Pecto-Intercostal Fascial Plane Block Catheter Trial for Reduction of Sternal Pain
Unknown statusPhase 2, Phase 3NCT05054179
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Brief summary (from the registry)
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 details
- 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
- Conditions
- Cardiac Surgery
- Sternotomy
- Acute Pain
- Interventions
- Drug: Ropivacaine 0.2% Injectable Solution Bolus
- Other: Normal Saline Infusion
- Drug: Ropivacaine 0.2% Injectable Solution Infusion
- Sponsor
- University of British Columbia
- Start date
- 2022-09-07
- Primary completion
- 2024-01
- Sex
- All
- Age range
- from 19 Years
- Results posted
- No results posted in this snapshot
- Countries
- Canada
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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)
Canadian sites (1)
| Facility | City | Province |
|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia |
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT05054179