Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0054174157
Study information
Scientific title
Are the sympathetic sensorimotor changes induced by thoracic epidural anaesthesia such that mobilization is possible?
Acronym
Study hypothesis
To determine if the degree of haemodynamic and sensorimotor changes caused by a thoracic epidural infusion can allow early mobilization in patients having thoracotomies and if an opiate only epidural facilitates early mobilization. To determine if patients having thoracic epidural analgesia for thoracotomies can be mobilized early in the post operative period. The effect of the thoracic epidural on blood pressure, sensation, strength, co ordination, vibration sense and proprioception (the ability to sense the position of a limb in space). Scientific Basis: Patients having thoracotomies usually receive thoracic epidural analgesia. A local anaesthetic and opiate drug are usually used in combination to provide pain relief. The presence of a thoracic epidural especially the local anaesthetic component has been thought to produce weakness of the limbs and sensory changes that prevent patients from being mobilized. However mobilization of these patients has many benefits in terms of their respiratory function and overall recovery. There has been no previous work to show that early mobilization is possible in the presence of a functioning epidural in our group of patients. We hope to demonstrate that using an opiate only epidural will make early mobilization a possibility.
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: Thoracotomy
Intervention
A total of 80 patients who have been listed for elective thoracotomy for whom epidural analgesia has been agreed will be invited to participate in the study on the day before their operation. The epidural will be sited before the operation and following surgery the functioning of the epidural will be confirmed. A combination of local anaesthetic and opiate (morphine like drug) will be administered via the epidural and the patient sent to the ward to receive their routine postoperative care.
They will be visited at 24, 48 and 72 hours during the postoperative period. At the 24 hour visit the epidural solution will be changed, so that the patient receives one of the previously coded syringes. The investigators will have been blinded as to the contents of the syringes. The patients will either receive a combination of local anaesthetic and opiate or an opiate alone. A series of measurements will be obtained during these visits, which are designed to elicit if the patient is able to mobilize safely. These will include measurement of blood pressure in the sitting and standing position, assessment of strength in the legs and arms. Different modalities of sensation will be tested including coordination and proprioception (the ability to sense the position of a limb in space). Pain will be assessed using the visual analogue scale. The subjects will then be asked if they experience any symptoms like headache, nausea, dizziness or blurring of vision. If they are found to fit the criteria then patients will be invited to mobilize with the help of assistants. Patients will only be asked to mobilize at the 48 hour and 72 hours visits.
Date: 08/08/2005 Reference: 05/Q1501/123 Online Form
NHS REC Application Form − Version 4.1 4 AB/38774/1
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
Demographic data will be recorded: age, height, weight, hand dominance, ASA classification, preoperative medication, surgical procedure, blood loss and level of surgical incision. Primary outcome: The ability to walk with a thoracic epidural.
Secondary outcome measures
The effect of thoracic epidural blockade on each of the following measurements-systolic, diastolic, mean blood pressure, heart rate change when moving from the sitting to the upright position, leg motor power, dominant side hand grip strength, proprioception, vibration sense, and co ordination.
Overall trial start date
01/09/2005
Overall trial end date
30/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
All adult patients having elective thoracotomy under general anaesthesia with epidural analgesia for post operative pain relief at the Cardiothoracic Centre, Liverpool.
The statistical calculations were done based on a similar study looking at epidural analgesia in labor in an ambulatory patient (Anesth Analg 1993;77:919-24). This paper suggests a failure to ambulate in 10% of the patients in the fentanyl group. A difference of 25% between this and the fentanyl/bupivacaine group would be significant clinically. With an alpha error of 5% and a power of 89% then n=80, which is 40 patients in each group.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
80
Participant exclusion criteria
1. Patients unable to mobilize preoperatively due to pre existing neurological, cardiorespiratory or locomotor disease
2. Those with known autonomic nervous system dysfunction, those on beta blockers, those with moderate severe angina (Canadian Cardiovascular Society Class 3 or 4), those with diabetes, those with known allergy to bupivacaine/ fentanyl
3. Routine contraindications to epidural catheter placement will apply
Recruitment start date
01/09/2005
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
The Cardiothoracic Centre
Liverpool
L14 3PE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
The Cardiothoracic Centre Liverpool NHS Trust (UK), NHS R&D Support Funding
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