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Bupivacaine vs BKK Combination for Pain Management After CIED Procedures
Phase 1
Waitlist Available
Led By Dhanunjaya Lakkireddy, MD
Research Sponsored by Kansas City Heart Rhythm Research Foundation
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 until 7 days (until the end of the sutdy)
Awards & highlights
Study Summary
This trial will test the effectiveness of BKK compared to bupivacaine alone in patients undergoing CIED implant procedures.
Who is the study for?
This trial is for adults over 18 who are getting a new cardiac implantable electronic device (like an ICD or pacemaker) and want to participate. It's not for pregnant/breastfeeding individuals, prisoners, those under 18, anyone allergic to the drugs being tested, or patients considered unstable for the study.Check my eligibility
What is being tested?
The study is testing if a mix of Bupivacaine-Ketorolac-Ketamine (BKK) can better manage pain during and after surgery compared to just Bupivacaine alone in patients receiving heart-related implants.See study design
What are the potential side effects?
Possible side effects may include discomfort at the injection site, nausea, dizziness from Bupivacaine; stomach issues and bleeding risk from Ketorolac; and altered mental state or hallucinations from Ketamine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ until 7 days (until the end of the sutdy)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~until 7 days (until the end of the sutdy)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bupivacaine
Bupivacaine
Bupivacaine
Secondary outcome measures
Adverse Effects
Pharmaceutical Preparations
Cost comparison of medications
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Bupivacaine-Ketorolac-Ketamine (BKK) CombinationExperimental Treatment1 Intervention
This is the intervention group of patients receiving 20 cc combination of BKK (Bupivacaine HCl 60 mg [3 mg/mL], Ketorolac Tromethamine 24 mg [1.2mg/mL], Ketamine HCl 24 mg [1.2 mg/mL]).The dose and number of doses of the medicines will be adjusted as per discretion of the operator.
Group II: Bupivacaine AloneExperimental Treatment1 Intervention
This is the control group of patients receiving 20 cc of 0.5% bupivacaine (Bupivacaine HCL 100 mg [5mg/ml] alone. The dose and number of doses of the medicines will be adjusted as per discretion of the operator.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Kansas City Heart Rhythm Research FoundationLead Sponsor
26 Previous Clinical Trials
11,772 Total Patients Enrolled
Cardiac Arrhythmia Service, Loma Linda University Health, Loma Linda, CAUNKNOWN
Dhanunjaya Lakkireddy, MDPrincipal InvestigatorKansas City Heart Rhythm Institute
28 Previous Clinical Trials
8,024 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to participate in the study.I am under 18 years old.I am not willing to participate in the study.I am either male or female.I am older than 18 years.I have no allergies to bupivacaine, ketorolac, or ketamine.
Research Study Groups:
This trial has the following groups:- Group 1: Bupivacaine Alone
- Group 2: Bupivacaine-Ketorolac-Ketamine (BKK) Combination
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Pain Management Patient Testimony for trial: Trial Name: NCT05575999 — Phase 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the Bupivacaine-Ketorolac-Ketamine (BKK) Combination attained FDA authorization?
"Due to the limited data supporting its safety and efficacy, Bupivacaine-Ketorolac-Ketamine (BKK) Combination received a score of 1 out of 3 when evaluated by Power's team."
Answered by AI
Are new participants allowed to join the current clinical trial?
"The information on clinicaltrials.gov suggests this trial is no longer actively searching for volunteers; the initial post was published on January first 2023, and it has not been updated since November 15th 2022. Despite this, 33 other studies are currently enrolling individuals."
Answered by AI
What results does this exploration intend to prove?
"This clinical trial, which is expected to last up to a week, aims to compare the efficacy of BKK with bupivacaine alone in mitigating pain intensity. Secondary objectives include analyzing cost comparison for medications administered, determining potential adverse effects such as allergic reactions or drug-drug interactions, and comparing hospital readmission rates due to device implantation related pains or surgical site infection."
Answered by AI
Who else is applying?
What state do they live in?
Utah
California
What site did they apply to?
Loma Linda University Health
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
2
3+
Why did patients apply to this trial?
I am looking for different alternative to my pain. Have herniated C-5 C6 C7 in neck. Plus I need extra money.
PatientReceived 2+ prior treatments
I feel as though I’m a good candidate for any trial I am in optimal health and my body is very good with anything that’s been thrown at it in life as well as in previous trials which I had done some time ago.
PatientReceived 2+ prior treatments
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