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Pecto-Intercostal Fascial Block for Sternotomy Pain
Phase 2 & 3
Recruiting
Led By Ron Ree, MD
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adult (19 years old or older)
Complete median sternotomy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up post-surgery at 3 months and 6 months
Awards & highlights
Study Summary
This trial will compare two methods of managing post-sternotomy pain: injecting local anesthesia into the pecto inter-fascial plane vs. routine care (pain medication, ice, etc.).
Who is the study for?
This trial is for adults over 19 who've had a sternotomy during heart surgery, speak English, and are scheduled for cardiac surgery. They must be able to consent and follow up by phone. Excluded are those with coagulopathy not due to medication, uncontrolled diabetes, opioid tolerance, barriers to catheter placement like implants or skin disease at the site, severe liver or kidney failure, allergies to specific pain meds or local anesthetics.Check my eligibility
What is being tested?
The study tests if injecting local anesthesia repeatedly through catheters into the chest wall after open-heart surgery helps better manage pain compared to routine care. It involves two types of interventions: normal saline (a placebo) infusion and ropivacaine (an anesthetic) either as a continuous infusion or as single injections ('bolus').See study design
What are the potential side effects?
Ropivacaine may cause side effects such as low blood pressure, nausea, vomiting, dizziness or lightheadedness when standing up quickly. Rarely it can cause more serious issues like seizures or heart problems if absorbed into the bloodstream in high amounts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 19 years old or older.
Select...
I have had open-heart surgery through a cut down the center of my chest.
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I am scheduled for heart surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ post-surgery at 3 months and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~post-surgery at 3 months and 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Post-operative Sternal Pain on coughing at 24 hours.
Secondary outcome measures
Chronic sternal pain
Cumulative opioid consumption (in IV morphine equivalents)
Nausea or vomiting
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Intervention GroupExperimental Treatment2 Interventions
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.
Group II: Placebo groupPlacebo Group2 Interventions
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.
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Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,415 Previous Clinical Trials
2,466,936 Total Patients Enrolled
1 Trials studying Acute Pain
120 Patients Enrolled for Acute Pain
Ron Ree, MDPrincipal InvestigatorUniversity of British Columbia
1 Previous Clinical Trials
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a low platelet count before surgery.My surgery's pain management plan might not include a specific nerve block within 4 hours of ICU arrival.My kidney function is severely reduced.I did not lose more than 350 mL of blood through my chest tube after surgery.My weight is under 60 kg.I am not currently experiencing significant bleeding after surgery.My liver is severely damaged (Child-Pugh B or C).I am not currently experiencing significant bleeding after surgery.I am 19 years old or older.I don't have implants or devices that would interfere with catheter placement.I am not experiencing bleeding after surgery that requires more surgery to fix.I have had open-heart surgery through a cut down the center of my chest.I have a skin condition that could interfere with placing a catheter.I have a genetic disorder affecting my blood's ability to clot.Your blood clotting tests show abnormal results without taking any blood-thinning medicine.You have a weakened immune system, including uncontrolled diabetes with an HbA1C of 7.8% or higher.I have a known blood clotting disorder not related to my current medications.I will start blood thinners within 48 hours after surgery.You have a medical device or implant that could block the placement of a catheter.I am stable after surgery as determined by my care team.I am not expected to be on a breathing machine for more than a day after surgery.I am scheduled for heart surgery.I have been taking more than 60mg of morphine daily for over a week.I have not refused to participate in the preoperative procedures.I am not scheduled for emergency surgery.I can follow up with my doctor over the phone.I have a hereditary blood clotting disorder.You are allergic to certain pain medications or local anesthetics.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention Group
- Group 2: Placebo group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are common maladies that Ropivacaine 0.2% Injectable Solution is indicated for?
"Ropivacaine 0.2% Injectable Solution is used as a numbing agent for medical procedures such as surgery, childbirth, and post-operative pain management."
Answered by AI
What are we hoping to achieve by conducting this research?
"The aim of the study is to evaluate post-operative sternal pain in patients after surgery. This will be done by measuring the NRS sternal pain score on coughing, quality of life questionnaire, and cumulative opioid consumption."
Answered by AI
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