Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

• Sponsor: University of Kansas Medical Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04585867
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Management; Sternotomy	Drug: Exparel; Drug: Bupivacaine	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy
• Actual Study Start Date: Oct 11, 2017
• Anticipated Primary Completion Date: Oct 10, 2023
• Anticipated Study Completion Date: Oct 10, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Opioid consumption in morphine equivalents [0 hours post-surgery]

   Opioid consumption in morphine equivalents

2. Opioid consumption in morphine equivalents [12 hours post-surgery]

   Opioid consumption in morphine equivalents

3. Opioid consumption in morphine equivalents [24 hours post-surgery]

   Opioid consumption in morphine equivalents

4. Opioid consumption in morphine equivalents [36 hours post-surgery]

   Opioid consumption in morphine equivalents

5. Opioid consumption in morphine equivalents [48 hours post-surgery]

   Opioid consumption in morphine equivalents

6. Opioid consumption in morphine equivalents [60 hours post-surgery]

   Opioid consumption in morphine equivalents

7. Opioid consumption in morphine equivalents [72 hours post-surgery]

   Opioid consumption in morphine equivalents

Secondary Outcome Measures

1. 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

2. 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

3. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Kansas Medical Center	Kansas City	Kansas	United States	66160

Sponsors and Collaborators

• University of Kansas Medical Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jared Staab, DO, Study Principal Investigator, University of Kansas Medical Center
• ClinicalTrials.gov Identifier: NCT04585867
• Other Study ID Numbers: STUDY00140472
• First Posted: Oct 14, 2020
• Last Update Posted: Oct 14, 2020
• Last Verified: Oct 1, 2020

• 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
• Additional relevant MeSH terms: Bupivacaine

Study Results

No Results Posted as of Oct 14, 2020