COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2020-02-06
Study Completion:2021-06-26
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT04333095

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age greater than 18 years
  2. 2. Undergoing a surgical procedure through mini- or full sternotomy.
  1. 1. Clinical instability
  2. 2. Allergic to liposomal bupivacaine solution or any of its ingredients
  3. 3. Maximum-allowed dosage of local analgesia will be exceeded by the injection amount of liposomal bupivacaine used in this study (\<50 kg).
  4. 4. BMI \>45
  5. 5. Pregnant or nursing
  6. 6. Chronic home opioid usage
  7. 7. Left Ventricular Ejection Fraction (LVEF) \< 30%
  8. 8. Low cardiac output requiring mechanical or inotropic support
  9. 9. End-stage renal disease
  10. 10. Cirrhosis

Contacts and Locations

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Baylor Research Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-02-06
Study Completion Date2021-06-26

Study Record Updates

Study Start Date2020-02-06
Study Completion Date2021-06-26

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiovascular Surgery
  • Pain, Postoperative
  • Block