Exparel for Total Shoulder Pain

Trial statusNot yet recruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of South Florida

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Exparel

    Drug

    Single 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

    Drug

    Continuous 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

60 Participants
are divided into 2 treatment groups
Group A: Group 1 (30 participants)Experimental treatment 1 intervention
Group B: Group 2 (30 participants)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Duration of Surgery (in minutes)

Time frame
Intraoperative
2

Post-Operative VAS Scores (10 cm scale)

Time frame
1 hour after surgery
3

Intraoperative Narcotics Usage (in Milligrams Morphine Equivalent; MME)

Time frame
Intraoperative
4

Length of Post-Anesthesia Care Unit (PACU) stay (in minutes)

Time frame
through study completion, 8 months-1 year (on average)

Secondary outcomes

1

Time spent Nerve Block Procedure (in minutes)

Time frame
Intraoperative
2

Cost of Adjuvant Therapy (in United States Dollar)

Time frame
through study completion, 8 months-1 year (on average)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of South Florida

Lead sponsor

Pacira Pharmaceuticals, Inc

Collaborator

This trial is not recruiting at the moment. You can still explore other options: