The Effect of Systemic or Perineural Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01495624|
Recruitment Status : Terminated (Accrual insufficient to complete study in a feasible time frame)
First Posted : December 20, 2011
Last Update Posted : January 27, 2016
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.
|Condition or disease||Intervention/treatment|
|Duration of Interscalene Block||Other: ropivacaine plus dexamethasone anesthetic Other: ropivacaine plus saline plus dexamethasone anesthetic|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Study Start Date :||December 2011|
|Primary Completion Date :||January 2016|
|Study Completion Date :||January 2016|
Placebo Comparator: Ropivacaine with perineural dexamethasone
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);
Other: ropivacaine plus dexamethasone anesthetic
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);
Active Comparator: Ropivacaine with systemic steroid
30 ml 0.5% ropivacaine for interscalene block mixed with 2 ml normal saline (perineural placebo) plus dexamethasone 8 mg (2 ml) administered systemically.
Other: ropivacaine plus saline plus dexamethasone anesthetic
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.
- duration of interscalene nerve block [ Time Frame: Day one ]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.
- increase in shoulder discomfort [ Time Frame: as reported in minutes after procedure, day one ]time to a noticeable increase in shoulder discomfort, maximum VRS with rest and movement, and total opioid consumption.
- maximum VRS (Verbal Response Score) with rest [ Time Frame: upon admission to PACU through post operative day 2, post operative day 14 ]time to a noticeable increase in shoulder discomfort, maximum VRS (Verbal Response Score) with rest and movement, and total opioid consumption.
- Verbal Response Score (VRS) with movement [ Time Frame: upon admission daily through post operative day 2, post operative day 14 ]time to a noticeable increase in shoulder discomfort, maximum VRS with rest and movement, and total opioid consumption.
- total opioid consumption [ Time Frame: daily through post operative day 2 ]time to a noticeable increase in shoulder discomfort, maximum VRS with rest and movement, and total opioid consumption.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01495624
|United States, Ohio|
|Cleveland Clinic Foundation|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Kenneth Cummings, MD||The Cleveland Clinic|