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NCT01495624 · ClinicalTrials.gov registry record · NA
The Effect of Systemic or Perineural Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine
A NA study, sponsored by The Cleveland Clinic.
- Terminated
- Registry status
- NA
- Development phase
- 16
- Enrollment target
NCT01495624 is a NA study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 16 participants.
The verdict
NCT01495624, a NA study, was terminated before completion, sponsored by The Cleveland Clinic.
- TERMINATED
- Registry status
- NA
- Development phase
- 16 participants
- Enrollment target
Study Summary
Patients undergoing rotator cuff repair or subacromial decompression at the investigators institution are frequently hospitalized overnight due to inadequate pain relief after resolution of interscalene brachial plexus blocks. For ropivacaine 0.5%, the investigators usual local anesthetic, previous studies report an analgesic duration of 11.1 ± 5 hours without epinephrine and approximately 12 hours with epinephrine. Consequently, a method of prolonging analgesia from a brachial plexus block without the extra equipment and logistical difficulties of indwelling catheters would benefit both patients and caregivers. A potential approach is use of adjuvant drugs that prolong block duration when added to the local anesthetic. In addition to the usual adjuvant anesthetic drugs, investigators have begun to evaluate glucocorticoids as adjuvants for regional anesthesia. Known for their anti-inflammatory, analgesic, immunosuppressive, and antiemetic properties, these corticosteroids exert their effects by inhibition of phospholipase A2 as well as changes in cell function induced by glucocorticoid receptor activation. Although associated with significant toxicity when administered in large doses for long periods, emerging literature suggests that a single perioperative dose of glucocorticoid is safe. Several studies, including a recent trial at the investigators institution, have demonstrated the efficacy of dexamethasone in prolonging regional anesthetics. Available data thus suggest that combining glucocorticoids with local anesthetics prolongs block duration. However, systemic glucocorticoids have also been shown to reduce postoperative pain. This raises the question whether the beneficial effects of adding glucocorticoid to a regional anesthetic is solely due to local effect or is mediated at least in part by systemic action. Previous trials, however, have not addressed this important issue. If this beneficial effect of analgesic duration is mediated by systemic action, ad
Interventions
- OTHER ropivacaine plus dexamethasone anesthetic
- OTHER ropivacaine plus saline plus dexamethasone anesthetic
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2011-12 |
| Est. Completion | 2016-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01495624
The ClinicalTrials.gov registry entry for NCT01495624 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ropivacaine plus dexamethasone anesthetic is the first listed.
NCT01495624 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01495624 about?
NCT01495624 is a clinical study titled "The Effect of Systemic or Perineural Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine". Patients undergoing rotator cuff repair or subacromial decompression at the investigators institution are frequently hospitalized overnight due to inadequate pain relief after resolution of interscalene brachial plexus blocks. For ropivacaine 0.5%, the investigators usual local anesthetic, previous ...
What is the current status of trial NCT01495624?
This trial is currently terminated. It is a NA study. The enrollment target is 16 participants. The study started on 2011-12. Estimated completion is 2016-01.
What interventions are being tested in trial NCT01495624?
The interventions under investigation include: ropivacaine plus dexamethasone anesthetic (OTHER), ropivacaine plus saline plus dexamethasone anesthetic (OTHER).
Who is sponsoring clinical trial NCT01495624?
This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.
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