Condition category
Surgery
Date applied
29/04/2010
Date assigned
29/04/2010
Last edited
25/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Phil Hopkins

ORCID ID

Contact details

Beckett Street
Leeds
LS9 7TF
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7925

Study information

Scientific title

What is the ED95 dose for bupivacaine for supraclavicular brachial plexus block using ultrasound?

Acronym

Study hypothesis

To determine the ED95 dose for 0.5% bupivacaine for supraclavicular brachial plexus block using ultrasound.

Ethics approval

Leeds (East) Research Ethics Committee approved on the 2nd November 2009 (ref: 09/H1306/98). Amendment approved on the 22nd February 2010.

Study design

Non-randomised interventional trial

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Generic Health Relevance and Cross Cutting Themes; Subtopic: Generic Health Relevance (all Subtopics); Disease: Anaesthetics

Intervention

Primary outcome is the success or failure of the supraclavicular block. This will be assessed by testing the patient's ability to detect cold sensation by application of a cold alcohol swab to the skin. This will be measured by asking the patient to score the cold sensation from 0 - 10. Any score higher than 0 will be deemed an unsuccessful block. This assessment will be carried out at 15 minute intervals for upto 45 minutes after the block has been performed. There will be no follow up after this.

Intervention type

Procedure/Surgery

Phase

Phase IV

Drug names

Primary outcome measures

Ability to detect cold sensation by application of cold alcohol swab to the skin at the sensory dermatomes of the median, ulnar, radial and musculocutaneous nerves in the upper limb, measured 45 minutes after performing the supraclavicular block.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

05/10/2009

Overall trial end date

04/10/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. American Society of Anaesthesiologists (ASA) 1 - 3 patients
2. Aged greater than 18 years, either sex
3. Routine hand, forearm or upper limb surgery

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 40

Participant exclusion criteria

1. ASA greater than 3
2. Aged less than 18 years
3. Allergy to bupivacaine
4. Unable to give written informed consent
5. Body Mass Index greater than 35 kg/m^2
6. Pregnant women

Recruitment start date

05/10/2009

Recruitment end date

04/10/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Beckett Street
Leeds
LS9 7TF
United Kingdom

Sponsor information

Organisation

University of Leeds (UK)

Sponsor details

Academic Department of Rehabilition Medicine
Woodhouse Lane
Leeds
LS2 9JT
United Kingdom
neville.young@leedsth.nhs.uk

Sponsor type

University/education

Website

http://www.leeds.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Academic Anaesthesia (UK)

Alternative name(s)

NIAA

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23648519

Publication citations

  1. Results

    Kant A, Gupta PK, Zohar S, Chevret S, Hopkins PM, Application of the continual reassessment method to dose-finding studies in regional anesthesia: an estimate of the ED95 dose for 0.5% bupivacaine for ultrasound-guided supraclavicular block., Anesthesiology, 2013, 119, 1, 29-35, doi: 10.1097/ALN.0b013e31829764cf.

Additional files

Editorial Notes