Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

Sponsors

Lead Sponsor: University of Kansas Medical Center

Source 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.

Overall Status Recruiting
Start Date October 11, 2017
Completion Date October 10, 2023
Primary Completion Date October 10, 2023
Phase Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Opioid consumption in morphine equivalents 0 hours post-surgery
Opioid consumption in morphine equivalents 12 hours post-surgery
Opioid consumption in morphine equivalents 24 hours post-surgery
Opioid consumption in morphine equivalents 36 hours post-surgery
Opioid consumption in morphine equivalents 48 hours post-surgery
Opioid consumption in morphine equivalents 60 hours post-surgery
Opioid consumption in morphine equivalents 72 hours post-surgery
Secondary Outcome
Measure Time Frame
Time to extubation in minutes will be retrieved via the electronic medical record 30 days post operative
Presence of sternal wound infection 4-6 weeks postoperative visit
Postoperative delirium as assessed by Confusion Assessment Method (CAM)-ICU 30 days post operative
Enrollment 80
Condition
Intervention

Intervention Type: Drug

Intervention Name: Exparel

Description: 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

Arm Group Label: Liposomal bupivacaine

Intervention Type: Drug

Intervention Name: Bupivacaine

Description: 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

Arm Group Label: Bupivacaine

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Jared Staab, DO Principal Investigator University of Kansas Medical Center
Overall Contact

Last Name: Angie Ballew, DC, MS

Phone: 9139457420

Email: [email protected]

Location
Facility: Status: Contact: University of Kansas Medical Center Abigail Houchin [email protected]
Location Countries

United States

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Kansas Medical Center

Investigator Full Name: Jared Staab, DO

Investigator Title: Study Principal Investigator

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Liposomal bupivacaine

Type: Active Comparator

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

Label: Bupivacaine

Type: Active Comparator

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

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Investigator)

Source: ClinicalTrials.gov