Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

NCT ID: NCT04585867

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-11
• Study Completion Date: 2023-10-10

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.

Conditions

Pain Management; Sternotomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Liposomal bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Exparel

Intervention Type: DRUG

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

Bupivacaine

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

Group Type: ACTIVE_COMPARATOR

Bupivacaine

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Jared Staab, DO

Study Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jared Staab, DO

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Angie Ballew, DC, MS

Role: CONTACT

aballew@kumc.edu

9139457420

Facility Contacts

Abigail Houchin

Role: primary

ahouchin@kumc.edu

Other Identifiers

STUDY00140472

Identifier Type: -

Identifier Source: org_study_id