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| Name | Class |
|---|---|
| Queen Elizabeth II Health Sciences Centre | OTHER |
| Foothills Medical Centre | OTHER |
| Royal Columbian Hospital Foundation | OTHER |
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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.2% ropivacaine | 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 after catheter placement, followed by intermittent boluses of 5 mL 0.2% ropivacaine per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side. |
|
| 0.9% saline | Placebo Comparator | Intermittent superficial parasternal intercostal plane block via ultrasound-guided catheter placement. Initial bolus dosing of 20 milliliter (mL) of placebo(0.9% saline) per side after catheter placement, followed by intermittent boluses of 5 mL placebo(0.9% saline) per side every 3-4 hours. There will be a basal infusion rate of 0.1-1mL/hr per side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cumulative postoperative opioid use up to 72 hours | Postoperative opioid use measured using Milligram Morphine Equivalent(MME) from catheter insertion up to 72 hours. | 72 hours after catheter insertion. |
| Measure | Description | Time Frame |
|---|---|---|
| Median pain score | Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse) twice daily | over 72 hours post-extubation |
| Cumulative post-operative opioid use | Measured total opioid use from the time of catheter insertion until discharge from hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Time from catheter insertion to extubation | Measured time from catheter insertion to extubation | Average of 6-8 hours. |
| Time from catheter insertion to first analgesic provision | Measured time from catheter insertion to first analgesic provision following extubation |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmad Alli, MD | Unity Health Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | Canada | |||
| Royal Columbian Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10936130 | Background | Mueller XM, Tinguely F, Tevaearai HT, Revelly JP, Chiolero R, von Segesser LK. Pain location, distribution, and intensity after cardiac surgery. Chest. 2000 Aug;118(2):391-6. doi: 10.1378/chest.118.2.391. | |
| 31054241 | Background | Engelman DT, Ben Ali W, Williams JB, Perrault LP, Reddy VS, Arora RC, Roselli EE, Khoynezhad A, Gerdisch M, Levy JH, Lobdell K, Fletcher N, Kirsch M, Nelson G, Engelman RM, Gregory AJ, Boyle EM. Guidelines for Perioperative Care in Cardiac Surgery: Enhanced Recovery After Surgery Society Recommendations. JAMA Surg. 2019 Aug 1;154(8):755-766. doi: 10.1001/jamasurg.2019.1153. |
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The patient, intervention appliers (i.e. the operating room staff), medical practitioners, and outcome assessors will all be blinded to the randomized treatment arm until the database is locked. Unblinding procedures will be made available for breaking codes if necessary for clinical treatment.
|
| 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. |
|
| Average of 5 days. |
| Delirium | 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. | for 72 hours following catheter insertion |
| Quality of Recovery-15 Scale | Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome) | 24-96 hours post surgery |
| Average of 8 hours. |
| Time from catheter insertion to mobilization | Measured time from catheter insertion to mobilization | Average of 10 hours. |
| ICU and hospital length of stay | From the date of index surgery to the date of ICU discharge and Hospital discharge. | Average of 36 hours for ICU stay and 5 days for hospital stay. |
| Postoperative nausea and vomiting | 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. | Up to 72 hours following catheter insertion |
| Participant reported outcome measures: PROMIS-29 Scoring | 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. | Assessed at baseline preoperatively, 6 weeks +/-2 weeks, and 3 months +/- 4 weeks |
| Chronic Post-sternotomy Pain | Assessed using McGill Pain Questionnaire (minimum 0, maximum 78; higher scores mean a worse outcome) | Assessed at 3 months +/- 4 weeks |
| Vancouver |
| British Columbia |
| Canada |
| QEII Health Sciences Centre | Halifax | Nova Scotia | NS B3H 3A7 | Canada |
| St. Michael's Hospital | Toronto | Ontario | M5B 1W8 | Canada |
| 34601602 | Background | Zhang Y, Min J, Chen S. Continuous Pecto-Intercostal Fascial Block Provides Effective Analgesia in Patients Undergoing Open Cardiac Surgery: A Randomized Controlled Trial. Pain Med. 2022 Mar 2;23(3):440-447. doi: 10.1093/pm/pnab291. |
| 36581838 | Background | Dost B, De Cassai A, Balzani E, Tulgar S, Ahiskalioglu A. Effects of ultrasound-guided regional anesthesia in cardiac surgery: a systematic review and network meta-analysis. BMC Anesthesiol. 2022 Dec 29;22(1):409. doi: 10.1186/s12871-022-01952-7. |
| 32859487 | Background | Kumar AK, Chauhan S, Bhoi D, Kaushal B. Pectointercostal Fascial Block (PIFB) as a Novel Technique for Postoperative Pain Management in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2021 Jan;35(1):116-122. doi: 10.1053/j.jvca.2020.07.074. Epub 2020 Jul 30. |
| 32584934 | Background | Brown CR, Chen Z, Khurshan F, Groeneveld PW, Desai ND. Development of Persistent Opioid Use After Cardiac Surgery. JAMA Cardiol. 2020 Aug 1;5(8):889-896. doi: 10.1001/jamacardio.2020.1445. |
| 22956490 | Background | Barletta JF. Clinical and economic burden of opioid use for postsurgical pain: focus on ventilatory impairment and ileus. Pharmacotherapy. 2012 Sep;32(9 Suppl):12S-8S. doi: 10.1002/j.1875-9114.2012.01178.x. |
| 6150663 | Background | Bovill JG, Sebel PS, Stanley TH. Opioid analgesics in anesthesia: with special reference to their use in cardiovascular anesthesia. Anesthesiology. 1984 Dec;61(6):731-55. |
| 29026331 | Background | Gan TJ. Poorly controlled postoperative pain: prevalence, consequences, and prevention. J Pain Res. 2017 Sep 25;10:2287-2298. doi: 10.2147/JPR.S144066. eCollection 2017. |
| 42256617 | Derived | Alli A, Mazer CD, Dennis F, Teoh H, Chin K, Quan A, Hassan SMA, Szarek M, Tran JD, Dhingra NK, Ghiringhelli JP, de Vasconcelos Papa F, Lee Y, Ricci MJ, Verma R, Derry KL, George T, Krishnaraj A, Hess DA, Rotstein OD, Cook RC, Hassan A, Yau TM, Spence JD, Martinka PM, Sutherland K, Gregory AJ, Noss CD, de Jager P, Dougherty JL, Arora RC, Verma S. Superficial parasternal intercostal plane block with ropivacaine versus placebo for opioid exposure after cardiac surgery (EPOCH CardioLink-10): a multicentre, double-blind, randomised trial. Lancet Reg Health Am. 2026 May 28;60:101508. doi: 10.1016/j.lana.2026.101508. eCollection 2026 Aug. |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D000071257 | Emergence Delirium |
| D059350 | Chronic Pain |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
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