Condition category
Signs and Symptoms
Date applied
02/11/2005
Date assigned
28/11/2005
Last edited
26/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

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

Trial setting

Hospitals

Trial 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

Phase

Not Specified

Drug names

Laevo-bupivacaine

Primary outcome measures

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 trial start date

20/11/2005

Overall trial end date

20/11/2006

Reason abandoned

Objectives no longer viable

Eligibility

Participant inclusion criteria

Patients at James Cook University Hospital undergoing carotid endartectomy

Participant type

Patient

Age group

Adult

Gender

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

United Kingdom

Trial 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
United Kingdom
+44 (0)1642 850850 ext 4600
drsarah.platt@virgin.net

Sponsor type

Hospital/treatment centre

Website

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes