Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

NCT06028126 | Completed

• 1 other identifier: 23-038
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (4)

• Median pain score

  over 72 hours post-extubation

• Cumulative post-operative opioid use

  Average of 5 days.

• Delirium

  for 72 hours following catheter insertion

• Quality of Recovery-15 Scale

  24-96 hours post surgery

Other Outcomes (7)

• Time from catheter insertion to extubation

  Average of 6-8 hours.

• Time from catheter insertion to first analgesic provision

  Average of 8 hours.

• Time from catheter insertion to mobilization

  Average of 10 hours.

Study Arms (2)

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.

Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Experimental

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.

Procedure: Intermittent Superficial Parasternal Intercostal Plane Block - Placebo

Interventions

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.

0.2% ropivacaine

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.

0.9% saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients undergoing cardiac surgery via median sternotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Unity Health Toronto: lead
• Queen Elizabeth II Health Sciences Centre: collaborator
• Foothills Medical Centre: collaborator
• Royal Columbian Hospital Foundation: collaborator

Study Sites (4)

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Royal Columbian Hospital

Vancouver, British Columbia, Canada

Location

QEII Health Sciences Centre

Halifax, Nova Scotia, NS B3H 3A7, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Related Publications (9)

• 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.

  PMID: 10936130 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.

  PMID: 31054241 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.

  PMID: 34601602 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.

  PMID: 36581838 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.

  PMID: 32859487 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.

  PMID: 32584934 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.

  PMID: 22956490 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.

  PMID: 6150663 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.

  PMID: 29026331 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Emergence Delirium; Chronic Pain; Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Delirium; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Ahmad Alli, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2023
• First Posted: September 8, 2023
• Study Start: September 8, 2023
• Primary Completion: January 6, 2026
• Study Completion: March 4, 2026
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)