Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology

NCT05146453 | Terminated Phase 4

• 1 other identifier: Pro00114968
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-operative Pain

Keywords

sternotomy; regional anesthesia; pectointercoastal fascia block; fast-track cardiac surgery; post-operative pain; truncal nerve block; cardiac surgery; cardiac anesthesia

Outcome Measures

Primary Outcomes (1)

• Opioid consumption

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

  12 hours

Secondary Outcomes (6)

• Opioid consumption in 24 hours

  24 hours post-operatively

• Time to extubation

  24 hours

• Pain score

  Every 6 hours for 24 hours post-operatively

• ICU length of stay

  2 weeks

• Surgical site infection rate

  4 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Procedure: Pectointercostal fascia blocks

Placebo

PLACEBO COMPARATOR

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

Interventions

Pectointercostal fascia blocks PROCEDURE

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.

Also known as: peripheral nerve block, regional anesthesia

Intervention

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Gerhardus Heart van Rensburg

Edmonton, Alberta, T6G 2G3, Canada

Location

Related Publications (10)

• 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.

  PMID: 32032103 BACKGROUND

• 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.

  PMID: 31360703 BACKGROUND

• 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.

  PMID: 34022969 BACKGROUND

• 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.

  PMID: 32275036 BACKGROUND

• 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.

  PMID: 24396082 BACKGROUND

• 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.

  PMID: 15616047 BACKGROUND

• 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.

  PMID: 25566704 BACKGROUND

• 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.

  PMID: 30170012 BACKGROUND

• 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.

  PMID: 33426660 BACKGROUND

• 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.

  PMID: 26693665 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Anesthesia, Conduction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Wing Lam

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: December 6, 2021
• Study Start: September 22, 2022
• Primary Completion: June 11, 2023
• Study Completion: June 11, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)