Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

University of Kansas

Status and phase: Unknown; Phase 1

Conditions: Pain Management; Sternotomy

Treatments: Drug: Exparel; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT04585867

STUDY00140472

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 2 patient groups

Liposomal bupivacaine

Active Comparator group

Description:

Exparel (266mg) given by surgeon just prior to sternal closure

Treatment:

Drug: Exparel

Bupivacaine

Active Comparator group

Description:

40ml of 0.125% bupivacaine given by surgeon just prior to sternal closure

Treatment:

Drug: Bupivacaine