Contact information
Type
Scientific
Primary contact
Dr Gerry Danjoux
ORCID ID
Contact details
South Tees Hospital Trust
The James Cook University Hospital
Anaesthetics Department
Cheriton House
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
-
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0227149022
Study information
Scientific title
In patients undergoing carotid endarterectomy under general anaesthesia, does superficial cervical plexus blockade with the local anaesthetic bupivicaine affect post-operative blood pressure control?
Acronym
Study hypothesis
In the early post-operative period following carotid endarterectomy, patients commonly develop blood pressure liability. It is our observation that over the last 2 years the incidence of severe hypertension requiring treatment appears to have decreased whilst the incidence of hypotension appears to be increasing. There are two main changes to our practice that may be contributing to this observation: Firstly, the vast majority of our patients are now beta-blocked as this has been shown to improve outcome in patients undergoing vascular surgery. Secondly, our patients are now commonly given a superficial cervical plexus block in addition to a general anaesthetic as part of a multi-modal approach to post-operative analgesia. We would like to look at the influence of superficial cervical plexus blockade on post-operative blood pressure control in these patients.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Surgery: Carotid endarterectomy
Intervention
All patients undergoing carotid endarterectomy will receive a standardised general anaesthetic.
The patients in the study will be randomised to the treatment group who will receive a superficial cervical plexus block, or to a control group receiving no block.
This block will be performed in the anaesthetic room following induction of anaesthesia by the responsible anaesthetist using a standard block technique. Following surgery the patients will be monitored in recovery in the usual manner until stable before being transferred to the high dependency unit for the first 24 hours following surgery. Any pain will be treated with intravenous opiates or simple analgesics as appropriate. Blood pressure persistently greater than 160mmHg will be treated with labetolol or GTN. Hypotension persistently below 100mgHg will be treated with a fluid challenge and phenylephrine, according to the current HDU guidelines.
Intervention type
Drug
Phase
Not Applicable
Drug names
Bupivicaine
Primary outcome measures
Mean systolic blood pressure over the first 24 hours following surgery.
Secondary outcome measures
Secondary outcomes will include the need for vasopressor or antihypertensive medication, cumulative opiate requirements, and mean pain scores in recovery and HDU.
Any major cardiovascular or cerebrovascular morbidity or mortality in the first 24 hours, and any side effects potentially related to the block will be recorded.
Overall trial start date
01/09/2004
Overall trial end date
30/09/2007
Reason abandoned
Eligibility
Participant inclusion criteria
The patients will be selected from all patients presenting for carotid endarterectomy. The vast majority of these patients are now seen in the vascular preadmission clinic by a consultant anaesthetist. This clinic will provide the opportunity to discuss the project with the patients. They would then be able to consider at home prior to admission whether or not to participate. Consent where relevant would then be taken at the time of admission. Approximately 100 patients undergo this operation annually in the trust. We need to recruit at least 54 patients and we would hope to achieve this over 1 year.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
54
Participant exclusion criteria
Patients will be excluded if they have a contraindication to a block, such as coagulopathy, thrombocytopenia, treatment with clopidogrel or multiple anti-platelet agents within one week of surgery. Other exclusions will be patient refusal and known local anaesthetic allergy. In order to account for the potential influence of beta-blockade, only patients on perioperative beta blockade will be studied. Patients will therefore be excluded if they have a contraindication to beta-blockade.
1. Patients will be excluded if they do not wish to take part in this trial
2. Contra-indication to beta blockage therapy
3. Increase risk of bleeding (ie patients with low platelet counts , coagulopathy associated with liver dysfunction, treatment with multiple antiplatelet agents or treatment with clopidogrel in the 7 days prior to surgery)
4. Patients with known allergy to local anaesthetics
Recruitment start date
01/09/2004
Recruitment end date
30/09/2007
Locations
Countries of recruitment
United Kingdom
Trial participating centre
South Tees Hospital Trust
Middlesbrough
TS4 3BW
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
South Tees Hospitals NHS Trust (UK)
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
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary