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NCT03219983 · ClinicalTrials.gov registry record · Phase 4
Pain Management After Total Shoulder Arthroplasty
A Phase 4 study, sponsored by The Christ Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 22
- Enrollment target
NCT03219983: Clinical Trial Phase 4 study, sponsored by The Christ Hospital.
NCT03219983 is a Phase 4 study that was terminated before completion, run by The Christ Hospital. The registered enrollment target is 22 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03219983, a Phase 4 study, was terminated before completion, sponsored by The Christ Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 22 participants
- Enrollment target
Study Summary
The purpose of the study is to determine if pain management after total shoulder arthroplasty is more efficacious with ultrasound guided, continuous Interscalene block or with local tissue infiltration with liposomal bupivacaine. Traditionally, general anesthesia followed by narcotics has been the primary management of pain control. However, regional anesthesia in the form of an interscalene block (ISB), a perineural local anesthetic infusion, is commonly used and may more effectively control pain during and after shoulder arthroplasty, with fewer side effects than narcotics. Intraoperative benefits include better control of blood pressure and reduced need for general anesthesia and narcotics. Depending on the type of block (single shot vs. continuous) and the type of local anesthetic administered, pain relief may persist for 12-96 hours postoperatively. However, not all patients are candidates for peripheral nerve blocks. Pre-existing pulmonary disease, previous neck surgery, cervical arthritis, neurologic disorders and obesity may preclude ISB placement. As well, interscalene blocks are not completely benign procedures. Systemic complications include clinically significant intraoperative hypotension, pneumothorax, vascular injury, cardiac arrest, respiratory failure, seizure and death. Phrenic nerve paralysis is common, although transient. Peripheral nerve injuries related to mechanical injury, medication neurotoxicity, compression or ischemia are infrequent but may be devastating. The experience and number of blocks performed by the anesthesiologist in addition to adjunctive tools, such as ultrasound and/or nerve stimulators, impacts the success of the procedure. Continuous indwelling interscalene blocks (CISB) may provide substantial and longer pain relief, precluding the need for perioperative narcotics. Earlier discharge post procedure and better early range of motion are other purported benefits. However, premature catheter failure, catheter breakage, infe
Primary Outcome
The Numeric Pain Rating Scale(NPRS) is an 11 point scale with 0 being no pain and 10 being extreme pain. Patients select a value that is most in line with the intensity of pain that they have experienced.
Interventions
- DRUG Ropivacaine
- DRUG liposomal bupivacaine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2016-11 |
| Est. Completion | 2017-09 |
| Phase | Phase 4 |
Why NCT03219983 stopped before completion
NCT03219983 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which Ropivacaine is the first listed.
NCT03219983 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03219983 about?
NCT03219983 is a clinical study titled "Pain Management After Total Shoulder Arthroplasty". The purpose of the study is to determine if pain management after total shoulder arthroplasty is more efficacious with ultrasound guided, continuous Interscalene block or with local tissue infiltration with liposomal bupivacaine. Traditionally, general anesthesia followed by narcotics has been the ...
What is the current status of trial NCT03219983?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 22 participants. The study started on 2016-11. Estimated completion is 2017-09.
What interventions are being tested in trial NCT03219983?
The interventions under investigation include: Ropivacaine (DRUG), liposomal bupivacaine (DRUG).
Who is sponsoring clinical trial NCT03219983?
This trial is sponsored by The Christ Hospital, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03219983's enrollment target sits among peer trials
22 1731st of 2000 higher than 259 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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