain score

    Time frame: over 72 hours post-extubation

    Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse) twice daily

  2. Cumulative post-operative opioid use

    Time frame: Average of 5 days.

    Measured total opioid use from the time of catheter insertion until discharge from hospital

  3. Delirium

    Time frame: for 72 hours following catheter insertion

    assessed twice daily 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.

  4. Quality of Recovery-15 Scale

    Time frame: 24-96 hours post surgery

    Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome)

Other outcomes

  1. Time from catheter insertion to extubation

    Time frame: Average of 6-8 hours.

    Measured time from catheter insertion to extubation

  2. Time from catheter insertion to first analgesic provision

    Time frame: Average of 8 hours.

    Measured time from catheter insertion to first analgesic provision following extubation

  3. Time from catheter insertion to mobilization

    Time frame: Average of 10 hours.

    Measured time from catheter insertion to mobilization

  4. ICU and hospital length of stay

    Time frame: Average of 36 hours for ICU stay and 5 days for hospital stay.

    From the date of index surgery to the date of ICU discharge and Hospital discharge.

  5. Postoperative nausea and vomiting

    Time frame: Up to 72 hours following catheter insertion

    Measured twice a day via a 10-point visual analogue scale (minimum 0, maximum 10; higher scores are worse), and additionally assessed by the total amount of antiemetics given in the specified time frame.

  6. Participant reported outcome measures: PROMIS-29 Scoring

    Time frame: Assessed at baseline preoperatively, 6 weeks +/-2 weeks, and 3 months +/- 4 weeks

    PROMIS-29 tool with Subsections:

    Physical Function: 4-20, higher scores is better outcome. Anxiety: 4-20, higher scores is worse outcome. Depression: 4-20, higher scores is worse outcome. Fatigue: 4-20, higher scores is worse outcome. Sleep Disturbance: 4-20, higher scores is worse outcome. Ability to Participate in Social Roles and Activities: 4-20, higher scores is better outcome.

    Pain Interference: 4-20, higher scores is worse outcome. Pain Intensity: 0-10 higher scores is worse outcome.

  7. Chronic Post-sternotomy Pain

    Time frame: Assessed at 3 months +/- 4 weeks

    Assessed using McGill Pain Questionnaire (minimum 0, maximum 78; higher scores mean a worse outcome)

Sponsors and collaborators

Lead sponsor

Unity Health Toronto

Other

Collaborators

  • Foothills Medical Centre
  • Queen Elizabeth II Health Sciences Centre
  • Royal Columbian Hospital Foundation

Registry information

Official study title

Efficacy of Intermittent Superficial Parasternal Intercostal Plane Block on Postoperative Pain Control in Patients Undergoing Cardiac Surgery With Median Sternotomy - EPOCH Randomized Clinical Trial

Acronym: EPOCH

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2023
Registry last updated
Mar 6, 2026

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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