NCT06028126

Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 340 (actual)
• Sponsor: Unity Health Toronto · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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

Conditions

• Post-operative Pain
• Post-operative Delirium
• Post-cardiac Surgery
• Chronic Pain
• Opioid Use Disorder
• Anesthesia, Local

Interventions

Type	Name	Description
PROCEDURE	Intermittent Superficial Parasternal Intercostal Plane Block - Experimental	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.
PROCEDURE	Intermittent Superficial Parasternal Intercostal Plane Block - Placebo	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.

Timeline

• Start date: 2023-09-08
• Primary completion: 2026-01-06
• Completion: 2026-03-04
• First posted: 2023-09-08
• Last updated: 2026-03-06

Locations

4 sites across 1 country: Canada