Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

Phase 1

• Conditions: Sternotomy; Pain Management
• Interventions: Drug: Exparel; Drug: Bupivacaine

• Registration Number: NCT04585867
• Lead Sponsor: University of Kansas Medical Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-11
• Study First Submitted: 2020-09-24
• Status Verified: 2020-10
• Study First Submitted QC: 2020-10-12
• Last Update Submitted: 2020-10-12
• Study First Posted: 2020-10-14
• Last Update Posted: 2020-10-14
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal bupivacaine	Exparel	Exparel (266mg) given by surgeon just prior to sternal closure
Bupivacaine	Bupivacaine	40ml of 0.125% bupivacaine given by surgeon just prior to sternal closure

Primary Outcome Measures

Name	Time	Method
Opioid consumption in morphine equivalents	72 hours post-surgery	Opioid consumption in morphine equivalents

Secondary Outcome Measures

Name	Time	Method
Time to extubation in minutes will be retrieved via the electronic medical record	30 days post operative	Time to extubation in minutes will be retrieved via the electronic medical record
Postoperative delirium as assessed by Confusion Assessment Method (CAM)-ICU	30 days post operative	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
Presence of sternal wound infection	4-6 weeks postoperative visit	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

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States