About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients 18 years or older
Patients admitted to TGH for total shoulder replacement surgery
Subjects who have given written informed consent
Disqualifiers
Patients with allergic reactions to Exparel or Ropivacaine
Female patients who are pregnant
Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade (e.g., subjects with myasthenia gravis)
Trial design
Parallel
Treatments tested in this trial
Exparel
DrugSingle shot of the Bupivacaine Liposome, and then we follow up with patient in the recovery room with traditional common pain management. MME (milligram morphine equivalent) will be collected.
Ropivacaine
DrugContinuous infusion of Ropivacaine via catheter, and then we follow up with patient in the recovery room with traditional common pain management. MME (milligram morphine equivalent) will be collected.
Treatment groups
Trial outcomes
Primary outcomes
Duration of Surgery (in minutes)
Post-Operative VAS Scores (10 cm scale)
Intraoperative Narcotics Usage (in Milligrams Morphine Equivalent; MME)
Length of Post-Anesthesia Care Unit (PACU) stay (in minutes)
Secondary outcomes
Time spent Nerve Block Procedure (in minutes)
Cost of Adjuvant Therapy (in United States Dollar)
Locations
Sponsors and contacts
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University of South Florida
Lead sponsor
Pacira Pharmaceuticals, Inc
Collaborator
This trial is not recruiting at the moment. You can still explore other options: