Recruiting
Phase 2
Phase 3

Pecto-Intercostal Block

Sponsor:

University of British Columbia

Code:

NCT05054179

Conditions

Cardiac Surgery

Sternotomy

Acute Pain

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Ropivacaine 0.2% Injectable Solution Bolus

Normal Saline Infusion

Ropivacaine 0.2% Injectable Solution Infusion

Study Details

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.

Conditions

Cardiac Surgery

Sternotomy

Acute Pain

Study ID

NCT05054179

Start date

Sep 7, 2022

Status verified date

Nov, 2022

Completion date

Jul, 2024

Anticipated

Primary completion date

Jan, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19+

Healthy Volunteers: Not accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Ropivacaine 0.2% Injectable Solution Bolus

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

Normal Saline Infusion

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

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

Primary outcome measure

  • Post-operative Sternal Pain on coughing at 24 hours. [ Time Frame: Post-surgery 24 hours after intervention ]

Central Contacts and Locations

Central contacts

Nicola Edwards, MHA

778-870-5520nedwards@providencehealth.bc.ca

Tim TH Jen, MD

tim.jen@ubc.ca

Locations

St. Paul's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6Z 1Y6

Contacts

Nicola Edwards, MHA

778-870-5520nedwards@providencehealth.bc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Nov 4, 2022

Last verified

Nov, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2022-11-04.