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Completed

NCT Number: NCT02412657

Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous dexamethasone increases the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot interscalene block with ropivacaine.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Pierre-Boucher, Longueuil, Quebec, Canada

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About this study

75 patients will be randomly assigned to three groups:

  • D10: dexamethasone 10 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
  • D4: dexamethasone 4 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
  • C: control: Normal saline 20cc I.V., immediately after inter scalene block. These patient will be recruited from 3 hospitals, with two surgeons performing the surgeries.

All patients will have their surgery under regional anesthesia only provided by the inter scalene plexus block, with ropivacaine 0.5% 20cc.

In the postoperative period, patients will be given analgesic medication on an as needed basis. They will be instructed to take the first analgesic medication once postoperative shoulder pain has reached >3/10. They will note the time and day at which this outcome occurs.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Elective shoulder arthroscopy under ropivacaine single-shot interscalene brachial plexus block anesthesia (rotator cuff repair and shoulder decompression)
  • ASA I-III
  • Age 18-80 years old

Exclusion criteria

  • Any contraindication to interscalene brachial plexus block anesthesia
  • Interscalene brachial plexus block failure
  • Known local anesthetics allergy
  • Dexamethasone allergy or intolerance
  • Any contraindication to acetaminophen
  • Any contraindication to morphine or hydromorphone
  • Brachial plexus neuropathies
  • Chronic pain syndrome other than shoulder pain
  • Routine use of opioid medication
  • Routine use of systemic corticosteroid
  • Pregnancy
  • Weight below 50 kilograms
  • Incapability to understand a numeric verbal pain scale
  • Incapability to consent
  • Patient refusal

Treatment and study plan

Dexamethasone

Drug

After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v.

Other names: decadron

normal saline

Drug

Primary outcomes

  1. Duration of Analgesia

    Time frame: 48 hours after surgery

    Defined as the time between the performance of the block and the first analgesic request

Secondary outcomes

  1. Pain Scores

    Time frame: every 6 hours during the first 48 hours after surgery

    On a 11-points Verbal Numeric Scale 0-10 (0= no pain, 10= worst conceivable pain)

  2. Residual Motor Block

    Time frame: 24 hours and 48 hours

    Scale of 0-2 (0:inability to move fingers, 1: fingers able to move, with diminished strength compared to non operated side, 2: No motor weakness of the fingers)

  3. Sleep Disturbance

    Time frame: 24 hours and 48 hours

    Sleep disturbance scale 0-10 (0: no sleep disturbance from pain, 10: worst conceivable sleep disruption from pain)

  4. Patients Overall Satisfaction

    Time frame: 48 hours

    categorical data (1: very satisfied, would recommend this analgesia protocol to others, 0: not satisfied, would not recommend this analgesia protocol to others

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Registry information

Official study title

Impact of Two Doses of Intravenous Dexamethasone on the Analgesic Duration of a Single-shot Interscalene Block With Ropivacaine for Shoulder Arthroscopy; a Prospective, Randomized, Placebo-controlled Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 9, 2015
Registry last updated
Sep 13, 2018

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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