Intravenous and Perineural Dexamethasone for Ultrasound-Guided Axillary Blocks

March 21, 2017 updated by: De QH Tran, Montreal General Hospital

A Randomized Comparison Between Intravenous and Perineural Dexamethasone for Ultrasound-Guided Axillary Blocks

Dexamethasone prolong the duration of brachial plexus blocks, but the optimal route, intravenous (IV) or perineural (PN), remains controversial.

This Multi-centric trial compare IV and PN dexamethasone for ultrasound-guided axillary brachial plexus blocks (AXBs). Research hypothesis is that PN modality will outlast its IV counterpart. Since analgesic duration and sensory duration can be influenced by intake of pain medications and surgical trauma to small cutaneous nerves, the investigators will select motor block duration as the main outcome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After Ethics Committee of the McGill University Health Centre, a total of 150 patients undergoing upper extremity surgery (below the elbow) will be recruited.

All AXBs will be supervised by one of the coauthors and conducted preoperatively in an induction room. This area will have full access to an oxygen source, resuscitative equipment and drugs.

All patients will have fasted for at least eight hours. An IV cannula will be placed prior the block and will be monitored and given oxygen at 2-4 L/min through nasal cannulas.

Light sedation will be provided for patient comfort if needed.Patients will be placed supine with the shoulder abducted and the elbow flexed. The AXB will have a puncture site superior to the axillary artery. After skin disinfection and draping, a skin wheal will be raised with 3 mL of lidocaine 1.5%.

In both groups, 30 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL will be used. A 22-gauge, 5 cm block will be advanced under direct US vision toward the musculocutaneous nerve. Six mL of LA will be deposited in this location. The needle will then be directed posterior to the artery, at 6 o'clock position and twenty-four mL of LA will be deposited to obtain a spread around the artery.

Patients will be randomized to receive 8 mg of IV or PN dexamethasone. In the IV group, patients will receive 0.8 mL of dexamethasone (10 mg/mL) intravenously and 0.8 mL of normal saline will be added to the injectate through the block needle. In the PN group, patients will receive 0.8 mL of normal saline intravenously and 0.8 mL of dexamethasone (10 mg/mL) will be added to the injectate through the block needle.

A research assistant will prepare the IV and PN injectates. The operator, patient and investigator assessing the block will be blinded to group allocation.

If placement of the needle tip in the desired location is unsuccessful after 15 minutes, the procedure will be stopped and the patient excluded from the study. Brachial plexus blockade will be carried out using an alternative method. If the alternative method fails as well, the patient will be given general anesthesia and intravenous narcotics will be used for postoperative analgesia

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 2
  • Phase 3

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

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital, McGill University
  • Thailand
      • Bangkok, Thailand, 50200
        • Ramathibodi Hospital, Mahidol University,
      • Chiang Mai, Thailand, 10400
        • Maharaj Nakorn Chiang Mai Hospital

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Below Elbow surgery
  • Age between 18 and 80 years
  • American Society of Anesthesiologists classification 1-3
  • Body mass index between 18 and 35 kg/m2

Exclusion Criteria:

  • Adults who are unable to give their own consent
  • Pre-existing neuropathy (assessed by history and physical examination)
  • Coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or partial prothrombin time ≥ 50)
  • Renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
  • Hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
  • Allergy to local anesthetics (LAs)
  • Pregnancy
  • Prior surgery in the axillary region
  • Chronic pain syndromes requiring opioid intake at home

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Intravenous dexamethasone 8 mg
patients receiving intravenous 8 mg of dexamethasone in parallel to ultrasound guided axillary nerve block with a standardized local anesthetic solution
Other: intravenous 8 mg dexamethasone and perineural 0.8 ml of saline solution
Active Comparator: Perineural dexamethasone 8 mg
patient receiving perineural 8 mg of dexamethasone in a mixture with a standardized local anesthetic solution for ultrasound guided axillary block
Other: intravenous 0,8 ml of saline solution and perineural 8 mg of dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor block duration
Time Frame: 24 hours
Duration of the motor block (defined as the temporal interval between the end of LA injection through the block needle and the return of movement to the hand and fingers). Patient is contacted at the next day of the surgery and asked about the time when the motor block started to disappear.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of the sensory block
Time Frame: 24 hours
defined as the temporal interval between the end of LA injection through the block needle and the return of sensation to the hand and fingers
24 hours
Analgesia duration
Time Frame: 24 hours
defined as the temporal interval between the end of LA injection through the block needle and the appearance of pain at the surgical site
24 hours
Onset time
Time Frame: 30 minutes

Time required to reach a minimal score of 14 points of a total of 16. Sensory blockade will be graded according to a 3-point scale using a cold test: 0 = no block, 1 = analgesia (patient can feel touch, not cold), 2 = anesthesia (patient cannot fee touch). The cold test will be applied with light touch to avoid confusion with deep pressure sensation.

Motor blockade will also be graded on a 3-point scale: 0 = no block, 1 = paresis, 2 = paralysis (19). Motor blockade of the musculocutaneous, radial, median and ulnar nerves will be evaluated by elbow flexion (musculocutaneous), thumb abduction (radial), thumb opposition (median) and thumb adduction (ulnar).
30 minutes
Success rate
Time Frame: 30-60 minutes
Ability to proceed with surgery without the need for intravenous narcotics, general anesthesia, rescue blocks or LA infiltration by the surgeon. Just propofol based sedation (25-80 μg/kg/min) will be permitted if necessary, keeping always response to verbal stimulus.
30-60 minutes

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic data
Time Frame: 30 minutes
sex, age, weight, height, type of surgery
30 minutes
Side effects
Time Frame: 30-60 minutes
vascular puncture, hematoma at the site of puncture, toxic effects of LA
30-60 minutes
Persistent deficit
Time Frame: 7 days
All patients will be contacted after 7 days by a blinded observer asking about persistent sensory or motor deficit in relation with the blocked nerves.
7 days

Collaborators and Investigators

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

Sponsor

Montreal General Hospital

Investigators

  • Principal Investigator: De QH Tran, MD, FRCPC, Associate Professor

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

January 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

December 10, 2015

First Submitted That Met QC Criteria

December 11, 2015

First Posted (Estimate)

December 14, 2015

Study Record Updates

Last Update Posted (Actual)

March 22, 2017

Last Update Submitted That Met QC Criteria

March 21, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MontrealGH

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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