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OpenTrials
Completed

NCT Number: NCT02225054

The Effect of Dexmedetomidine on Brachial Plexus Block for Shoulder Surgery

The purpose of this study is to determine whether a small dose of Dexmedetomidine, when given either intravenously or as part of the interscalene nerve block solution, prolongs pain relief following shoulder surgery compared to local anesthetic solution alone.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

About this study

Unilateral shoulder surgical procedures, including acromioplasty, rotator cuff repair and Bankart procedure generally allow the patient to go home the same day. However, post-surgical pain is often severe and it is common to encounter a delay in discharge from the hospital due to difficulty in pain control.

Single shot interscalene block is used in ambulatory shoulder surgery for its advantages that included a significant reduction in acute pain and analgesic requirements, prolonged time to first analgesic request, decreased incidence of nausea, as well as earlier hospital discharge. Previous studies have attempted to prolong the duration of the analgesia of interscalene block by administering additional drugs to the local anesthetics but these studies have had varying degrees of success. Dexmedetomidine has recently been considered as a potentially useful drug in prolonging nerve block analgesia. Various modes of administration of Dexmedetomidine have demonstrated a consistent effect on the duration of analgesia. So far, the systemic infusion of Dex has been shown to prolong both neuraxial and peripheral nerve blocks. When combined with local anesthetics in intravenous regional anesthesia 9IVRA), Dex enhanced the duration of analgesia. Furthermore, data from animal studies strongly support the use of Dex as a safe potent adjunct to local anesthetics capable of prolonging the duration of analgesia of peripheral nerve blocks.

The use of Dexmedetomidine as an adjunct in interscalene block has not been studied yet. This trial will study the effects of adding Dexmedetomidine as an adjunct to local anesthetics in interscalene brachial plexus block.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • unilateral surgical shoulder procedures under general anesthetic
  • English speaking patients
  • ASA I-III patients
  • BMI <38 kg/m2

Exclusion criteria

  • proximal clavicular surgery
  • preexisting neurological deficits or peripheral neuropathy
  • known coronary heart disease, congestive heart failure, cardiomyopathies, or arrhythmias
  • known cerebrovascular disease
  • baseline heart rate <60 beats per minute or baseline systolic blood pressure <100 mm Hg
  • medications that reduce heart rate (as beta-blockers, calcium blockers) known liver dysfunction or existing diseases known to cause hepatic or renal impairment
  • severe bronchopulmonary disease
  • local infection
  • contra-indication to regional anesthesia (bleeding, coagulopathy)
  • chronic pain disorders
  • current use of over 30mg oxycodone or equivalent per day
  • contraindication to a component of multimodal analgesia
  • allergy to local anesthetics or dexmedetomidine
  • history of significant psychiatric conditions that may affect patient assessment
  • pregnancy
  • inability to provide consent

Treatment and study plan

Dexmedetomidine

Drug

0.5 u/kg Dexmedetomidine diluted in saline to 1 mL (single interscalene injection) Dexmedetomidine 0.5 u/kg as a single IV bolus over 30 minutes following GA induction

Other names: Precedex

Ropivacaine

Drug

15 ml 0.5%

Other names: Naropin

normal saline

Drug

1 mL 0.9%

Primary outcomes

  1. Duration of interscalene nerve block.

    Time frame: Duration of time is from the end of local anesthetic injection (interscalene block) to the onset of pain at the surgical site.

  2. Opioid consumption

    Time frame: Cumulative opioid consumption at 24 hours postoperatively

Secondary outcomes

  1. Opioid Consumption

    Time frame: Total use of opioids from the period of intra-operative to 2 weeks post-operative

    The total amount of opioid use starting from during surgery to 14 days following surgery. Opioid side effects, patient satisfaction with pain control and the time to discharge from hospital will all be assessed Any evidence of nerve block complications at 3 months, post-block administration , will also be assessed.

Sponsors and collaborators

Lead sponsor

Women's College Hospital

Other

Registry information

Official study title

The Analgesic Effect of Dexmedetomidine as an Adjunct to Local Anesthetics in Ultrasound-guided Interscalene Approach to Brachial Plexus Block for Shoulder Surgery: A Randomized Controlled Trial

Acronym: DEX

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Aug 25, 2014
Registry last updated
Nov 6, 2017

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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