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Completed

NCT Number: NCT02322242

The Effects of Dexamethasone on Low Dose Interscalene Brachial Plexus Block

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Lack of patient consent
  • Allergy to dexamethasone or ropivacaine
  • BMI > 35 kg/m2
  • Contraindications to low dose dexamethasone including peptic ulcer disease, systemic infection, glaucoma, active varicella/herpetic infections, diabetes mellitus
  • 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
  • Pregnant or nursing females
  • Chronic opioid use defined as > 30mg oral morphine or equivalent per day
  • Unable to take acetaminophen or celecoxib

Treatment and study plan

Systemic dexamethasone

Drug

Intravenous infusion of dexamethasone (4mg)

Other names: Dexamethasone Sodium Phosphate Injection

Perineural dexamethasone

Drug

Perinerual administration of dexamethasone (4mg)

Other names: Dexamethasone Sodium Phosphate Injection

Primary outcomes

  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 outcomes

  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, scale 0-100, higher number is better

  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. Numeric Rating Scale for Pain (NRS 0-10)

    Time frame: 7 days postoperative

    Recorded at 12 hours, 24 hours, and 7 days 0 is no pain, 10 is the worst pain imaginable. Lower number is better.

  6. Postoperative Serum Blood Glucose

    Time frame: 1 hour postoperative

    Measured 1 hour after arrival to the post-operative recovery room

  7. Number of Participants With Nerve Damage From Interscalene Block

    Time frame: 7 Days postoperative

    Defined as persistent paresthesia, and sensory/motor block at 7 days

  8. Infection

    Time frame: 7 Days postoperative

    Number of participants with localized infection at nerve block site

  9. Number of Participants With Postoperative Nausea and/or Vomiting

    Time frame: 7 days postoperative

    Number of participants with postoperative nausea and/or vomiting assessed at 12 hours, 24, hours, and 7 days postoperatively

Sponsors and collaborators

Lead sponsor

Dr. Stephen Choi

Other

Collaborators

  • The Physicians' Services Incorporated Foundation

Registry information

Official study title

Comparison of the Effects of Perineural Versus Systemic Dexamethasone on Low Dose Interscalene Brachial Plexus Block: A Randomized Control Trial

Acronym: ISB-Dex

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Dec 23, 2014
Registry last updated
Jul 15, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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