ED95 Regional Anaesthesia

• Research type

  Research Study

• Full title

  ED95 doses of commonly used local anaesthetic agents for ultrasound guided brachial plexus blocks

• IRAS ID

  22187

• Contact name

  Philip Hopkins

• Sponsor organisation

  Leeds Teaching Hospitals Trust

• Eudract number

  2010-018466-22

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Local anaesthetics are highly toxic drugs. They can cause toxicity by an absolute overdose, accidental injection in a blood vessel or slow absorption from the area of injection. The risk of toxicity when performing regional anaesthesia can be reduced significantly by injecting the optimal amount of local anaesthetic at the correct site under direct vision using ultrasound. Ultrasound is now widely available in UK anaesthetic departments, but there is still no good evidence available on the optimal dose of the local anaesthetics. We aim to find out ED95 dose (this dose is effective in 19 out of 20 patients)of commonly used local anaesthetics for brachial plexus block. Brachial plexus block is used for anaesthesia and pain relief for shoulder, arm and hand surgery. Interscalene approach is used for shoulder operations while supraclavicular and axillary approaches are used for upper arm, forearm and hand surgery. This research trial will guide the anaesthetists to the starting optimal dose for these procedures. Ultrasound has been shown to reduce drug requirements for other blocks. Reducing the dose administered to a patient whilst maintaining efficacy will minimise risk of toxicity and enhance patient safety. We aim to recruit a total of 200 adult patients of either sex, to answer the research question based on the continual reassessment method. Patients will be recruited according to well-defined criteria. They will be fully informed about the study and have the choice of not participating or opting out at any time during the study. It is not going to affect the kind of treatment they receive. The experts in the field will perform this study with full safety precautions at Leeds Teaching Hospitals, Leeds. We are expecting to complete this trial within 30 months.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  10/H1307/104

• Date of REC Opinion

  22 Sep 2010

• REC opinion

  Further Information Favourable Opinion