Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
NCT ID: NCT06028126
Last Updated: 2025-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
340 participants
INTERVENTIONAL
2023-09-08
2026-01-31
Brief Summary
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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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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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0.2% ropivacaine
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.
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 dosing at the time of catheter placement (20 mL 0.2% ropivacaine), intermittent boluses of 10 mL 0.2% ropivacaine per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.
0.9% saline
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.
Intermittent Superficial Parasternal Intercostal Plane Block - Sham
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 at the time of catheter placement (20 mL 0.9% Saline), intermittent boluses of 10 mL 0.9% Saline per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.
Interventions
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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 dosing at the time of catheter placement (20 mL 0.2% ropivacaine), intermittent boluses of 10 mL 0.2% ropivacaine per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.
Intermittent Superficial Parasternal Intercostal Plane Block - Sham
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 at the time of catheter placement (20 mL 0.9% Saline), intermittent boluses of 10 mL 0.9% Saline per side will be delivered via catheters q6-8 hours for 48 hours post-catheter insertion.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Queen Elizabeth II Health Sciences Centre
OTHER
Foothills Medical Centre
OTHER
Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Ahmad Alli, MD
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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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
Countries
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Central Contacts
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Facility Contacts
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Ahmad Alli
Role: primary
References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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23-038
Identifier Type: -
Identifier Source: org_study_id
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