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Low Dose Dexamethasone in Supraclavicular Blocks

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ClinicalTrials.gov Identifier: NCT02666443
Recruitment Status : Recruiting
First Posted : January 28, 2016
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Nathan Brown, University of Calgary

Brief Summary:

Brachial plexus nerve blocks provide superior analgesia over opioids while avoiding unwanted side effects. Single shot blocks with local anesthetic alone usually do not last the duration of the acute post-surgical pain period. This has led to the exploration of multiple adjuvants to increase the duration of single shot blocks, the most promising adjuvant being dexamethasone.

Peri-neural administration is an off-label use of dexamethasone. While no adverse events have been reported in human clinical studies, logic would dictate that we minimize the dose needed to produce the desired effect. Most studies thus far have used peri-neural dexamethasone doses ranging from 4-10 mg. However, Albrecht et al. found no difference in block duration comparing 4 mg and 8 mg doses while Liu et al. reported equivalent block duration using doses of 1, 2 and 4 mg.

Recent studies have evaluated whether systemic and peri-neural administrations of dexamethasone are equivalent, which would in turn imply a site of action. Results have been mixed. Four studies concluded peri-neural and intravenous administration are equivalent at prolonging analgesia, though one study had methodological errors, including the administration of intravenous dexamethasone to all patients. All of these studies used dexamethasone doses of 8 to 10 mg. One study where a lower dose (4 mg) was used found that peri-neural administration prolonged block duration whereas intravenous did not.

With that, the rationale of our study is to determine if equivalent block-prolonging analgesia can be achieved using low dose (1 mg) dexamethasone given peri-neural or intravenous. Clinical experience at our centre has been that 1 mg dexamethasone added to 20 mL produces similar block duration to that reported in published studies using higher doses.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Osteoarthritis Nerve Entrapment Ligament Injury Drug: Control intervention (no dexamethasone) Drug: Peri-neural Dexamethasone 1 mg Drug: Intravenous Dexamethasone 1 mg Not Applicable

Detailed Description:

The investigators will evaluate the block-prolonging efficacy of dexamethasone 1 mg in supraclavicular blocks. The investigators will be answering essentially two questions. First, how long do supraclavicular blocks last when low dose dexamethasone is used as an adjunct. Only one study has looked at doses this low (Liu et al. 2015). Some methodological problems with this study include evaluation of shoulder surgery using supraclavicular blocks, which may or may not cover the posterior port site; use of the endpoint of "time to first analgesic", which may or may not indicate actual block duration; and low numbers powered to 80%, which may yield spurious results. To avoid these issues the investigators chose upper limb surgery, a type of block which will definitely cover the entire surgical site, and an endpoint of time to first pain at surgical site, regardless of whether analgesic is needed. The investigators are also powering to 95% and recruiting higher numbers of patients.

The second question evaluates the efficacy of 1 mg of intravenous dexamethasone. The study is powered to address this question, but in doing so is also powered adequately to address the first question. Studies to date have mixed results and methodological errors. No other studies have evaluated this dose of intravenous dexamethasone.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 306 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study
Study Start Date : September 2016
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2021


Arm Intervention/treatment
Placebo Comparator: Control (C)
Control intervention (no dexamethasone)
Drug: Control intervention (no dexamethasone)
Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL normal saline, and an intravenous solution of 50 mL normal saline.
Other Name: Control

Experimental: Peri-neural (N)
Peri-neural Dexamethasone 1 mg
Drug: Peri-neural Dexamethasone 1 mg
Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL dexamethasone 1% (1 mg dexamethasone), and an intravenous solution of 50 mL normal saline.
Other Name: Peri-neural

Experimental: Intravenous
Intravenous Dexamethasone 1 mg
Drug: Intravenous Dexamethasone 1 mg
Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL normal saline, and an intravenous solution of 49.9 mL normal saline with 0.1mL dexamethasone 1%
Other Name: IV




Primary Outcome Measures :
  1. Time to first sensation of pain at the surgical site. [ Time Frame: 72 hours ]

Secondary Outcome Measures :
  1. duration of motor blockade [ Time Frame: 72 hours ]
    time (in hours) to return of full pre-operative strength in the operative limb

  2. morphine or morphine equivalent usage in the first 48 h postoperatively [ Time Frame: 48 hours ]
  3. incidence of nausea and vomiting and pruritus in the first 48 h [ Time Frame: 48 hours ]
  4. numerical rating scale (NRS) pain scores at 8 h, 24 h, 48 h, and post-operative day 7 [ Time Frame: 7 days ]
  5. residual paraesthesias or motor blockade at 7 days. [ Time Frame: 7 days ]


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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:

  • Adult 18 - 80 years
  • BMI equal to or less than 35
  • Upper limb surgery
  • Normal pre-operative sensation in the operative limb

Exclusion Criteria:

  • Pre-operative opioid greater than 4 Tylenol #3 per day (or equivalent)
  • Pre-existing, fluctuating neurologic injury involving operative upper limb
  • Patient refusal or patient inability to provide consent
  • Suspected inability to comply with study procedures, including language difficulties or medical history and/or concomitant disease (skin infection at site of needle insertion) as judged by the investigator or attending anesthesiologist, reason for exclusion will be recorded.
  • Patient pregnancy
  • Patient BMI > 35
  • Patient allergy to any of the drugs used in the protocol
  • Surgical concern of postoperative neurological injury from surgical manipulation.
  • Brittle diabetics
  • Other contraindication to receiving a block (coagulopathy, significant respiratory risk, etc.)
  • Surgeon refusal (e.g. concerns about compartment syndrome); reason for exclusion will be recorded

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): NCT02666443


Contacts
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Contact: Nathan JD Brown, BMSc, MD 403-956-3883 nathan.brown@albertahealthservices.ca
Contact: Melissa T Jack, MD, PhD 403-956-3883 melissa.jack@albertahealthservices.ca

Locations
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Canada, Alberta
South Health Campus Recruiting
Calgary, Alberta, Canada, T3M 1M4
Contact: Nathan JD Brown, BMSc MD    403-956-3883    nathan.brown@albertahealthservices.ca   
Contact: Melissa T Jack, MD PhD FRCPC    403-956-3883    melissa.jack@albertahealthservices.ca   
Sub-Investigator: Shaylyn H Montgomery, MSc MD FRCPC         
Sub-Investigator: Mark A Kostash, MD FRCPC         
Sponsors and Collaborators
University of Calgary
Investigators
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Principal Investigator: Nathan JD Brown, BMSc, MD University of Calgary

Publications:
Beecroft CL, Coventry DM. Anaesthesia for shoulder surgery. Continuing Education in Anaesthesia, Critical Care & Pain 2008 ; 8: 193-98
Ultrasound for Regional Anesthesia, Supraclavicular Block. 2008; http://www.usra.ca/supneedle.php accessed September 22, 2015

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Responsible Party: Dr. Nathan Brown, Staff Anesthesiologist, Calgary Department of Anesthesia, University of Calgary
ClinicalTrials.gov Identifier: NCT02666443     History of Changes
Other Study ID Numbers: REB13-1350
First Posted: January 28, 2016    Key Record Dates
Last Update Posted: September 7, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: I am not sure what the entirety of a "yes" answer entails, or with whom the data would be shared. Hence, undecided.

Keywords provided by Dr. Nathan Brown, University of Calgary:
brachial plexus
supraclavicular
duration
dexamethasone
block

Additional relevant MeSH terms:
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Nerve Compression Syndromes
Osteoarthritis
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Dexamethasone
Dexamethasone acetate
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