Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain

November 1, 2022 updated by: Ron Ree, University of British Columbia

The Efficacy of Pecto-intercostal Fascial Plane Catheters for Reduction of Sternal Pain in Cardiac Surgery Patients With Complete Median Sternotomy: A Randomized, Placebo-controlled Trial

One of the most painful aspects of open heart surgery is the incision made through the skin and the sternum to access the heart (a "sternotomy"). Post-sternotomy pain is a potentially debilitating complication of surgery that slows recovery immediately after surgery and can lead to issues with chronic pain. Previous research has shown that by injecting local anesthesia in the pecto inter-fascial plane, the space between the pectoralis major and the intercostal muscles, pain relief can be provided. The investigators aim to assess if repeated injections of local anesthesia via catheters is a useful adjunct compared to routine care.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Justification:

Post-sternotomy pain after cardiac surgery can be debilitating, with associated risks of decreased respiratory function and chronic pain. Severe acute sternal pain after cardiac surgery occurs in 49% of patients at rest and 78% of patients during coughing. Post-sternotomy pain is worst during the first two days and improves thereafter.

The sternum is innervated by the medial division of the anterior cutaneous branches of the T2-6 intercostal nerves, which may be targeted by several regional anesthetic techniques. Concerns of rare epidural hematoma and possible case cancellations with a bloody tap, in the context of systemic heparinization for cardiac surgery, deters many from utilizing neuraxial analgesia for post-sternotomy pain. Contrarily, parasternal regional blocks such as pecto-intercostal fascial plane block (PIFB) provide a low-risk alternative that targets the anterior cutaneous branches of intercostal nerves, and PIFB has been shown to be effective in improving acute post-sternotomy pain.

Nevertheless, single-shot PIFB is limited by its short duration of action, whereas sternotomy pain can remain severe for two postoperative days. Hence, continuous local anesthetic infusion via bilateral PIFB catheters for 48 hours may improve patient pain experience and related outcomes over single shot PIFB.

Objective:

This study aims to evaluate whether, in addition to single shot PIFB, continuous local anesthetic infusion (compared with placebo infusion) through bilateral PIFB catheters reduces acute sternal pain at 24 hours after cardiac surgery with complete median sternotomy. The 24-hour time point was chosen as it represents a time where both the post-sternotomy pain is rated as severe, especially with movement and coughing, and the patient is required to start actively participating in the postoperative rehabilitative process.

Hypotheses:

This study hypothesize that, in addition to single shot PIFB, continuous ropivacaine infusion through bilateral PIFB catheters will be more effective than placebo infusion in reducing sternal pain score on standardized coughing at 24 hours after cardiac surgery with complete median sternotomy.

Study Design:

This will be a prospective, randomized, triple-blinded, placebo-controlled trial in which patients will be randomly allocated to two study groups on a 1:1 basis into:

1) Treatment Group: 20 mL of ropivacaine 0.2% will be deposited via parasternal multi-orifice catheters on each side, followed by infusion of 3 mL/h for 48 hours.

2) Control Group: 20 mL of ropivacaine 0.2% will be deposited via parasternal multi-orifice catheters on each side, followed by a saline infusion of 3 mL/h for 48 hours.

Study Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled cardiac surgery patients
  • Complete median sternotomy
  • Adult (19 years old or older)
  • English-speaking

Exclusion Criteria:

  1. Preoperative Exclusion Criteria:

    • Patient refusal
    • Emergent surgery
    • Inability to provide consent
    • Expected inability to follow up via telephone

    • Known preoperative coagulopathy

      i) Congenital coagulopathy ii) Congenital platelet disorders iii) Platelet count < 50 x 10^9 iv) International normalized ratio (INR) or activated partial thromboplastin time (aPTT) exceeding the upper range of normal in the absence of anticoagulant use v) Does not include active anticoagulant or antiplatelet use

    • Known predicted post-operative therapeutic anticoagulation within 48 hours.
    • Known skin disease over block insertion site that would prevent catheter securement
    • Known Immunodeficiency including uncontrolled diabetes, as defined by HbA1C of 7.8% or more
    • Known preoperative advanced liver failure (as defined by Child-Pugh B or C)
    • Known preoperative advanced renal failure (as defined by Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2)
    • Known opioid tolerance (as defined by morphine oral equivalent >60mg for a period of 7 days or longer pre-operatively)
    • Known allergy to local anesthetic, acetaminophen, or hydromorphone
    • Known weight less than 60 kg
    • Any known technical or physical barrier to block catheter placement (i.e., deep brain stimulation pulse generator or other devices, breast or other implants)

  2. Postoperative Exclusion Criteria:

    • Postoperative bleeding at time of randomization as defined by:

      i) initial chest tube loss of >350 mL ii) >200 mL per hour loss iii) > 2 mL/kg/hour loss for 2 consecutive hours iv) or requiring return to the operating room for surgical management

    • Hemodynamic instability, as determined by Cardiac Surgery Intensive Care Unit (CSICU) attending anesthesiologist
    • Anticipated mechanical ventilation of more than 24 hours
    • Anesthesiologist unavailable to insert Pecto-Intercostal Fascial Plane Block (PIFB) catheter within 4 hours of CSICU arrival
    • Any known technical or physical barrier to block catheter placement (i.e., deep brain stimulation pulse generator or other devices, breast or other implants)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The participants of this group will receive 20 mL of 0.2% Ropivacaine via parasternal multi-orifice catheters on each side of the sternum, followed by infusion of 3 mL/h for 48 hours.
Drug: Ropivacaine 0.2% Injectable Solution Bolus
20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side
Drug: Ropivacaine 0.2% Injectable Solution Infusion
3 mL/h infusion of Ropivacaine 0.2% for 48 hours via parasternal multi-orifice catheters on each side of the sternum
Placebo Comparator: Placebo group
The participants of this group will receive 20 mL of 0.2% Ropivacaine via parasternal multi-orifice catheters on each side of the sternum, followed by infusion of 3 mL/h of normal saline for 48 hours.
Drug: Ropivacaine 0.2% Injectable Solution Bolus
20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side
Other: Normal Saline Infusion
3 mL/hour infusion of normal saline for 48 hours via parasternal multi-orifice catheters on each side of the sternum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative Sternal Pain on coughing at 24 hours.
Time Frame: Post-surgery 24 hours after intervention

Cardiac Surgery Intensive Care Unit nurses or recovery ward nurses will assess and record Numeric Rating Scale (NRS) sternal pain scores on coughing. Coughing will be elicited with a standardized script for a sitting patient:

"Please use both hands to hold on to the pillow in front of you to hold your chest in. Take a deep breath in, and give me three coughs in a row"

The scale is from 0 to 10, with 0 being no pain at all and 10 being the worst pain possible.
Post-surgery 24 hours after intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative opioid consumption (in IV morphine equivalents)
Time Frame: Post-surgery at 24 and 48 hours after intervention
After patient's discharge from hospital, medical record will be reviewed for opioid (in IV morphine equivalents) consumption history.
Post-surgery at 24 and 48 hours after intervention
Post-operative sternal pain severity
Time Frame: Post surgery, every 8 hours after intervention up to 48 hours

Cardiac Surgery Intensive Care Unit nurses or recovery ward nurses will assess and record Numeric Rating Scale (NRS) sternal pain scores at rest and on coughing up to 48 hours after the intervention.

Coughing will be elicited with a standardized script for a sitting patient:

"Please use both hands to hold on to the pillow in front of you to hold your chest in. Take a deep breath in, and give me three coughs in a row".

The scale is from 0 to 10, with 0 being no pain at all and 10 being the worst pain possible.

These scores will be recorded every 8 hours.
Post surgery, every 8 hours after intervention up to 48 hours
Nausea or vomiting
Time Frame: Post-surgery within 48 hours of intervention
After patient's discharge from hospital, medical record will be reviewed for nausea or vomiting and reported as yes or no.
Post-surgery within 48 hours of intervention
Quality of Recovery-15 score (QoR-15)
Time Frame: Pre-surgery (at enrolment) and Post-surgery at 48 hours
The research assistant/research coordinator will administer Quality of Recovery-15 score (QoR-15). The QoR-15 includes Part A and Part B. Part A consists of 10 questions regarding how the patient has been feeling in the last 24 hours on a 11-point likert scale from 0 to 10, with 0 being "None of the time" and 10 being "All of the time". Part B consists of 5 questions regarding if the patient has had any of the following in the last 24 hours on the same scale as Part A.
Pre-surgery (at enrolment) and Post-surgery at 48 hours
Chronic sternal pain
Time Frame: Post-surgery at 3 months and 6 months
After patient's discharge from hospital, they will be called at 3 months and 6 months post-surgery and asked about their sternal pain severity on a numeric rating scale of 0-10.
Post-surgery at 3 months and 6 months
Quality of Life Questionnaire
Time Frame: Pre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospital
Participants will complete a quality of life questionnaire, the EQ-5D-5L, preoperatively, at 48 hours, 3 months and 6 months. The first two assessments will be done in person, the 3 and 6 month follow-ups will be done over the phone. The questionnaire consists of 5 dimensions of life (Mobility, Self-Care, Usual Activities, Pain and Discomfort, and Anxiety/Depression). Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Pre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospital
Overall Health (EQ-5D VAS)
Time Frame: Pre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospital
Participants will report their overall health rating using the EQ-5D Visual Analog Scale (0-100, with 0 being the worst health you can imagine and 100 being the best health you can imagine). This is done preoperatively, at 48 hours, 3 months and 6 months. The first two assessments will be done in person, the 3 and 6 month follow-ups will be done over the phone.
Pre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Ron Ree, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2022

Primary Completion (Anticipated)

January 1, 2024

Study Completion (Anticipated)

July 1, 2024

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

September 20, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

November 4, 2022

Last Update Submitted That Met QC Criteria

November 1, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIFB Catheter RCT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Individual participant data (IPD) will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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