Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery

Description

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.

Conditions

Cardiovascular Surgery, Pain, Postoperative, Block

Study Overview

Study Details

Study overview

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.

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

Sternal Block With Liposomal Bupivacaine vs. Saline Prior to Incision in Cardiac Surgery

Condition
Cardiovascular Surgery
Intervention / Treatment

-

Contacts and Locations

Plano

Baylor Scott & White Heart Hospital - Plano, Plano, Texas, United States, 75093

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age greater than 18 years
  • 2. Undergoing a surgical procedure through mini- or full sternotomy.
  • 1. Clinical instability
  • 2. Allergic to liposomal bupivacaine solution or any of its ingredients
  • 3. Maximum-allowed dosage of local analgesia will be exceeded by the injection amount of liposomal bupivacaine used in this study (\<50 kg).
  • 4. BMI \>45
  • 5. Pregnant or nursing
  • 6. Chronic home opioid usage
  • 7. Left Ventricular Ejection Fraction (LVEF) \< 30%
  • 8. Low cardiac output requiring mechanical or inotropic support
  • 9. End-stage renal disease
  • 10. Cirrhosis

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Baylor Research Institute,

Study Record Dates

2021-06