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Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology (SPIFFY)

Primary Purpose

Post-operative Pain

Status
Recruiting
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Pectointercostal fascia blocks
Placebo
Sponsored by
University of Alberta
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-operative Pain focused on measuring sternotomy, regional anesthesia, pectointercoastal fascia block, fast-track cardiac surgery, post-operative pain, truncal nerve block, cardiac surgery, cardiac anesthesia

Eligibility Criteria

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

Inclusion Criteria:

  • adult patients presenting to the Mazankowski Heart Institute for operations via full midline sternotomy, i.e.: coronary artery bypass grafting, and/or single valve repair or single valve replacement who are expected to be fast track candidates post-operatively.
  • patients scheduled for cardiac bypass grafting and/or single valve surgery requiring cardiopulmonary bypass.

Exclusion Criteria:

  • Unstable or fluctuating cardiac condition (acute MI, HF, tamponade, type A dissection, ongoing refractory arrhythmia, LVEF <40%, massive transfusion protocol, reinstitution of CPB or other mechanical support)
  • Alternative surgical approach (e.g. thoracotomy, mini sternotomy)
  • Repeat sternotomy or emergency surgery
  • Pregnancy or lactation
  • Age <18
  • Chronic pain
  • Tolerance to opioids
  • Active alcohol misuse disorder, IVDU or cannabis use >1g/d
  • Allergy to local anesthetics
  • Inability to provide informed consent
  • High doses of steroids pre-operatively (>10 mg prednisone/day)

Sites / Locations

  • Gerhardus Heart van RensburgRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Placebo

Arm Description

This group of patients will undergo placement of US guided pectointercostal fascia blocks.

The control group patients will receive the same intraoperative analgesia management. A PIF block will not be performed, instead, a peripheral nerve block catheter will be secured to the skin surface and connected to a CADD™ pump. As the catheter is taped to the skin surface the control group patients will not be exposed to the risks of peripheral nerve block placement.

Outcomes

Primary Outcome Measures

Opioid consumption
Cumulative opioid consumption in milligrams of morphine in the first 12 hours after surgery.

Secondary Outcome Measures

Opioid consumption in 24 hours
Amount of opioid consumed in 24 hours
Time to extubation
Time until ETT is removed post-operatively.
Pain score
Pain score as reported using the numeric rating scale
ICU length of stay
Length of stay in ICU
Surgical site infection rate
Until hospital discharge
Local anesthetic systemic toxicity effects
As evidenced by: tinnitus, perioral numbness, metallic taste

Full Information

First Posted
November 22, 2021
Last Updated
January 5, 2023
Sponsor
University of Alberta
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1. Study Identification

Unique Protocol Identification Number
NCT05146453
Brief Title
Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology
Acronym
SPIFFY
Official Title
Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 22, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This study is looking to see if a regional block placed on each side of the incision after surgery helps with pain relief. Ultrasound-guided pectointercostal fascia blocks will be placed at the conclusion of surgery following application of dressings. Patients will be in the supine position with the surgical drapes in place. The blocks are performed using a high frequency linear transducer with aseptic technique. The investigators hypothesize that placement of PIF blocks and catheters will decrease acute postoperative pain from midline sternotomy in fast track cardiac surgery patients compared to the current standard of care. A physician will place an ultrasound guided pecto-intercostal fascial plane blocks bilaterally at the conclusion of surgery. They will also leave a catheter, similar to a small IV, between the muscle layers where the freezing medication goes. This will let the investigators give more freezing medication over the first 24 hours after surgery. The freezing medication blocks the pain signals from travelling to your brain from your incision, which might help participants need fewer narcotics after surgery. Some of the research on this block shows a trend toward reduced pain, but the use of a catheter to allow repeat doses of freezing medication has not been studied. The investigators hope to show that this regional block means participants need less opioids (narcotics) in the first 2 days after their heart surgery. In order to see whether the regional block is helpful there will be two groups of study participants. Both groups will receive infusion catheters covered with opaque bandages however one group will receive the study drug (ropivacaine) and the other will not (placebo). To reduce the risks to placebo group participants, those participants will have a catheter taped to their skin surface under an opaque dressing. This will give the illusion of block placement without the risks of a needle poking through skin. Both groups will still be given pain medications by IV or by mouth as needed after the surgery.
Detailed Description
Acute postoperative pain at median sternotomy sites is common in cardiac surgery patients. Inadequate control of acute pain can lead to sympathetic activation, hemodynamic sequelae, respiratory compromise, delirium and contributes to the development of chronic pain. Parental opioids have long been at the forefront of perioperative pain management for cardiac surgery patients, historically in large intravenous doses. With the onset of fast-track cardiac anesthesia (FTCA) which emphasizes reduced periods of post-operative mechanical ventilation, intensive care unit stay and overall health care cost; new strategies for managing post-operative pain in cardiac surgery patients are required. Opioid focused strategies contribute to many side effects including sedation, confusion, apnea, nausea, emesis, and ileusF , which can prevent effective fast tracking of these patients. FTCA has highlighted the potential for regional anesthetic techniques to revolutionize post-operative cardiac surgery care. Though thoracic epidural analgesia offers excellent analgesia for post-sternotomy pain, the small but catastrophic risk of epidural hematoma in heparinized patients has hindered it from becoming standard of care. Over the last decade, various thoracic wall blocks have been developed and shown to benefit patients presenting for thoracic or breast surgeries, and sternotomies. Of these, fascial plane thoracic wall blocks offer the advantages of being simple to perform ultrasound equipment and having low complications rates. One such block is the pectointercostal fascia (PIF) block which was first described in 2014 as an analgesic adjunct for breast procedures. In this block the fascial plane between the pectoralis major and internal intercostal muscles is infiltrated with local anesthetic with the aim of anesthetizing the anterior cutaneous branches of the intercostal nerves, thereby providing analgesia to the anterior chest wall from T2 to T6 with a single injection. The block can be placed with ultrasound guidance with the patient in the supine position - making it easy to place in the operating room or as a rescue block in CVICU. Despite the higher volumes of local anesthetic required for a plane block of this nature, previous studies have shown that the serum levels of local anesthetic remain well below the toxic rangeI,J. Injection into the fascial plane allows for excellent spread of local anesthetic along multiple rib spaces, precluding the need for multiple injections. It also opens up a space for placement of a catheter thus providing the option of longer term analgesia in postoperative patients. While PIF blocks avoid the hemodynamic side effects and risk of neuraxial complications associated with thoracic epidurals and paravertebral catheters they are not without risk. These risks include potential hemothorax, pneumothorax, chest wall hematoma, local anesthetic systemic toxicity and surgical site infection.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain
Keywords
sternotomy, regional anesthesia, pectointercoastal fascia block, fast-track cardiac surgery, post-operative pain, truncal nerve block, cardiac surgery, cardiac anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
the physicians placing the nerve blocks will not be blinded to the treatment group. The post-operative care team including the nurses doing pain assessments and management will be blinded to group allocation.
Allocation
Randomized
Enrollment
156 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
This group of patients will undergo placement of US guided pectointercostal fascia blocks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The control group patients will receive the same intraoperative analgesia management. A PIF block will not be performed, instead, a peripheral nerve block catheter will be secured to the skin surface and connected to a CADD™ pump. As the catheter is taped to the skin surface the control group patients will not be exposed to the risks of peripheral nerve block placement.
Intervention Type
Procedure
Intervention Name(s)
Pectointercostal fascia blocks
Other Intervention Name(s)
peripheral nerve block, regional anesthesia
Intervention Description
PIF blocks will be placed at the conclusion of surgery with the surgical drapes in place. The blocks are performed using a high frequency linear transducer with aseptic technique. The ultrasound probe is placed longitudinally 3 cm from the sternum at the level of the 4th-6th intercostal space. Using an in-plane approach, an echogenic needle will be advanced into the fascial plane between pectoralis major and the external intercostal muscles. Peripheral nerve block catheters will then be inserted and secured to the skin surface with tegaderm. For patients weighing over 70 kg, 20 mL of 0.5% ropivacaine will be administered. This will be reduced to 15mL per side for patients weighing less than 70 kg. A CADD™ pump will be connected to each catheter and programmed to deliver 20 mL boluses of ropivacaine 0.2% starting at postoperative hour 2. The boluses will be staggered every 2 hours on alternate sides until hour 24. The catheters will be removed 24 hours post-operatively.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
The control group patients will receive the same intraoperative analgesia management. A PIF block will not be performed, instead, a peripheral nerve block catheter will be secured to the skin surface and connected to a CADD™ pump. As the catheter is taped to the skin surface the control group patients will not be exposed to the risks of peripheral nerve block placement.
Primary Outcome Measure Information:
Title
Opioid consumption
Description
Cumulative opioid consumption in milligrams of morphine in the first 12 hours after surgery.
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Opioid consumption in 24 hours
Description
Amount of opioid consumed in 24 hours
Time Frame
24 hours post-operatively
Title
Time to extubation
Description
Time until ETT is removed post-operatively.
Time Frame
24 hours
Title
Pain score
Description
Pain score as reported using the numeric rating scale
Time Frame
Every 6 hours for 24 hours post-operatively
Title
ICU length of stay
Description
Length of stay in ICU
Time Frame
2 weeks
Title
Surgical site infection rate
Description
Until hospital discharge
Time Frame
4 weeks
Title
Local anesthetic systemic toxicity effects
Description
As evidenced by: tinnitus, perioral numbness, metallic taste
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients presenting to the Mazankowski Heart Institute for operations via full midline sternotomy, i.e.: coronary artery bypass grafting, and/or single valve repair or single valve replacement who are expected to be fast track candidates post-operatively. patients scheduled for cardiac bypass grafting and/or single valve surgery requiring cardiopulmonary bypass. Exclusion Criteria: Unstable or fluctuating cardiac condition (acute MI, HF, tamponade, type A dissection, ongoing refractory arrhythmia, LVEF <40%, massive transfusion protocol, reinstitution of CPB or other mechanical support) Alternative surgical approach (e.g. thoracotomy, mini sternotomy) Repeat sternotomy or emergency surgery Pregnancy or lactation Age <18 Chronic pain Tolerance to opioids Active alcohol misuse disorder, IVDU or cannabis use >1g/d Allergy to local anesthetics Inability to provide informed consent High doses of steroids pre-operatively (>10 mg prednisone/day)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gerhardus van Rensburg
Phone
780-407-8861
Email
gerryvanrensburg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wing Lam
Organizational Affiliation
University of Alberta
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gerhardus Heart van Rensburg
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2G3
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerhardus H van Rensburg
Phone
17804078861
Email
gerryvanrensburg@gmail.com
First Name & Middle Initial & Last Name & Degree
Megan McLachlan, MD
First Name & Middle Initial & Last Name & Degree
Emma Torbicki, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32032103
Citation
Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.
Results Reference
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PubMed Identifier
31360703
Citation
Fujii S, Bairagi R, Roche M, Zhou JR. Transversus Thoracis Muscle Plane Block. Biomed Res Int. 2019 Jul 7;2019:1716365. doi: 10.1155/2019/1716365. eCollection 2019.
Results Reference
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PubMed Identifier
34022969
Citation
Lloyd-Donald P, Lee WS, Hooper JW, Lee DK, Moore A, Chandra N, McCall P, Seevanayagam S, Matalanis G, Warrillow S, Weinberg L. Fast-track recovery program after cardiac surgery in a teaching hospital: a quality improvement initiative. BMC Res Notes. 2021 May 22;14(1):201. doi: 10.1186/s13104-021-05620-w.
Results Reference
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PubMed Identifier
32275036
Citation
Kar P, Ramachandran G. Pain relief following sternotomy in conventional cardiac surgery: A review of non neuraxial regional nerve blocks. Ann Card Anaesth. 2020 Apr-Jun;23(2):200-208. doi: 10.4103/aca.ACA_241_18.
Results Reference
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PubMed Identifier
24396082
Citation
de la Torre PA, Garcia PD, Alvarez SL, Miguel FJ, Perez MF. A novel ultrasound-guided block: a promising alternative for breast analgesia. Aesthet Surg J. 2014 Jan 1;34(1):198-200. doi: 10.1177/1090820X13515902. No abstract available.
Results Reference
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PubMed Identifier
15616047
Citation
McDonald SB, Jacobsohn E, Kopacz DJ, Desphande S, Helman JD, Salinas F, Hall RA. Parasternal block and local anesthetic infiltration with levobupivacaine after cardiac surgery with desflurane: the effect on postoperative pain, pulmonary function, and tracheal extubation times. Anesth Analg. 2005 Jan;100(1):25-32. doi: 10.1213/01.ANE.0000139652.84897.BD.
Results Reference
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PubMed Identifier
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Citation
Nasr DA, Abdelhamid HM, Mohsen M, Aly AH. The analgesic efficacy of continuous presternal bupivacaine infusion through a single catheter after cardiac surgery. Ann Card Anaesth. 2015 Jan-Mar;18(1):15-20. doi: 10.4103/0971-9784.148314.
Results Reference
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PubMed Identifier
30170012
Citation
Lee CY, Robinson DA, Johnson CA Jr, Zhang Y, Wong J, Joshi DJ, Wu TT, Knight PA. A Randomized Controlled Trial of Liposomal Bupivacaine Parasternal Intercostal Block for Sternotomy. Ann Thorac Surg. 2019 Jan;107(1):128-134. doi: 10.1016/j.athoracsur.2018.06.081. Epub 2018 Aug 28.
Results Reference
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Citation
Chin KJ, Versyck B, Pawa A. Ultrasound-guided fascial plane blocks of the chest wall: a state-of-the-art review. Anaesthesia. 2021 Jan;76 Suppl 1:110-126. doi: 10.1111/anae.15276.
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Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology

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