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Exparel for Total Shoulder Pain

NCT03739021 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2019-07-16

No results posted yet for this study

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.

Conditions

  • Chronic Shoulder Pain

Interventions

DRUG

Exparel

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.

DRUG

Ropivacaine

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.

Sponsors & Collaborators

  • Pacira Pharmaceuticals, Inc

    collaborator INDUSTRY

  • University of South Florida

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-30
Primary Completion
2020-03-01
Completion
2020-11-15
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03739021 on ClinicalTrials.gov