Accrual insufficient to complete study in a feasible time frame
Sponsor study identifier
interventional
16
1 country
1
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)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, adding dexamethasone to the local anesthetic mixture may be unnecessary. Although no study has reported neurotoxicity from perineural dexamethasone and laboratory data appear to confirm the safety of this route, achieving similar results with more conventional administration would be desirable for two reasons. First, conventional intravenous dosing is convenient, useful for other reasons (for example, postoperative nausea prophylaxis), and well-studied. Second, equivalent (or not equivalent) results from systemic dosing would provide valuable information about the mechanism behind dexamethasone's effect on block duration.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2016
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
December 12, 2011
Actual (reported)December 20, 2011
Actual (reported)January 2016
Actual (reported)January 2016
Actual (reported)duration of interscalene nerve block
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.
Day one
increase in shoulder discomfort
as reported in minutes after procedure, day one
maximum VRS (Verbal Response Score) with rest
upon admission to PACU through post operative day 2, post operative day 14
Verbal Response Score (VRS) with movement
upon admission daily through post operative day 2, post operative day 14
total opioid consumption
daily through post operative day 2
30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic with 2 ml normal saline given intravenously (systemic placebo);
30 ml 0.5% ropivacaine for interscalene block mixed with 2 ml normal saline (perineural placebo) plus dexamethasone 8 mg (2 ml) administered systemically.
Subjects will receive interscalen block comprised of 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic with 2 ml normal saline given intravenously (systemic placebo);
Subjects will receive interscalen block with 30 ml 0.5% ropivacaine for interscalene block mixed with 2 ml normal saline (perineural placebo) plus dexamethasone 8 mg (2 ml) administered systemically.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
ropivacaine plus dexamethasone anesthetic
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordGrouped treatment entry
ropivacaine plus saline plus dexamethasone anesthetic
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordCleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Bei T, Liu J, Huang Q, Wu J, Zhao J. Perineural Versus Intravenous Dexamethasone for Brachial Plexus Block: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Pain Physician. 2021 Sep;24(6):E693-E707.
Kenneth Cummings, MD
The Cleveland Clinic
16 participants (actual enrollment reported by the registry).
First Submitted
December 12, 2011
First Posted
December 20, 2011
Study Start
December 2011
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
January 2016
Actual (reported)Study Completion
January 2016
Actual (reported)Last Updated
January 27, 2016
Record last verified: 2016-01
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Source: ClinicalTrials.gov.
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