Effectiveness of Patient Controlled Epidural Analgesia (PCEA) compared with Continuous Epidural Infusion Analgesia (CEIA) in patients undergoing elective Large Bowel Resection
| ISRCTN | ISRCTN33488737 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN33488737 |
| Secondary identifying numbers | SEO130 |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 04/03/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Jeremy Nightingale
Scientific
Scientific
Anaesthetic Department
Portsmouth Hospitals NHS Trust
Queen Alaxandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom
| Phone | +44 (0)1705 286279 |
|---|---|
| captainsensible@soberton.swinternet.co.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | 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 |
| Health condition(s) or problem(s) studied | 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 |
| Completion date | 30/09/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | Adult patients admitted to the Queen Alexandra Hospital for elective large bowel resection will be approached. |
| Key exclusion criteria | Patients with contra-indication to epidural analgesia, poor co-ordination and hand arthritis. |
| Date of first enrolment | 01/10/2000 |
| Date of final enrolment | 30/09/2003 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Anaesthetic Department
Portsmouth
PO6 3LY
United Kingdom
PO6 3LY
United Kingdom
Sponsor information
NHS R&D Regional Programme Register - Department of Health (UK)
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.doh.gov.uk |
Funders
Funder type
Government
NHS Executive South East (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/03/2007 | Yes | No |
