Comparison of Sternal Wound Infiltration With Liposomal Bupivacaine v. Bupivacaine Hydrochloride
NCT ID: NCT03270514
Last Updated: 2021-09-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2018-11-15
2020-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Exparel Injectable Product
Liposomal Bupivacaine (Exparel) Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the liposomal bupivacaine (Exparel) group (\~30).
Exparel Injectable Product
Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
Bupivacaine Hydrochloride
Bupivacaine Injection administered approximately 20 cc per inch of sternotomy wound. Half of subjects enrolled will be randomized to the bupivacaine group (\~30).
Bupivacaine Hydrochloride
Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
Interventions
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Exparel Injectable Product
Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
Bupivacaine Hydrochloride
Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Surgery with the use of cardiopulmonary bypass
Exclusion Criteria
* Patient undergoing procedures under deep hypothermic circulatory arrest
* Patients with active infections such as infective endocarditis
* Emergency surgery
* Patients undergoing transplantations and ventricular assist device insertion
* Patients on any mechanical circulatory support preoperatively
* Patient's refusal
* End stage liver or renal disease
* Allergy to bupivacaine
* Patient who cannot understand the study procedure or refuse to participate
* Redo-sternotomy
* Participation in another study
* Patients with severe right or left ventricular dysfunction (EF\< 25%)
* Patients requiring chronic opioids for chronic pain condition
18 Years
ALL
No
Sponsors
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Pacira Pharmaceuticals, Inc
INDUSTRY
Kathirvel Subramaniam
OTHER
Responsible Party
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Kathirvel Subramaniam
Principal Investigator, Associate Professor
Principal Investigators
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Kathirvel Subramaniam, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Associate Professor and staff Anesthesiologist
Locations
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UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States
Countries
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References
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Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.
Beck DE, Margolin DA, Babin SF, Russo CT. Benefits of a Multimodal Regimen for Postsurgical Pain Management in Colorectal Surgery. Ochsner J. 2015 Winter;15(4):408-12.
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Okoroha KR, Lynch JR, Keller RA, Korona J, Amato C, Rill B, Kolowich PA, Muh SJ. Liposomal bupivacaine versus interscalene nerve block for pain control after shoulder arthroplasty: a prospective randomized trial. J Shoulder Elbow Surg. 2016 Nov;25(11):1742-1748. doi: 10.1016/j.jse.2016.05.007. Epub 2016 Jul 14.
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Balkhy HH, Arnsdorf S, Krienbring D, Urban J. Liposome Bupivacaine for Postsurgical Analgesia in Patients Undergoing Robotically Assisted Cardiac Surgery. Innovations (Phila). 2015 Nov-Dec;10(6):416-9. doi: 10.1097/IMI.0000000000000190.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PRO17060305
Identifier Type: -
Identifier Source: org_study_id
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