Effectiveness of Patient Controlled Epidural Analgesia (PCEA) compared with Continuous Epidural Infusion Analgesia (CEIA) in patients undergoing elective Large Bowel Resection

• Register: ISRCTN
• Last refreshed on: 13 January 2015
• Main ID: ISRCTN33488737
• Date of registration: 23/01/2004
• Prospective Registration: No
• Primary sponsor: NHS R&D Regional Programme Register - Department of Health (UK)
• Public title: Effectiveness of Patient Controlled Epidural Analgesia (PCEA) compared with Continuous Epidural Infusion Analgesia (CEIA) in patients undergoing elective Large Bowel Resection
• Date of first enrolment: 01/10/2000
• Target sample size: 0
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN33488737
• Study type: Interventional
• Study design: Randomised controlled trial (Not Specified)

Countries of recruitment

United Kingdom

Contacts

• Name: Jeremy Nightingale

Key inclusion & exclusion criteria

Inclusion criteria: Adult patients admitted to the Queen Alexandra Hospital for elective large bowel resection will be approached.
Exclusion criteria: Patients with contra-indication to epidural analgesia, poor co-ordination and hand arthritis.

Age minimum:
Age maximum:
Gender: Not Specified

Health Condition(s) or Problem(s) studied

Symptoms and general pathology: Pain
Signs and Symptoms
Pain

Intervention(s)

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.

Primary Outcome(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

Secondary Outcome(s)

Not provided at time of registration

Secondary ID(s)

SEO130

Source(s) of Monetary Support

NHS Executive South East (UK)