Pectoral-Intercostal Fascial Plane Block Study

NCT03729635 | Completed

• 1 other identifier: H17-03322
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Pain along the sternum following opening of the chest cavity, also known as post-sternotomy pain (PSP), is a common complication after heart surgery that is associated with several negative side effects. Unfortunately, an effective and safe treatment has not yet been discovered for PSP. However, recently a regional anesthesia technique called the pecto-intercostal fascial block (PIFB) was found to be associated with improved pain relief for breast surgery. The investigators plan to assess the feasibility of using PIFB as an effective and safe treatment for PSP.

Conditions

Anesthesia, Regional; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Feasibility of PIFB in reduction of PSP following Sternotomy

  Defined as successful reduction of NPRS by 2 or more points

  Baseline to 30 minutes post-block completion

Secondary Outcomes (13)

• Numeric pain rating score (NPRS)

  Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block)

• Opioid and analgesic use

  24 hours after block or until discharge from Cardiac Surgery Intensive Care Unit (CSICU) (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block)

• Duration of block

  Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block)

• Blood pressure

  Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block)

• Vasopressor medications administered

  Baseline to 24 hours after block or until discharge from CSICU (data collection times: at 5, 10, 20, 30 minutes, 1 hour, 2 hours and every 2 hours after that from time of block)

Study Arms (1)

PIFB performed to treat PSP

EXPERIMENTAL

Pectoral-intercostal fascial plane block (PIFB) is performed on patients with severe post-sternotomy pain (PSP) after coronary artery bypass graft surgery (CABG).

Procedure: Pectoral-intercostal fascial plane block (PIFB)

Interventions

Pectoral-intercostal fascial plane block (PIFB) PROCEDURE

Local anesthetic is infiltrated into the fascial plane between pectoralis major and the intercostal muscles lateral to the sternum to anesthetize the anterior cutaneous branches of the intercostal nerves.

PIFB performed to treat PSP

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing a CABG and/or valve Surgery.
• Extubated and on no assisted ventilation
• NPRS equal to or greater than 5 related to sternal pain despite standard treatment
• Aged 19-80
• American Society of Anesthesiologists Physical Status Classification System 1 to 4 (ASA I-IV)
• Provided written informed consent
• Body Mass Index \< 35 kg/m\^2
• Patient weight equal to or greater than 50 kg
• CAM negative and RASS of +1 (restless) to -2 (light sedation)

You may not qualify if:

• A known history or allergy, sensitivity, or any other form of reaction to amide-type local anesthetics.
• Suspected inability to comply with study procedures, including language difficulties, or medical history and/or concomitant disease, as judged by the investigator.
• A neurological and/or vascular condition which may preclude eligibility for peripheral nerve blockade as judged by the investigator.
• Coagulopathy
• Participation in other clinical studies during this study or in the 14 days prior to admission to this study.
• Neuromuscular disease
• Thoracotomy
• Mini-Sternotomy

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Related Publications (13)

• Lahtinen P, Kokki H, Hynynen M. Pain after cardiac surgery: a prospective cohort study of 1-year incidence and intensity. Anesthesiology. 2006 Oct;105(4):794-800. doi: 10.1097/00000542-200610000-00026.

  PMID: 17006079 BACKGROUND

• Huang AP, Sakata RK. Pain after sternotomy - review. Braz J Anesthesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjane.2014.09.013. Epub 2016 Apr 23.

  PMID: 27343790 BACKGROUND

• Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.

  PMID: 21955825 BACKGROUND

• Brown JR, Cochran RP, MacKenzie TA, Furnary AP, Kunzelman KS, Ross CS, Langner CW, Charlesworth DC, Leavitt BJ, Dacey LJ, Helm RE, Braxton JH, Clough RA, Dunton RF, O'Connor GT; Northern New England Cardiovascular Disease Study Group. Long-term survival after cardiac surgery is predicted by estimated glomerular filtration rate. Ann Thorac Surg. 2008 Jul;86(1):4-11. doi: 10.1016/j.athoracsur.2008.03.006.

  PMID: 18573389 BACKGROUND

• Barr AM, Tutungi E, Almeida AA. Parasternal intercostal block with ropivacaine for pain management after cardiac surgery: a double-blind, randomized, controlled trial. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):547-53. doi: 10.1053/j.jvca.2006.09.003. Epub 2006 Dec 22.

  PMID: 17678782 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

• 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

• Warner L, Ritter MJ. 2017. Bilateral Pecto-Intercostal Fascial Plane Block for Acute Relief of Post-Sternotomy Pain. Scientific Abstracts and ePosters: ASRA 42nd Annual Regional Anesthesiology and Acute Pain Medicine Meeting April 6-8, 2017 San Francisco, CA. Reg Anesth Pain Med. 2017; 42 (6): 802-818.

  BACKGROUND

• Liu V, Mariano ER, Prabhakar C. Pecto-intercostal Fascial Block for Acute Poststernotomy Pain: A Case Report. A A Pract. 2018 Jun 15;10(12):319-322. doi: 10.1213/XAA.0000000000000697.

  PMID: 29293481 BACKGROUND

• Scientific Abstracts and ePosters: ASRA 42nd Annual Regional Anesthesiology and Acute Pain Medicine Meeting April 6-8, 2017 San Francisco, CA. Reg Anesth Pain Med. 2017; 42 (6): 802-818.

  BACKGROUND

• Del Buono R, Costa F, Agro FE. Parasternal, Pecto-intercostal, Pecs, and Transverse Thoracic Muscle Plane Blocks: A Rose by Any Other Name Would Smell as Sweet. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):791-792. doi: 10.1097/AAP.0000000000000464. No abstract available.

  PMID: 27776103 BACKGROUND

• Julious, SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceut Statist. 2005;4:287-291.

  BACKGROUND

• Moore CG, Carter RE, Nietert PJ, Stewart PW. Recommendations for planning pilot studies in clinical and translational research. Clin Transl Sci. 2011 Oct;4(5):332-7. doi: 10.1111/j.1752-8062.2011.00347.x.

  PMID: 22029804 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Officials

• Anton Chau, MD

  University of British Columbia

  STUDY CHAIR

• Kevin Rondi, MD

  University of British Columbia

  STUDY CHAIR

• Simon Bruce, MD

  University of British Columbia

  STUDY CHAIR

• James Abel, MD

  University of British Columbia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: May 1, 2018
• First Posted: November 5, 2018
• Study Start: June 1, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: April 17, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)