Regional Blockade of the Sternum With Liposomal Bupivacaine Prior to Incision Decreases Opioid Use in Patients Undergoing Cardiac Surgery (Sternal Block)

Who is this study for? Patients undergoing cardiac surgery
What treatments are being studied? Bupivacaine
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
SUMMARY

The purpose of this study is to find out what effects (good and bad) that the study medicine called liposomal bupivacaine has on subjects that are undergoing a sternotomy. Liposomal bupivacaine solution, is a drug that the doctor will inject before they make the cut through patient's breastbone (sternotomy). Normally pain medicine like this is given right before the surgeon closes up the patient's breastbone, at the end of the surgery. For this study, they want to see if giving the medicine before they make the cut into the patient's breastbone helps their pain. They also want to find out if patients feel less pain after surgery with the study drug than they do with saline and possibly decrease the need for pain medicine. Subjects will be in the study for about 72 hours or until they are discharged from the hospital.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age greater than 18 years

• Undergoing a surgical procedure through mini- or full sternotomy.

Locations
United States
Texas
Baylor Scott & White Heart Hospital - Plano
Plano
Time Frame
Start Date: 2020-02-06
Completion Date: 2021-06-26
Participants
Target number of participants: 70
Treatments
Active_comparator: Liposomal Bupivacaine Block
Liposomal Bupivacaine (1.3%) solution (20 mL dose). This solution has demonstrated increased efficacy in prolonged analgesia following injection. This solution will be injected as an ultrasound-guided subpectoral interfacial plane block.
Placebo_comparator: Saline Block
Normal saline (0.9%) will be used as the control solution for patients not receiving the liposomal bupivacaine solution. Injection procedure of this solution will be identical to that of the liposomal bupivacaine solution.
Related Therapeutic Areas
Sponsors
Leads: Baylor Research Institute

This content was sourced from clinicaltrials.gov