The haemodynamic effect of superficial cervical plexus blockade in patients undergoing carotid endarterectomy under general anaesthesia

ISRCTN	ISRCTN52716583
DOI	https://doi.org/10.1186/ISRCTN52716583
Secondary identifying numbers	N/A

Submission date: 02/11/2005
Registration date: 28/11/2005
Last edited: 26/05/2011

Recruitment status: Stopped
Overall study status: Stopped
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Gerard Danjoux
Scientific

Anaesthetic Department
Cheriton House
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom

Phone	+44 (0)1642 850850 ext 4600
Email	gerard.danjoux@stees.nhs.uk

Study information

Study design	Randomised controlled double blind trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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).
Health condition(s) or problem(s) studied	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
Completion date	20/11/2006
Reason abandoned (if study stopped)	Objectives no longer viable

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	54
Key inclusion criteria	Patients at James Cook University Hospital undergoing carotid endartectomy
Key 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)
Date of first enrolment	20/11/2005
Date of final enrolment	20/11/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Anaesthetic Department

Middlesbrough
TS4 3BW
United Kingdom

Sponsor information

James Cook University Hospital (UK)
Hospital/treatment centre

Cheriton House
Anaesthetic Department
Marton Road
Middlesbrough
TS4 3BW
England
United Kingdom

Phone	+44 (0)1642 850850 ext 4600
Email	drsarah.platt@virgin.net
"ROR"	https://ror.org/02vqh3346

Funders

Funder type

Hospital/treatment centre

James Cook University Hospital (UK) - Anaesthetic Department

No information available

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