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

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.

Study Overview

• Status: Terminated
• Conditions: Post-operative Pain
• Intervention / Treatment: Procedure: Pectointercostal fascia blocks; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Phase 4

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2G3
      • Gerhardus Heart van Rensburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; This group of patients will undergo placement of US guided pectointercostal fascia blocks.	Procedure: Pectointercostal fascia blocks; 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.; Other Names: peripheral nerve block; regional anesthesia
Placebo Comparator: Placebo; 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.	Other: Placebo; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption	Cumulative opioid consumption in milligrams of morphine in the first 12 hours after surgery.	12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption in 24 hours	Amount of opioid consumed in 24 hours	24 hours post-operatively
Time to extubation	Time until ETT is removed post-operatively.	24 hours
Pain score	Pain score as reported using the numeric rating scale	Every 6 hours for 24 hours post-operatively
ICU length of stay	Length of stay in ICU	2 weeks
Surgical site infection rate	Until hospital discharge	4 weeks
Local anesthetic systemic toxicity effects	As evidenced by: tinnitus, perioral numbness, metallic taste	24 hours

Collaborators and Investigators

• Sponsor: University of Alberta
• Investigators: Principal Investigator: Wing Lam, University of Alberta

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Nielsen S, Degenhardt L, Hoban B, Gisev N. A synthesis of oral morphine equivalents (OME) for opioid utilisation studies. Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):733-7. doi: 10.1002/pds.3945. Epub 2015 Dec 22.

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2022
• Primary Completion (Actual): June 11, 2023
• Study Completion (Actual): June 11, 2023

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: November 22, 2021
• First Posted (Actual): December 6, 2021

Study Record Updates

• Last Update Posted (Actual): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: cardiac surgery; cardiac anesthesia; regional anesthesia; post-operative pain; sternotomy; pectointercoastal fascia block; fast-track cardiac surgery; truncal nerve block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: Pro00114968

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No