Low Dose Dexamethasone in Supraclavicular Blocks

September 2, 2016 updated by: Dr. Nathan Brown, University of Calgary

Low Dose Dexamethasone as an Adjuvant to Supraclavicular Brachial Plexus Blocks: A Prospective Randomized, Double Blinded, Control Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

306

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to first sensation of pain at the surgical site.
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of motor blockade
Time Frame: 72 hours
time (in hours) to return of full pre-operative strength in the operative limb
72 hours
morphine or morphine equivalent usage in the first 48 h postoperatively
Time Frame: 48 hours
48 hours
incidence of nausea and vomiting and pruritus in the first 48 h
Time Frame: 48 hours
48 hours
numerical rating scale (NRS) pain scores at 8 h, 24 h, 48 h, and post-operative day 7
Time Frame: 7 days
7 days
residual paraesthesias or motor blockade at 7 days.
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Principal Investigator: Nathan JD Brown, BMSc, MD, University of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (ANTICIPATED)

February 1, 2020

Study Completion (ANTICIPATED)

February 1, 2021

Study Registration Dates

First Submitted

January 24, 2016

First Submitted That Met QC Criteria

January 24, 2016

First Posted (ESTIMATE)

January 28, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 2, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB13-1350

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

I am not sure what the entirety of a "yes" answer entails, or with whom the data would be shared. Hence, undecided.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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