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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05054179
Enrollment
80
Registered
2021-09-23
Start date
2022-09-07
Completion date
2024-07-31
Last updated
2022-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Surgery, Sternotomy, Acute Pain

Keywords

Pecto-intercostal fascial plane catheters, Cardiac surgery, Heart surgery, Sternotomy, Acute pain, Post-sternotomy pain, Chronic Pain

Brief summary

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.

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.

Interventions

DRUGRopivacaine 0.2% Injectable Solution Bolus

20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side

3 mL/hour infusion of normal saline for 48 hours via parasternal multi-orifice catheters on each side of the sternum

DRUGRopivacaine 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

Sponsors

University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Patient Masking: Patients will be informed that they will receive one of two solutions (ropivacaine or saline) for infusion, without disclosing which group they are allocated to. Anesthesiologists, cardiac surgeons, Cardiac Surgery Intensive Care Unit (CSICU) nurses, ward nurses, nurse practitioners, and acute pain service team Masking: blinded/masked to assignments. Assessors Masking: Assessment of patients, data collection, and follow-up will be conducted by team members (i.e. research assistant, anesthesiologist, CSICU nurses, and ward nurses, acute pain service team) will be blinded/masked to group allocation of a patient participant. Data Analyst Masking: The data analysts will be provided a table with two groups of the unique numbers, but which group corresponds with ropivacaine and which corresponds with normal saline will not be revealed until the data analysis has been fully completed.

Intervention model description

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\) Intervention Group: 20 mL of ropivacaine 0.2% will be bolused through PIFB catheters on each side, followed by 3 mL/hour infusion of ropivacaine 0.2% for 48 hours each side. 2\) Control Group: 20 mL of ropivacaine 0.2% will be bolused through PIFB catheters on each side, followed by 3 mL/hour infusion of normal saline for 48 hours each side.

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. Preoperative

Design outcomes

Primary

MeasureTime frameDescription
Post-operative Sternal Pain on coughing at 24 hours.Post-surgery 24 hours after interventionCardiac 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.

Secondary

MeasureTime frameDescription
Post-operative sternal pain severityPost surgery, every 8 hours after intervention up to 48 hoursCardiac 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.
Nausea or vomitingPost-surgery within 48 hours of interventionAfter patient's discharge from hospital, medical record will be reviewed for nausea or vomiting and reported as yes or no.
Quality of Recovery-15 score (QoR-15)Pre-surgery (at enrolment) and Post-surgery at 48 hoursThe 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.
Cumulative opioid consumption (in IV morphine equivalents)Post-surgery at 24 and 48 hours after interventionAfter patient's discharge from hospital, medical record will be reviewed for opioid (in IV morphine equivalents) consumption history.
Quality of Life QuestionnairePre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospitalParticipants 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.
Overall Health (EQ-5D VAS)Pre-operatively (at enrolment), 48 hours after intervention and 3 and 6 months after discharge from hospitalParticipants 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.
Chronic sternal painPost-surgery at 3 months and 6 monthsAfter 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.

Countries

Canada

Contacts

Primary ContactNicola Edwards, MHA
nedwards@providencehealth.bc.ca778-870-5520
Backup ContactTim TH Jen, MD
tim.jen@ubc.ca

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026