Liposomal Bupivacaine in Total Shoulder Arthroplasty
EXP-TSA
Liposomal Bupivacaine Versus Interscalene Nerve Block for Pain Control After Shoulder Arthroplasty: A Prospective Randomized Trial
1 other identifier
interventional
57
1 country
1
Brief Summary
This is a randomized, single blinded, standard of care controlled clinical trial. All adult patients over eighteen desiring shoulder arthroplasty will be eligible. The study compares pain control and opioid consumption in patients undergoing shoulder arthroplasty between patients receiving liposomal bupivacaine and those who underwent a preoperative inter-scalene nerve block.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 pain
Started Oct 2014
Typical duration for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 5, 2015
CompletedFirst Posted
Study publicly available on registry
October 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedResults Posted
Study results publicly available
October 13, 2016
CompletedOctober 13, 2016
August 1, 2016
1.6 years
October 5, 2015
June 8, 2016
August 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Levels
Patients recorded pain levels every four hours using Visual analog scales for four days post operatively. Average daily pain was calculated for each patient. Range of the visual analog scale was 0-10, where 0 indicated a lower amount of pain and 10 indicated higher amount of pain.
four days postoperatively
Secondary Outcomes (1)
Morphine Equivalents
four days postoperatively
Study Arms (2)
Liposomal bupivacaine
EXPERIMENTALPatients in this group received local infiltration of Liposomal bupivacaine before the end of surgery.
Inter-scalene nerve block
ACTIVE COMPARATORPatients in this group received preoperative ultrasound guided inter-scalene nerve blocks by senior anesthesiologist using ropivicaine.
Interventions
Local infiltration of liposomal bupivacaine
Pre-operative inter-scalene nerve block
Eligibility Criteria
You may not qualify if:
- Patients will be excluded if their medical history presents known allergies or intolerance to dexamethasone, opioid or bupivacaine, substantial alcohol or drug abuse, and pregnancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henry Ford Health System
Detroit, Michigan, 48202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Use of the VAS, which is a simple one-dimensional analog rating scale, to assess the patients subjective pain level. Patient compliance is a limitation, with maintenance of pain dairies decreasing as time from surgery progressed.
Results Point of Contact
- Title
- Dr. Kelechi Okoroha
- Organization
- Henry Ford Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sub-Investigator
Study Record Dates
First Submitted
October 5, 2015
First Posted
October 7, 2015
Study Start
October 1, 2014
Primary Completion
May 1, 2016
Study Completion
June 1, 2016
Last Updated
October 13, 2016
Results First Posted
October 13, 2016
Record last verified: 2016-08