EPOCH: Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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:
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cumulative postoperative opioid use from catheter insertion until hospital discharge - measured as Milligram Morphine Equivalent (MME)
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median pain score - measured at rest and with coughing using a standardized numerical rating scale - over 72 hours post catheter insertion
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delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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. |
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.
|
| Sham Comparator: 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. |
Procedure: 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.
|
Outcome Measures
Primary Outcome Measures
- Cumulative postoperative opioid use up to 72 hours [72 hours]
Postoperative opioid use measured using Milligram Morphine Equivalent
Secondary Outcome Measures
- Median pain score [over 72 hours post-extubation]
Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse)
- Cumulative post-operative opioid use [from time of catheter insertion until discharge from hospital]
Measured using Milligram Morphine Equivalent
- Delirium [for 72 hours following catheter insertion]
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.
- Quality of Recovery-15 Scale [24-96 hours post surgery]
Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome)
Other Outcome Measures
- Time from catheter insertion to extubation [from time of catheter insertion until extubation]
Measured time from catheter insertion to extubation
- Time from catheter insertion to first analgesic request [immediately after the intervention]
Measured time from catheter insertion to first analgesic request
- Time from catheter insertion to mobilization [From the time of catheter insertion to mobilization]
Measured time from catheter insertion to mobilization
- ICU and hospital length of stay [From date of surgery until date of ICU and Hospital discharge]
Measured time of ICU and hospital length of stay
- Postoperative nausea and vomiting [Up to 72 hours following catheter insertion]
Measured via a 10-point visual analogue scale (minimum 0, maximum 10; higher scores are worse)
- Quality of Recovery-15 Scale [Post-operative day 4-7]
Assessed using Quality of Recovery-15 Scale (minimum: 0, maximum: 150; higher scores mean a better outcome)
- Post thoracotomy Pain [Assessed at 3 months +/- 4 weeks]
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.)
Eligibility Criteria
Criteria
Inclusion Criteria:
- Adult patients undergoing cardiac surgery via median sternotomy
Exclusion Criteria:
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Redo sternotomy, or cardiac surgery performed through non-sternotomy approaches (minimally invasive procedures, thoracotomies, mini-sternotomy, hemi-sternotomy, etc.)
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Emergency procedures (surgery within 2 hours)
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Clinical instability which in the judgement of the investigator precludes enrollment or participation in the study
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Weight < 50kg
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Active systemic bacterial infection including infective endocarditis or pre-existing sternal infections
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Surgery for infective endocarditis
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Pregnancy or nursing
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Chronic opioid/narcotic use > 6 weeks, active use of illicit drugs, long-term opioid exposure or chronic pain disorder/syndromes
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Allergies to amide anesthetic agents or any components of study interventions
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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.)
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Receipt of an investigational drug or device within past 7 days
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Michael's Hospital | Toronto | Ontario | Canada | M5B 1W8 |
Sponsors and Collaborators
- Unity Health Toronto
Investigators
- Principal Investigator: Ahmad Alli, MD, Unity Health Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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