ED95 bupivacaine and supraclavicular block
| ISRCTN | ISRCTN63230740 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63230740 |
| Secondary identifying numbers | 7925 |
- Submission date
- 29/04/2010
- Registration date
- 29/04/2010
- Last edited
- 25/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Phil Hopkins
Scientific
Scientific
Beckett Street
Leeds
LS9 7TF
United Kingdom
Study information
| Study design | Non-randomised interventional trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Not Specified |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | What is the ED95 dose for bupivacaine for supraclavicular brachial plexus block using ultrasound? |
| Study objectives | To determine the ED95 dose for 0.5% bupivacaine for supraclavicular brachial plexus block using ultrasound. |
| Ethics approval(s) | Leeds (East) Research Ethics Committee approved on the 2nd November 2009 (ref: 09/H1306/98). Amendment approved on the 22nd February 2010. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 05/10/2009 |
| Completion date | 04/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 40 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 05/10/2009 |
| Date of final enrolment | 04/10/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Beckett Street
Leeds
LS9 7TF
United Kingdom
LS9 7TF
United Kingdom
Sponsor information
University of Leeds (UK)
University/education
University/education
Academic Department of Rehabilition Medicine
Woodhouse Lane
Leeds
LS2 9JT
England
United Kingdom
| neville.young@leedsth.nhs.uk | |
| Website | http://www.leeds.ac.uk/ |
"ROR" |
https://ror.org/024mrxd33 |
Funders
Funder type
Government
National Institute for Academic Anaesthesia (UK)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- NIAA
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2013 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
