Loading clinical trials...
Loading clinical trials...
Efficacy of Intermittent Superficial Parasternal Intercostal Plane Block on Postoperative Pain Control in Patients Undergoing Cardiac Surgery With Median Sternotomy - EPOCH Randomized Clinical 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.
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. 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
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Foothills Medical Centre
Calgary, Alberta, Canada
Royal Columbian Hospital
Vancouver, British Columbia, Canada
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Start Date
September 8, 2023
Primary Completion Date
January 6, 2026
Completion Date
March 4, 2026
Last Updated
March 6, 2026
340
ACTUAL participants
Intermittent Superficial Parasternal Intercostal Plane Block - Experimental
PROCEDURE
Intermittent Superficial Parasternal Intercostal Plane Block - Placebo
PROCEDURE
Lead Sponsor
Unity Health Toronto
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06269770