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

Sponsor

University of British Columbia (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05054179

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cardiac Surgery Sternotomy Acute Pain	Drug: Ropivacaine 0.2% Injectable Solution Other: Normal Saline	Phase 2/Phase 3

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:

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.
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 Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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.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: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.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.

Masking:

Quadruple (Participant, Care Provider, 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.

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jul 1, 2024

Arms and Interventions

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 20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side, followed by infusion of 3 mL/h for 48 hours after Sternotomy.
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 20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side, followed by infusion of 3 mL/h for 48 hours after Sternotomy. Other: Normal Saline 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.

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

20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side, followed by infusion of 3 mL/h for 48 hours after Sternotomy.

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

20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side, followed by infusion of 3 mL/h for 48 hours after Sternotomy.

Other: Normal Saline

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.

Outcome Measures

Primary Outcome Measures

Post-operative Sternal Pain on coughing at 24 hours. [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.

Secondary Outcome Measures

Cumulative opioid consumption (in IV morphine equivalents) [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-operative sternal pain severity [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.
Nausea or vomiting [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.
Quality of Recovery-15 score (QoR-15) [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.
Chronic sternal pain [Post-surgery at 3 months]
After patient's discharge from hospital, medical record will be reviewed for complications of sternal wound infection at 3 months post-surgery, (yes/no).

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Preoperative Exclusion Criteria:

Patient refusal
Emergent surgery
Inability to provide consent
Inability to follow up via telephone
Known preoperative coagulopathy i) Congenital coagulopathy ii) Congenital platelet disorders iii) Platelet count < 50 x 109 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
Predicted post-operative therapeutic anticoagulation within 48 hours.
Skin disease over block insertion site that would prevent catheter securement
Immunodeficiency including uncontrolled diabetes, as defined by HbA1C of 7.8% or more
Preoperative advanced liver failure (as defined by Child-Pugh B or C)
Preoperative advanced renal failure (as defined by Estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m2)
Opioid tolerance (as defined by morphine oral equivalent >60mg for a period of 7 days or longer pre-operatively)
Allergy to local anesthetic, acetaminophen, or hydromorphone
Weight less than 60 kg

Postoperative Exclusion Criteria:

Postoperative bleeding at time of randomization as defined by initial chest tube loss of >350 mL, >200 mL per hour loss, > 2 mL/kg/hour loss for 2 consecutive hours, 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 Pector-Intercostal Fascial Plane Block (PIFB) catheter within 4 hours of CSICU arrival