Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

Researchers hope to learn whether giving the longer-acting local anesthetic liposomal bupivacaine prior to closing the sternum is more effective in managing pain following sternotomy, than in patients who received standard bupivacaine before sternal closure. Researchers will measure this based on how much IV pain medication is used, rates on confusion, and time to remove the breathing tube.

Study Overview

• Status: Recruiting
• Conditions: Pain Management; Sternotomy
• Intervention / Treatment: Drug: Exparel; Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Angie Ballew, DC, MS; Phone Number: 9139457420; Email: aballew@kumc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Medical Center
      • Contact: Abigail Houchin; Email: ahouchin@kumc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Adults over the age of 18 who present for elective open heart surgery that requires a sternotomy.

Exclusion Criteria:

• Urgent and emergency procedures,
• preexisting sternal infections,
• prior sternotomy,
• preexisting pain syndromes,
• current chronic home opioid use,
• anterior rib or sternal masses,
• allergy to any of the components of liposomal bupivacaine and plain bupivacaine.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Liposomal bupivacaine; Exparel (266mg) given by surgeon just prior to sternal closure	Drug: Exparel; The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure
ACTIVE_COMPARATOR: Bupivacaine; 40ml of 0.125% bupivacaine given by surgeon just prior to sternal closure	Drug: Bupivacaine; The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	0 hours post-surgery
Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	12 hours post-surgery
Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	24 hours post-surgery
Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	36 hours post-surgery
Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	48 hours post-surgery
Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	60 hours post-surgery
Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	72 hours post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to extubation in minutes will be retrieved via the electronic medical record	Time to extubation in minutes will be retrieved via the electronic medical record	30 days post operative
Presence of sternal wound infection	Presence of sternal wound infection will be retrieved via electronic medical record and at 30 day follow up for Society of Thoracic Surgery (STS) database data as well as sternal infection documented at standard postoperative visit at 4-6 weeks	4-6 weeks postoperative visit
Postoperative delirium as assessed by Confusion Assessment Method (CAM)-ICU	Postoperative delirium as assessed by CAM-ICU at hours 0,12,24,36,48,60,and 72 hours post-surgery will be retrieved via the electronic medical record	30 days post operative

Collaborators and Investigators

• Sponsor: University of Kansas Medical Center
• Investigators: Principal Investigator: Jared Staab, DO, University of Kansas Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 11, 2017
• Primary Completion (ANTICIPATED): October 10, 2023
• Study Completion (ANTICIPATED): October 10, 2023

Study Registration Dates

• First Submitted: September 24, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 14, 2020
• Last Update Submitted That Met QC Criteria: October 12, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: STUDY00140472

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No