Condition category
Signs and Symptoms
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
04/03/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

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 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial 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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2000

Overall trial end date

30/09/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Adult patients admitted to the Queen Alexandra Hospital for elective large bowel resection will be approached.

Participant type

Patient

Age group

Not Specified

Gender

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

United Kingdom

Trial 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

http://www.doh.gov.uk

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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17283006

Publication citations

  1. Results

    Nightingale JJ, Knight MV, Higgins B, Dean T, Randomized, double-blind comparison of patient-controlled epidural infusion vs nurse-administered epidural infusion for postoperative analgesia in patients undergoing colonic resection., Br J Anaesth, 2007, 98, 3, 380-384, doi: 10.1093/bja/ael367.

Additional files

Editorial Notes