Contact information
Type
Scientific
Contact name
Dr Gerard Danjoux
ORCID ID
Contact details
Anaesthetic Department
Cheriton House
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
+44 (0)1642 850850 ext 4600
gerard.danjoux@stees.nhs.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Carotid endarterectomy is performed in patients with severe stenosis (narrowing) of the carotid arteries. The operation improves blood supply to the brain and reduces the risk of stroke in selected patients. In the early post operative period following carotid endarterectomy patients commonly develop blood pressure lability. It is our observation that severe hypertension has decreased whilst hypotension requiring treatment has increased in our patient group over the past 2 years. Two changes in our practise may be contributing to this - first the majority of patients are now beta blocked, secondly our patients are now commonly given a superficial cervical plexus block. We aim to establish the influence of superficial cervical plexus blockade on post operative blood pressure control in these patients.
Our null hypothesis is that there is no clinically significant difference in the mean blood pressures in the first 24 hours following carotid endarterectomy in patients who have been given a superficial cervical plexus block and those who have not.
Ethics approval(s)
Ethics approval received on the 22nd July 2004; amendment approved 27th May 2005 (ref: 04/Q1001/21).
Study design
Randomised controlled double blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
Blood pressure lability
Intervention
Patients will receive a superfical cervical plexus block with either 2 mg/kg of laevo-bupivacaine or a placebo block with the equivalent volume of saline
Intervention type
Drug
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
Laevo-bupivacaine
Primary outcome measure
Mean systolic blood pressures over the first 24 hours postoperatively.
Secondary outcome measures
1. Need for antihypertensive treatment
2. Need for pressor treatment
3. Cumulative dose of any vasoactive medication
4. Mean pain scores
5. Cumulative opiate requirements
Any cardiovascular, cerebrovascular or other major morbidity or mortality occuring during the time period and any complication potentially related to the superficial cervical plexus block will also be recorded.
Overall study start date
20/11/2005
Overall study end date
20/11/2006
Reason abandoned (if study stopped)
Objectives no longer viable
Eligibility
Participant inclusion criteria
Patients at James Cook University Hospital undergoing carotid endartectomy
Participant type(s)
Patient
Age group
Adult
Sex
Both
Target number of participants
54
Participant exclusion criteria
Patients will be excluded if they:
1. Do not wish to take part
2. Are unfit for a general anaesthetic
3. Have a contraindication to either beta blockers or to being given a local anaesthetic block (e.g. local anaesthetic allergy and bleeding tendency)
Recruitment start date
20/11/2005
Recruitment end date
20/11/2006
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Anaesthetic Department
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
James Cook University Hospital (UK)
Sponsor details
Cheriton House
Anaesthetic Department
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom
+44 (0)1642 850850 ext 4600
drsarah.platt@virgin.net
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Hospital/treatment centre
Funder name
James Cook University Hospital (UK) - Anaesthetic Department
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|