Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

Chronic Pain Clinical Trial

— EPOCH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06028126
• Other study ID #: 23-038
• Status: Recruiting
• Phase: N/A
• Start date: September 2023
• Est. completion date: August 2025

Study information

• Verified date: September 2023
• Source: Unity Health Toronto
• Contact: Adrian Quan, M.Phil.
• Phone: 416-864-6060
• Email: adrian.quan[@]unityhealth.to
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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. cumulative postoperative opioid use from catheter insertion until hospital discharge - measured as Milligram Morphine Equivalent (MME)

2. median pain score - measured at rest and with coughing using a standardized numerical rating scale - over 72 hours post catheter insertion

3. delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult patients undergoing cardiac surgery via median sternotomy

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Anesthesia, Local
• Chronic Pain
• Emergence Delirium
• Opioid Use Disorder
• Opioid-Related Disorders
• Pain, Postoperative
• Post-cardiac Surgery
• Post-operative Delirium
• Post-operative Pain

Intervention

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 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.

Locations

Country	Name	City	State
Canada	St. Michael's Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Unity Health Toronto

Country where clinical trial is conducted

Canada, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time from catheter insertion to extubation	Measured time from catheter insertion to extubation	from time of catheter insertion until extubation
Other	Time from catheter insertion to first analgesic request	Measured time from catheter insertion to first analgesic request	immediately after the intervention
Other	Time from catheter insertion to mobilization	Measured time from catheter insertion to mobilization	From the time of catheter insertion to mobilization
Other	ICU and hospital length of stay	Measured time of ICU and hospital length of stay	From date of surgery until date of ICU and Hospital discharge
Other	Postoperative nausea and vomiting	Measured via a 10-point visual analogue scale (minimum 0, maximum 10; higher scores are worse)	Up to 72 hours following catheter insertion
Other	Quality of Recovery-15 Scale	Assessed using Quality of Recovery-15 Scale (minimum: 0, maximum: 150; higher scores mean a better outcome)	Post-operative day 4-7
Other	Post thoracotomy Pain	Assessed using McGill Pain Questionnaire (minimum 0, maximum 78; higher scores mean a worse outcome) and Patient-Reported Outcomes Measurement Information System 29-Item Profile (PROMIS 29) 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 3 months +/- 4 weeks
Primary	Cumulative postoperative opioid use up to 72 hours	Postoperative opioid use measured using Milligram Morphine Equivalent	72 hours
Secondary	Median pain score	Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse)	over 72 hours post-extubation
Secondary	Cumulative post-operative opioid use	Measured using Milligram Morphine Equivalent	from time of catheter insertion until discharge from hospital
Secondary	Delirium	assessed 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
Secondary	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