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ABC Block for Postoperative Pain
Phase 4
Waitlist Available
Led By Michael Manning, MD
Research Sponsored by Duke University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 hours post-extubation
Awards & highlights
Study Summary
This trial will study how a type of pain block affects recovery after heart surgery. Subjects will receive either the block or a dummy block.
Who is the study for?
This trial is for adults aged 18-85 undergoing elective cardiac surgery via median sternotomy, with a BMI of 18-50 kg/m2. It's not suitable for those with severe lung disease, very weak heart function (LVEF <30%), certain pre/post-operative conditions, drug or alcohol abuse history, chronic opioid use, amide anesthetic allergy, or major psychiatric disorders.Check my eligibility
What is being tested?
The study tests the effectiveness of ABC blocks in pain management after cardiac surgery. Participants will be randomly assigned to receive either a local anesthetic (bupivacaine plus liposomal bupivacaine) or a saline sham block to compare recovery outcomes.See study design
What are the potential side effects?
Possible side effects may include discomfort at the injection site, allergic reactions to the anesthetics used in the ABC blocks such as itching or rash, and less commonly nerve damage which could cause weakness or numbness.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 hours post-extubation
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 hours post-extubation
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Tracheal Extubation
Secondary outcome measures
Tracheal Extubation
ICU length of stay
Time from end of case to tracheal extubation
+5 moreTrial Design
2Treatment groups
Active Control
Placebo Group
Group I: ABC block with bupivacaine and liposomal bupivacaineActive Control1 Intervention
The study solution used in the active arm will comprise 20 mL of liposomal bupivacaine (266 mg) admixed with 40 mL of 0.25% bupivacaine HCl. The solution will be administered as bilateral parasternal blocks (40 mL) and bilateral epigastric rectus sheath blocks (20 mL).
Group II: ABC block with salinePlacebo Group1 Intervention
The study solution used in the active arm will comprise 60 mL of 0.9% saline. The solution will be administered as bilateral parasternal blocks (40 mL) and bilateral epigastric rectus sheath blocks (20 mL).
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Who is running the clinical trial?
Duke UniversityLead Sponsor
2,358 Previous Clinical Trials
3,420,019 Total Patients Enrolled
25 Trials studying Pain
8,791 Patients Enrolled for Pain
Michael Manning, MDPrincipal InvestigatorDuke University
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your body mass index (BMI) is between 18 and 50, which means you are within a healthy weight range for your height.You have a problem with your brain or nervous system that affects how your body works.You have a history of using illegal drugs, misusing prescription medications, or excessive alcohol consumption within the past two years.You are allergic to certain types of local anesthesia.You have severe mental health conditions like uncontrolled anxiety, schizophrenia, or other serious psychiatric disorders.
Research Study Groups:
This trial has the following groups:- Group 1: ABC block with bupivacaine and liposomal bupivacaine
- Group 2: ABC block with saline
Awards:
This trial has 2 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Is the upper age limit for participants in this investigation greater than 35?
"According to the inclusionary criteria, acceptable applicants for this trial must have an age between 18 and 85. Separately, there are 71 studies that focus on those under 18 years old or 248 trials specifically targeting patients above 65."
Answered by AI
Is recruitment of participants still underway for this experiment?
"This research study, initially published on November 1st 2022 and last updated on October 18th of the same year, is not currently recruiting participants. However, there are 344 additional trials that are actively looking for willing volunteers."
Answered by AI
Which patient population has been deemed fit to participate in this clinical experiment?
"The criteria for this study necessitates that applicants have pain, and be between 18 to 85 years old. A total of 50 people will be invited to join the clinical trial."
Answered by AI
What potential risks do ABC block with bupivacaine and liposomal bupivacaine pose to patients?
"The safety rating of ABC block with bupivacaine and liposomal bupivacaine has been assessed as a 3, given that it is currently listed in Phase 4 clinical trials which signals an approval from regulatory agencies."
Answered by AI
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