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

NCT05054179 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2022-11-04

No results posted yet for this study

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

Interventions

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

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

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Ron Ree, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-07
Primary Completion
2024-01-31
Completion
2024-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05054179 on ClinicalTrials.gov