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The Effects of Dexamethasone on Low Dose Interscalene Brachial Plexus Block (ISB-Dex)

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ClinicalTrials.gov Identifier: NCT02322242
Recruitment Status : Active, not recruiting
First Posted : December 23, 2014
Last Update Posted : September 13, 2018
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by (Responsible Party):
Dr. Stephen Choi, Sunnybrook Health Sciences Centre

Brief Summary:

A standard interscalene nerve block is performed with long acting local anesthetic (bupivacaine or ropivacaine in concentrations varying from 0.25% to 0.75%). The purpose of this study is to investigate the effect of the addition of perineural dexamethasone (4mg) to a standard ropivacaine solution (0.5%) on analgesic duration of low dose interscalene block compared to ropivacaine alone for interscalene block with systemic dexamethasone.

Ropivacaine is not an intervention as a local anesthetic is pre-requisite to performing a nerve block.


Condition or disease Intervention/treatment Phase
Shoulder Surgery Nerve Block Drug: Systemic Dexamethasone Drug: Perineural dexamethasone Phase 4

Detailed Description:
Interscalene brachial plexus block (ISB) is regarded as the standard of care for analgesia after shoulder surgery providing superior analgesia and reducing opioid consumption. Shoulder surgery, previously requiring inpatient admission for pain control, is now commonly performed on an ambulatory basis facilitated by ISB analgesia. The effects of single injection ISB dissipate after several hours unmasking the moderate to severe pain of the surgical insult and require strong opioid analgesia. Efforts to prolong ISB duration by increasing local anaesthetic (LA) dose are limited by their pharmacodynamics and narrow therapeutic window. To address some of these issues faced with prolonging ISB analgesia the addition of perineural adjuvants to local anesthetic (eg. clonidine, dexmedetomidine), have been investigated in an attempt to prolong peripheral nerve block duration with limited success. However, the corticosteroid dexamethasone, has been added to local anesthetic solutions for ISB and has demonstrated promise in preliminary studies. Perineural dexamethasone (8-10mg) in conjunction with local anesthetic prolongs the duration of ISB with an effect sizes ranging from 40% to 75% (absolute effect ~ 6 to 10 hours). Dexamethasone, however, is only approved for intramuscular or intravenous administration and therefore perineural use is currently off-label. There are several reasons that warrant a new randomized trial. Chiefly, all of the previous trials do not reflect modern regional anesthetic practice. These trials utilized peripheral nerve stimulation (PNS) and local anesthetic volumes of 30 to 40 ml. Modern ultrasound guided ISB (US-ISB) allows for more accurate, targeted deposition of local anesthetic with volumes ranging from 5 to 10 ml with no difference in block efficacy or duration compared to larger volumes (≥20ml). An ideal solution would be a local anesthetic with adjuvant mixture that allowed administration of lower volumes but with prolonged analgesic duration. The use of low dose local anesthetic with dexamethasone could be one such solution. A trial that demonstrates enhanced block quality and duration associated with perineural dexamethasone added to low dose local anesthetic may allow us to achieve both prolonged duration of effect and reduced side effects due to unwanted local anesthetic spread. This would create further significant benefits for patients and further promote the use of low dose local anesthetic techniques to anesthesiologists who do not currently use this technique.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of the Effects of Perineural Versus Systemic Dexamethasone on Low Dose Interscalene Brachial Plexus Block: A Randomized Control Trial
Actual Study Start Date : January 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Perineural Dexamethasone
ISB performed with local anesthetic (ropivacaine 0.5%) and perinerual dexamethasone (4mg)
Drug: Perineural dexamethasone
Perinerual administration of dexamethasone (4mg)
Other Name: Dexamethasone Sodium Phosphate Injection

Systemic Dexamethasone
ISB with local anesthetic alone (ropivacaine 0.5%) alone and intravenous dexamethasone (4mg)
Drug: Systemic Dexamethasone
Intravenous infusion of dexamethasone (4mg)
Other Name: Dexamethasone Sodium Phosphate Injection




Primary Outcome Measures :
  1. Duration of sensory block [ Time Frame: 1 day postoperative ]
    Defined as time from completion of block procedure to NRS for pain > 0 (in hours)


Secondary Outcome Measures :
  1. Time to first opioid consumption [ Time Frame: 1 day postoperative ]
    Defined as time from completion of block procedure to first consumption of opioid analgesic (in hours)

  2. Duration of motor block [ Time Frame: 1 day postoperative ]
    Defined as time from completion of block procedure to return to baseline motor function (in hours)

  3. Post-operative oxygen saturation on room air [ Time Frame: 1 hour postoperative ]
    Pulse oximetry (in %) measured 1 hour after arrival in post-operative recovery room

  4. Opioid consumption [ Time Frame: 7 days postoperative ]
    Opioid consumption (in oral morphine equivalents) will be recorded at 12 hours, 24 hours, and 7 days

  5. NRS for pain [ Time Frame: 7 days postoperative ]
    Recorded at 12 hours, 24 hours, and 7 days

  6. Postoperative serum blood glucose [ Time Frame: 1 hour postoperative ]
    Measured 1 hour after arrival to the post-operative recovery room

  7. Nerve damage form interscalene block [ Time Frame: 7 Days postoperative ]
    Nerve damage defined as persistent paresthesia, and sensory/motor block at 7 days

  8. Infection [ Time Frame: 7 Days postoperative ]
    Localized infection at nerve block site

  9. Postoperative nausea and/or vomitting [ Time Frame: 7 days postoperative ]
    Assessed at 12 hours, 24, hours, and 7 days postoperatively



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients undergoing arthroscopic shoulder surgery at Sunnybrook Health Sciences Centre, Toronto Western Hospital and Women's College Hospital.
  2. ASA functional status class I to III
  3. Age 18 to 80 years
  4. BMI ≤ 35 kg/m2

Exclusion Criteria:

  1. Lack of patient consent
  2. Allergy to dexamethasone or ropivacaine
  3. BMI > 35 kg/m2
  4. Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
  5. Contraindications to ISB including severe Chronic Obstructive Pulmonary Disease (Forced expiratory volume < 40% predicted), coagulopathy, pre-existing neurologic deficit in ipsilateral upper extremity, localized infection
  6. Pregnant or nursing females
  7. Chronic opioid use defined as > 30mg oral morphine or equivalent per day
  8. Unable to take acetaminophen or celecoxib

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02322242


Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Dr. Stephen Choi
The Physicians' Services Incorporated Foundation
Investigators
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Principal Investigator: Stephen Choi, MD,FRCPC,MSc SunnybrookHealth Sciences Centre

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Responsible Party: Dr. Stephen Choi, Assistant Professor and Staff Anesthetist, Department of Anesthesia, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT02322242     History of Changes
Other Study ID Numbers: 437-2013
First Posted: December 23, 2014    Key Record Dates
Last Update Posted: September 13, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Product Manufactured in and Exported from the U.S.: No

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