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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 is a Phase 4 study that was terminated before completion, run by The Christ Hospital. The registered enrollment target is 22 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03219983
The ClinicalTrials.gov registry entry for NCT03219983 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Christ Hospital, which has 13 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ropivacaine is the first listed.
NCT03219983 reports 0 study locations.
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.
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