Bupivacaine vs. Liposomal Bupivacaine for Postoperative Pain

Overseen By Roberta Johnson

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: The Cleveland Clinic

Must not be taking: Morphine

Disqualifiers: Pregnancy, Infection, Liver disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

196 Participants Needed

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

I have had lung surgery using small cuts or robotic assistance.

Exclusion Criteria

Previous participation in this study

Poorly controlled psychiatric disorders

My kidney function is severely reduced.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Treatment

Participants receive PECSII and serratus anterior plane blocks with either bupivacaine HCl plus liposomal bupivacaine or bupivacaine HCl plus saline

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of analgesia score

3 days

Postoperative day 3 assessment

Treatment Details

Interventions

• Bupivacaine
• Liposomal Bupivacaine

Trial Overview 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.

Participant Groups

Group I: Bupi HCl plus liposomal bupi Experimental Treatment 1 Intervention

PECSII/SAP blocks with bupivacaine HCl plus liposomal bupivacaine

Group II: Bupi HCl plus saline Active Control 1 Intervention

PECSII/SAP blocks with bupivacaine HCl plus preservative free normal saline

Bupivacaine is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in European Union as Marcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Approved in Canada as Sensorcaine for:

• Local anesthesia for surgery
• Acute pain management
• Spinal anesthesia

Who Is Running the Clinical Trial?

The Cleveland Clinic

Lead Sponsor

Trials

1,072

Recruited

1,377,000+