Bupivacaine vs. Liposomal Bupivacaine for Postoperative Pain
Trial Summary
What is the purpose of this trial?
Patients will be randomized the day of surgery upon presentation to the operating room to either a treatment group (PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine) or a control group (PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline) using secure web-based randomization. Assignments will be based on computer-generated code. Clinicians will not be blinded to the intervention, but all outcomes will be assessed by research personnel who are blinded to the group assignment.
Research Team
Alparslan Turan, MD
Principal Investigator
The Cleveland Clinic
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive PECSII and serratus anterior plane blocks with either bupivacaine HCl plus liposomal bupivacaine or bupivacaine HCl plus saline
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of analgesia score
Treatment Details
Interventions
- Bupivacaine
- Liposomal Bupivacaine
Bupivacaine is already approved in United States, European Union, Canada for the following indications:
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
- Local anesthesia for surgery
- Acute pain management
- Spinal anesthesia
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor