Condition category
Surgery
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
17/04/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes