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Exparel for Total Shoulder Pain

Study acronym: ETSP
StatusNot Yet Recruiting
PhasePhase 2/3
Started
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.

Record History

  1. Notable Primary completion date: Aug 1, 2019 to Mar 1, 2020
    • Start date: May 2019 to Nov 2019
    • Study completion date: Sep 15, 2019 to Nov 15, 2020
    v4
  2. Notable Start date: Jan 25, 2019 to May 2019v3
  3. Notable Start date: Nov 1, 2018 to Jan 25, 2019
    • Primary completion date: Apr 1, 2019 to Aug 1, 2019
    • Study completion date: Apr 15, 2019 to Sep 15, 2019
    v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03739021
Lead Sponsor University of South Florida
Collaborators: Pacira Pharmaceuticals, Inc
Conditions
(from sponsor)
Chronic Shoulder Pain
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov