Clinical Trial

Exparel for Total Shoulder Pain

Study acronym: ETSP
Not Yet Recruiting Phase 2/3
View on ClinicalTrials.gov →
Record status
This record was last updated July 16, 2019 (before its estimated March 1, 2020 completion). Its status may not reflect the trial's current state.
Summary
Total shoulder surgery (arthroplasty) is a widely successful method of treating shoulder arthritis. Although the goal of the procedure is pain relief, post-operative pain is unavoidable. Pain is a common side effect that many patients undergo while in the clinical setting and is a vital factor in influencing the length of hospital stay, narcotic usage, as well as overall patient satisfaction. Post-operative pain management typically involves elevated usage of narcotics, which is a concern among clinicians and researchers alike. To combat this issue, research is examining intraoperative procedures as a means of reducing post-operative pain scores. Research has discovered the advantages of utilizing local anesthetic techniques as opposed to just general anesthesia. Local anesthetic blocks function by preventing the generation of nerve impulses by increasing the action-potential threshold, thereby inhibiting movement. Previous studies have demonstrated the success of local anesthetic interscalene blocks across several medical procedures. For instance, Exparel (liposomal bupivacaine) has been effective in reducing post-operative pain scores in tonsillectomy and shoulder arthroplasty. Another local anesthetic, Ropivacaine, has been found to be potent when utilized via a cervical paravertebral catheter among thoracic procedures. Our study will compare Exparel (bupivacaine liposome) with Ropivacaine continuous infusion for post-operative pain scores in total shoulder surgery patients. Additionally, we will collect data on complications, length of stay, and other variables.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2018-11-08; most recent amendment 2022-05-23.
Status change: Not Yet Recruiting → Completed 2021-11-04
Trial Details
NCT Number NCT03739021
Lead Sponsor University of South Florida
Collaborators: Pacira Pharmaceuticals, Inc
Conditions Chronic Shoulder Pain
Enrollment 60 participants
Start Date 2019-11
Primary Completion 2020-03-01 (estimated)
Study Completion 2020-11-15 (estimated)
Updated on ClinicalTrials.gov 2019-07-16