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Trial record 3 of 29 for:    "Nerve Compression Syndrome" | "Anti-Inflammatory Agents"

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

Tracking Information
First Submitted Date  ICMJE January 24, 2016
First Posted Date  ICMJE January 28, 2016
Last Update Posted Date September 7, 2016
Study Start Date  ICMJE September 2016
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2016)
Time to first sensation of pain at the surgical site. [ Time Frame: 72 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02666443 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2016)
  • duration of motor blockade [ Time Frame: 72 hours ]
    time (in hours) to return of full pre-operative strength in the operative limb
  • morphine or morphine equivalent usage in the first 48 h postoperatively [ Time Frame: 48 hours ]
  • incidence of nausea and vomiting and pruritus in the first 48 h [ Time Frame: 48 hours ]
  • numerical rating scale (NRS) pain scores at 8 h, 24 h, 48 h, and post-operative day 7 [ Time Frame: 7 days ]
  • residual paraesthesias or motor blockade at 7 days. [ Time Frame: 7 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Low Dose Dexamethasone in Supraclavicular Blocks
Official Title  ICMJE Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study
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.

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Rheumatoid Arthritis
  • Osteoarthritis
  • Nerve Entrapment
  • Ligament Injury
Intervention  ICMJE
  • 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
  • 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
  • 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
Study Arms  ICMJE
  • Placebo Comparator: Control (C)
    Control intervention (no dexamethasone)
    Intervention: Drug: Control intervention (no dexamethasone)
  • Experimental: Peri-neural (N)
    Peri-neural Dexamethasone 1 mg
    Intervention: Drug: Peri-neural Dexamethasone 1 mg
  • Experimental: Intravenous
    Intravenous Dexamethasone 1 mg
    Intervention: Drug: Intravenous Dexamethasone 1 mg
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2016)
306
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2021
Estimated Primary Completion Date February 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
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
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02666443
Other Study ID Numbers  ICMJE REB13-1350
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party Dr. Nathan Brown, University of Calgary
Study Sponsor  ICMJE University of Calgary
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nathan JD Brown, BMSc, MD University of Calgary
PRS Account University of Calgary
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP