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Clinical Trial NCT03739021 (ETSP) for Chronic Shoulder Pain is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Exparel for Total Shoulder Pain (ETSP) Phase 2, Phase 3 60

Not yet recruiting
Clinical Trial NCT03739021 (ETSP) is designed to study Treatment for Chronic Shoulder Pain. This Phase 2 Phase 3 interventional study is not yet recruiting. Enrollment is planned to begin on 1 November 2019 until the study accrues 60 participants. Led by University of South Florida, this study is expected to complete by 15 November 2020. The latest data from ClinicalTrials.gov was last updated on 16 July 2019.
Brief 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 mana...Show More
Detailed Description
Procedure Description:

The investigators commonly use these blocks for patients requiring total shoulder replacement: the patient is usually sedated with propofol. The patient is positioned in the lateral decubitus, or sitting position for this block. After the skin preparation and draping, the fingers of the non-operative hand separate the trapezius and levator scapulae muscle and a 25 gauge needle is used to anest...

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Official Title

Analgesic Requirements for Post-operative Pain Control in Total Shoulder Replacement Patients: Comparison of Interscalene Single Shot Exparel (Bupivacaine Liposome) Injections to Cervical Paravertebral Catheter With Ropivacaine (0.2% Continuous Infusion)

Conditions
Chronic Shoulder Pain
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • ETSP
  • 37089
NCT ID Number
NCT03739021
Start Date (Actual)
2019-11
Last Update Posted
2019-07-16
Completion Date (Estimated)
2020-11-15
Enrollment (Estimated)
60
Study Type
Interventional
PHASE
Phase 2
Phase 3
Status
Not yet recruiting
Keywords
replacement
shoulder
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalGroup 1 (30 participants)
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.
ExperimentalGroup 2 (30 participants)
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.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Duration of Surgery (in minutes)
Intraoperative
Post-Operative VAS Scores (10 cm scale)
1 hour after surgery
Intraoperative Narcotics Usage (in Milligrams Morphine Equivalent; MME)
Intraoperative
Length of Post-Anesthesia Care Unit (PACU) stay (in minutes)
through study completion, 8 months-1 year (on average)
Post-Operative Narcotics Usage during PACU Stay (in Milligrams Morphine Equivalent; MME)
through study completion, 8 months-1 year (on average)
Post-Operative Narcotics Usage during first 72 hours after PACU discharge (Milligrams in Morphine Equivalents
First 72 hours after PACU discharge
Length of Hospital Stay (in hours)
through study completion, 8 months-1 year (on average)
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Time spent Nerve Block Procedure (in minutes)
Intraoperative
Cost of Adjuvant Therapy (in United States Dollar)
through study completion, 8 months-1 year (on average)
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • Patients 18 years or older
  • Patients admitted to TGH for total shoulder replacement surgery
  • Subjects who have given written informed consent

  • 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)
University of South Florida logoUniversity of South Florida101 active studies to explore
Pacira Pharmaceuticals, Inc logoPacira Pharmaceuticals, Inc
Study Central Contact
Contact: Enrico M Camporesi, MD, 8136009094, [email protected]
Contact: Maha Balouch, BA, 8138444071, [email protected]
No location data.