Clinical trial NCT01495624: The Effect of Systemic or Perineural Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Duration of Interscalene Block
Keywords: rotator cuff repair
capsular shift
shoulder arthroplasty
subacromial decompression
18 and 75 years
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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, 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.


Eligibility criteria: Inclusion Criteria:

Patients undergoing shoulder procedures such as

* Rotator cuff repair
* Capsular shift
* Shoulder arthroplasty
* Subacromial decompression

  • Exclusion Criteria:
  * Contraindications to interscalene block
* Coagulopathy
* Infection at the needle insertion site
* Moderate to severe chronic obstructive pulmonary disease (COPD)
* Contralateral pneumothorax or diaphragmatic paralysis

  * Pregnancy
  * Preexisting neuropathy involving the surgical limb
  * Systemic glucocorticoid treatment (for at least one week) within six months of surgery
  * Routine opioid use (greater than 30 mg oxycodone per day or equivalent)

Primary outcomes:
measure: duration of interscalene nerve block
timeFrame: Day one
Secondary outcomes:
measure: increase in shoulder discomfort
timeFrame: as reported in minutes after procedure, day one
measure: maximum VRS (Verbal Response Score) with rest
timeFrame: upon admission to PACU through post operative day 2, post operative day 14
measure: Verbal Response Score (VRS) with movement
timeFrame: upon admission daily through post operative day 2, post operative day 14
measure: total opioid consumption
timeFrame: daily through post operative day 2
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kenneth Cummings, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.