Contact information
Type
Scientific
Contact name
Dr Jeremy Nightingale
ORCID ID
Contact details
Anaesthetic Department
Portsmouth Hospitals NHS Trust
Queen Alaxandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
+44 (0)1705 286279
captainsensible@soberton.swinternet.co.uk
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
SEO130
Study information
Scientific title
Acronym
Study hypothesis
The purpose of this investigation is to determine whether analgesia provided by Patient Controlled Epidural Analgesia (PCEA) is more effective than Continuous Epidural Infusion Analgesia (CEIA) in patients undergoing major abdominal surgery.
This knowledge would allow acute pain services to plan either to provide PCEA as a routine service, or to confine their services to continuous infusion epidural analgesia.
Ethics approval(s)
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Not specified
Study type
Not Specified
Patient information sheet
Condition
Symptoms and general pathology: Pain
Intervention
i. PCEA or ii. CEIA using Bupivacaine 0.125% with Fentanyl 4 µg/ml via a Graseby 9500 pump. Patients in both groups will receive a loading dose of bupivacaine 0.25% via the epidural catheter, which is then attached to the pump. For patients in the CEIA group (controls) the pump will be programmed to deliver a continuous infusion of 10 ml/hour but the patient demand button will be disabled although it will still make a 'click noise' when pressed. For those in the PCEA arm, the pump will be programmed to deliver a continual dose of 8 ml/hour and a bolus dose of 3 ml on activation of the patient demand button, with a lockout interval of 20 min.
Intervention type
Other
Primary outcome measure
a. Pain scores: This will be recorded using the hospital standard system which has been adopted by Wessex Acute Pain Forum as part of the minimum data set. It is a simple numerical scale of 0-3. In addition a standard 10 cm Vas marked at either extreme is used. Data will be collected hourly for the first 4 hours and 4 hourly thereafter. Patient will be scored at rest and on movement.
b. Patient's perception on control: In order to incorporate the notion of control we will utilise a standardised questionnaire to measure 'beliefs about controlling pain'
c. Patient's overall satisfaction of their pain control: at 72 hours and on discharge (between days 7-10), patients will be asked to record their overall impression of their pain control
d. Side effects: All patients will be assessed for incidence of sedation, nausea and vomiting, and respiratory depression. Pruritus and urinary retention will be noted and treated accordingly.
e. Analgesia usage: Consumption of epidural drugs and requirement for rescue analgesia will be recorded for all patients
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/10/2000
Overall study end date
30/09/2003
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Adult patients admitted to the Queen Alexandra Hospital for elective large bowel resection will be approached.
Participant type(s)
Patient
Age group
Not Specified
Sex
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Patients with contra-indication to epidural analgesia, poor co-ordination and hand arthritis.
Recruitment start date
01/10/2000
Recruitment end date
30/09/2003
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Anaesthetic Department
Portsmouth
PO6 3LY
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
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
NHS Executive South East (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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2007 | Yes | No |