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
Protocol serial number	SEO130
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South East (UK)

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

Anaesthetic Department
Portsmouth Hospitals NHS Trust
Queen Alaxandra Hospital
Southwick Hill Road
Cosham
Portsmouth
PO6 3LY
United Kingdom

Phone	+44 (0)1705 286279
Email	captainsensible@soberton.swinternet.co.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
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

United Kingdom
England

Study participating centre

Anaesthetic Department

Portsmouth
PO6 3LY
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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2007		Yes	No