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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: Clinical Trial NA study, sponsored by The Cleveland Clinic.

NCT01495624 is a NA study that was terminated before completion, run by The Cleveland Clinic. The registered enrollment target is 16 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

The clinical duration of the interscalene nerve block, which will be measured by time from onset of sensory block until first administration of analgesic medication or requirement for initiation of the perineural catheter infusion.

Interventions

  • OTHER ropivacaine plus dexamethasone anesthetic
  • OTHER ropivacaine plus saline plus dexamethasone anesthetic

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2011-12
Est. Completion 2016-01
Phase NA
The Cleveland Clinic

688 total trials

Why NCT01495624 stopped before completion

NCT01495624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which ropivacaine plus dexamethasone anesthetic is the first listed.

NCT01495624 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01495624's enrollment target sits among peer trials

16 1871st of 2000 higher than 120 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT01495624, the US trial registry maintained by the National Library of Medicine. NCT01495624 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.