Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

Pain Management Clinical Trial

Official title:

Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04585867
• Other study ID #: STUDY00140472
• Status: Recruiting
• Phase: Phase 1
• Start date: October 11, 2017
• Est. completion date: October 10, 2023

Study information

• Verified date: October 2020
• Source: University of Kansas Medical Center
• Contact: Angie Ballew, DC, MS
• Phone: 9139457420
• Email: aballew[@]kumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 10, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain Management
• Sternotomy

Intervention

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
• 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

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	0 hours post-surgery
Primary	Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	12 hours post-surgery
Primary	Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	24 hours post-surgery
Primary	Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	36 hours post-surgery
Primary	Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	48 hours post-surgery
Primary	Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	60 hours post-surgery
Primary	Opioid consumption in morphine equivalents	Opioid consumption in morphine equivalents	72 hours post-surgery
Secondary	Time to extubation in minutes will be retrieved via the electronic medical record	Time to extubation in minutes will be retrieved via the electronic medical record	30 days post operative
Secondary	Presence of sternal wound infection	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	4-6 weeks postoperative visit
Secondary	Postoperative delirium as assessed by Confusion Assessment Method (CAM)-ICU	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	30 days post operative