Pain Management, Sternotomy
Conditions
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.
Interventions
DRUGExparel
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
DRUGBupivacaine
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
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption in morphine equivalents | 0 hours post-surgery | Opioid consumption in morphine equivalents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
United States
Contacts
Primary ContactAngie Ballew, DC, MS
Outcome results
None listed