| Source of record | UK Trials |
| ISRCTN | ISRCTN52716583 |
| Date ISRCTN assigned | 28/11/2005 |
| Local reference number(s) | N/A |
| Public title | The haemodynamic effect of superficial cervical plexus blockade in patients undergoing carotid endarterectomy under general anaesthesia |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Blood pressure lability |
| 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. |
| Design/methodology | Randomised controlled double blind trial |
| Research ethics review | Ethics approval received on the 22nd July 2004; amendment approved 27th May 2005 (ref: 04/Q1001/21). |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Patients at James Cook University Hospital undergoing carotid endartectomy |
| Participants - 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) |
| Patient information material |
|
| Anticipated start date | 20/11/2005 |
| Anticipated end date | 20/11/2006 |
| Status of trial | Completed |
| Target number of participants | 54 |
| Interventions | 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 |
| Primary outcome measure(s) | Mean systolic blood pressures over the first 24 hours postoperatively. |
| Secondary outcome measure(s) | 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. |
| Sources of funding | James Cook University Hospital (UK) - Anaesthetic Department |
| Sponsor name | James Cook University Hospital (UK) |
| Sponsor details | Cheriton House
Anaesthetic Department
Marton Road
Middlesbrough
United Kingdom
TS4 3BW |
| Sponsor telephone | +44 (0)1642 850850 ext 4600 |
| Sponsor email | drsarah.platt@virgin.net |
| Contact name | Dr Gerard Danjoux |
| Contact details | Anaesthetic Department
Cheriton House
James Cook University Hospital
Marton Road
Middlesbrough
United Kingdom
TS4 3BW |
| Contact telephone | +44 (0)1642 850850 ext 4600 |
| Contact email | gerard.danjoux@stees.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN52716583 |
| Date last extracted from ISRCTN register | 17/04/2008 |
