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Local Anesthetic
Bupivacaine vs. Liposomal Bupivacaine for Postoperative Pain
Phase < 1
Waitlist Available
Led By Alparslan Turan, MD
Research Sponsored by The Cleveland Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Procedures using thoracic access ports or miniature thoracotomy incisions such as video assisted thoracic surgical (VATS) or robotic anatomic pulmonary resection (lobectomy, bilobectomy, and segmentectomy)
Patients 18-85 years of age
Timeline
Screening 3 weeks
Treatment Varies
Follow Up postoperative day 3
Awards & highlights
Study Summary
This trial is testing whether adding liposomal bupivacaine to regular bupivacaine for PECSII/SAP blocks results in better pain relief for patients.
Who is the study for?
This trial is for adults aged 18-85 undergoing certain thoracic surgeries like VATS or robotic pulmonary resection. Candidates must not be on high doses of opioids, have active liver disease, pacemakers or implants near the surgery site, weigh under 50 kg, be pregnant or breastfeeding, require emergency surgery from ICU, have severe kidney issues, infections, uncontrolled psychiatric disorders or known allergies to local anesthetics.Check my eligibility
What is being tested?
The study compares pain management in thoracic surgery patients using two types of blocks: one with bupivacaine HCl and liposomal bupivacaine (treatment group) versus bupivacaine HCl with saline (control group). Participants are randomly assigned to groups and outcome assessments are done by researchers unaware of which group each patient is in.See study design
What are the potential side effects?
Potential side effects may include reactions at the injection site such as discomfort or infection. Bupivacaine can cause nerve damage if improperly administered. Liposomal bupivacaine might prolong numbness due to its extended release but has similar risks as regular bupivacaine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had lung surgery using small cuts or robotic assistance.
Select...
I am between 18 and 85 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ postoperative day 3
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~postoperative day 3
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall benefit of analgesia score
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Bupi HCl plus liposomal bupiExperimental Treatment1 Intervention
PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine
Group II: Bupi HCl plus salineActive Control1 Intervention
PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline
Find a Location
Who is running the clinical trial?
The Cleveland ClinicLead Sponsor
1,026 Previous Clinical Trials
1,365,880 Total Patients Enrolled
Alparslan Turan, MDPrincipal InvestigatorThe Cleveland Clinic
7 Previous Clinical Trials
5,128 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had lung surgery using small cuts or robotic assistance.My kidney function is severely reduced.I was moved from the ICU to the operating room for emergency surgery.I have a significant current nerve or spinal cord issue.I expect to be on a breathing machine for more than a day.I have had a nerve block for chest pain relief.I do not have an ongoing infection affecting my whole body or heart/lungs.I have been taking more than 15 mg of pain medication daily for at least half of the last month.I weigh less than 50 kg.I have had or will need a second chest surgery or procedure within 3 days of my first one.I have active liver disease or cirrhosis.I am between 18 and 85 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Bupi HCl plus saline
- Group 2: Bupi HCl plus liposomal bupi
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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