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Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial (EPOCH)

Primary Purpose

Post-operative Pain, Post-operative Delirium, Post-cardiac Surgery

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Intermittent Superficial Parasternal Intercostal Plane Block - Experimental

Intermittent Superficial Parasternal Intercostal Plane Block - Sham

About this trial

This is an interventional treatment trial for Post-operative Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

St. Michael's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

0.2% ropivacaine

0.9% saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Cumulative postoperative opioid use up to 72 hours

Postoperative opioid use measured using Milligram Morphine Equivalent

Secondary Outcome Measures

Median pain score

Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse)

Cumulative post-operative opioid use

Measured using Milligram Morphine Equivalent

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.

Quality of Recovery-15 Scale

Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome)

Full Information

NCT ID

NCT06028126

First Posted

August 8, 2023

Last Updated

September 13, 2023

Sponsor

Unity Health Toronto

1. Study Identification

Unique Protocol Identification Number

NCT06028126

Brief Title

Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 2023 (Anticipated)

Primary Completion Date

August 2025 (Anticipated)

Study Completion Date

August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Unity Health Toronto

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

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: cumulative postoperative opioid use from catheter insertion until hospital discharge - measured as Milligram Morphine Equivalent (MME) median pain score - measured at rest and with coughing using a standardized numerical rating scale - over 72 hours post catheter insertion delirium - assessed twice daily using institutional scores up to 72 hours following catheter insertion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

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.

Allocation

Randomized

Enrollment

310 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

0.2% ropivacaine

Arm Type

Experimental

Arm Description

Arm Title

0.9% saline

Arm Type

Sham Comparator

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Intermittent Superficial Parasternal Intercostal Plane Block - Experimental

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Intermittent Superficial Parasternal Intercostal Plane Block - Sham

Intervention Description

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.

Primary Outcome Measure Information:

Title

Cumulative postoperative opioid use up to 72 hours

Description

Postoperative opioid use measured using Milligram Morphine Equivalent

Time Frame

72 hours

Secondary Outcome Measure Information:

Title

Median pain score

Description

Measured using visual analog pain scale (minimum 0, maximum 10; higher is worse)

Time Frame

over 72 hours post-extubation

Title

Cumulative post-operative opioid use

Description

Measured using Milligram Morphine Equivalent

Time Frame

from time of catheter insertion until discharge from hospital

Title

Delirium

Description

Time Frame

for 72 hours following catheter insertion

Title

Quality of Recovery-15 Scale

Description

Assessed using Quality of Recovery-15 Scale (minimum 0, maximum 150; higher scores mean a better outcome)

Time Frame

24-96 hours post surgery

Other Pre-specified Outcome Measures:

Title

Time from catheter insertion to extubation

Description

Measured time from catheter insertion to extubation

Time Frame

from time of catheter insertion until extubation

Title

Time from catheter insertion to first analgesic request

Description

Measured time from catheter insertion to first analgesic request

Time Frame

immediately after the intervention

Title

Time from catheter insertion to mobilization

Description

Measured time from catheter insertion to mobilization

Time Frame

From the time of catheter insertion to mobilization

Title

ICU and hospital length of stay

Description

Measured time of ICU and hospital length of stay

Time Frame

From date of surgery until date of ICU and Hospital discharge

Title

Postoperative nausea and vomiting

Description

Measured via a 10-point visual analogue scale (minimum 0, maximum 10; higher scores are worse)

Time Frame

Up to 72 hours following catheter insertion

Title

Quality of Recovery-15 Scale

Description

Assessed using Quality of Recovery-15 Scale (minimum: 0, maximum: 150; higher scores mean a better outcome)

Time Frame

Post-operative day 4-7

Title

Post thoracotomy Pain

Description

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.)

Time Frame

Assessed at 3 months +/- 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Adrian Quan, M.Phil.

Phone

416-864-6060

Ext

77626

adrian.quan@unityhealth.to

First Name & Middle Initial & Last Name or Official Title & Degree

Ahmad Alli, MD

Phone

4373441546

ahmad.alli@unityhealth.to

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ahmad Alli, MD

Organizational Affiliation

Unity Health Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B 1W8

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ahmad Alli

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

10936130

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.

Results Reference

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PubMed Identifier

31054241

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.

Results Reference

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PubMed Identifier

34601602

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.

Results Reference

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PubMed Identifier

36581838

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.

Results Reference

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PubMed Identifier

32859487

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.

Results Reference

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PubMed Identifier

32584934

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.

Results Reference

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PubMed Identifier

22956490

Citation

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.

Results Reference

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PubMed Identifier

6150663

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.

Results Reference

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PubMed Identifier

29026331

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.

Results Reference

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Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial

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