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

NCT ID: NCT01495624

Last Updated: 2016-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2016-01-31

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.

Conditions

Duration of Interscalene Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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);

Group Type: PLACEBO_COMPARATOR

ropivacaine plus dexamethasone anesthetic

Intervention Type: OTHER

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);

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.

Group Type: ACTIVE_COMPARATOR

ropivacaine plus saline plus dexamethasone anesthetic

Intervention Type: OTHER

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.

Interventions

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);

Intervention Type: 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.

Intervention Type: OTHER

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Kenneth Cummings III, MD, MS

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kenneth Cummings, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34554686 (View on PubMed)

Other Identifiers

11-1048

Identifier Type: -

Identifier Source: org_study_id