The Effect of Systemic or Perineural Dexamethasone on the Duration of Interscalene Nerve Blocks With Ropivacaine

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by The Cleveland Clinic
Sponsor:
Information provided by (Responsible Party):
Kenneth Cummings III, MD, MS, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT01495624
First received: December 12, 2011
Last updated: September 11, 2012
Last verified: September 2012
  Purpose

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 Intervention
Duration of Interscalene Block
Other: ropivacaine plus dexamethasone anesthetic
Other: ropivacaine plus saline plus dexamethasone anesthetic

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care

Resource links provided by NLM:


Further study details as provided by The Cleveland Clinic:

Primary Outcome Measures:
  • duration of interscalene nerve block [ Time Frame: Day one ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • increase in shoulder discomfort [ Time Frame: as reported in minutes after procedure, day one ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    time to a noticeable increase in shoulder discomfort, maximum VRS with rest and movement, and total opioid consumption.


Estimated Enrollment: 438
Study Start Date: December 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495624

Contacts
Contact: Kenneth Cummings, MD 216-444-1016 cummink2@ccf.org

Locations
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Kenneth Cummings, MD    216-444-1016    cummink2@ccf.org   
Contact: Gretchen Upton    216-444-3289    uptong@ccf.org   
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Kenneth Cummings, MD The Cleveland Clinic
  More Information

No publications provided

Responsible Party: Kenneth Cummings III, MD, MS, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01495624     History of Changes
Other Study ID Numbers: 11-1048
Study First Received: December 12, 2011
Last Updated: September 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Cleveland Clinic:
rotator cuff repair
capsular shift
shoulder arthroplasty
subacromial decompression
18 and 75 years

Additional relevant MeSH terms:
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Ropivacaine
BB 1101
Anesthetics
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Central Nervous System Depressants
Sensory System Agents

ClinicalTrials.gov processed this record on October 19, 2014