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 |
| Protocol serial number | N/A |
| Sponsor | James Cook University Hospital (UK) |
| Funder | James Cook University Hospital (UK) - Anaesthetic Department |
- 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
Scientific
Anaesthetic Department
Cheriton House
James Cook University Hospital
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
| Phone | +44 (0)1642 850850 ext 4600 |
|---|---|
| gerard.danjoux@stees.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled double blind trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Laevo-bupivacaine |
| Primary outcome measure(s) |
Mean systolic blood pressures over the first 24 hours postoperatively. |
| Key secondary outcome measure(s) |
1. Need for antihypertensive treatment |
| Completion date | 20/11/2006 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Anaesthetic Department
Middlesbrough
TS4 3BW
United Kingdom
TS4 3BW
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
