Condition category
Signs and Symptoms
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
28/08/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Goldstraw

ORCID ID

Contact details

Royal Brompton & Harefield NHS Trust
Sydney Street
London
SW3 6NP
United Kingdom
+44 (0)20 7352 8121
P.Goldstraw@rbh.nthames.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0201184743

Study information

Scientific title

Acronym

Study hypothesis

1. The purpose of this study is to find out whether co-codamol or modified-release morphine provide better post-operative pain control following thoracotomy.
2. The secondary objective is to compare the incidence of complications and compare the compliance of the two analgesia regimens. Common complications include nausea, vomiting, pruritis (itchiness), sedation, lightheadedness, mobility and constipation.

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Signs and Symptoms: Pain

Intervention

Patients undergoing thoracotomy for the first time and not taking regular analgesia for another condition can be considered for this study.

Analgesia in the immediate post-operative period will be decided by consensus of surgeon, anaesthetist and the patient. They include epidural analgesia, PVB (paravertebral continuous analgesia) catheter and intravenous morphine either by continuous infusions or PCA. Every effort is made to ensure satisfactory pain relief.

Oral analgesia is commenced at least four hours before the paravertebral, epidural or IV morphine is stopped.

Patients will be randomised, by opening an envelope, into one of two groups to determine which of the two regimens they will receive:
Group 1: Co-codamol 30/500 2 tablets QDS PO. And unless contraindicated*: Diclofenac 75mg SR BD PO. For breakthrough pain: Tramadol 50−100mg QDS/PRN PO
Group 2: Paracetamol 1g QDS PO, MST Continus 20mg BD PO. And unless contraindicated*: Diclofenac 75mg SR bd PO. For breakthrough pain: Oramorph 10mg 1hrly/PRN PO

The MST dose should be adjusted on the second day to incorporate the 24 hour oramorph requirement.
* The contraindications for NSAIDs are gastroduodenal disease, renal impairment or a poor urine output. When used, patients should also receive omeprazole 20mg OD for gastric protection.

Added 28 August 2008: trial stopped due to poor recruitment.

Intervention type

Drug

Phase

Not Specified

Drug names

co-codamol and modified-release morphine sulphate

Primary outcome measures

1. Adequacy of pain control as measured by the visual analogue scale (0=no pain, 10=excruciating)
2. How frequently breakthrough analgesia is used overall satisfaction of pain control

Secondary outcome measures

Complications: nausea/vomiting, sedation, constipation, pruritis, mobility and compliance

Overall trial start date

21/06/2006

Overall trial end date

01/04/2008

Reason abandoned

Poor recruitment

Eligibility

Participant inclusion criteria

1. Patients >18 years
2. First-time thoracotomy patient
3. Informed consent

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

60 patients

Participant exclusion criteria

1. Patients <18 years
2. Pregnancy
3. Breast-feeding
4. Not able to give informed consent
5. Already taking analgesia at time of admission

Recruitment start date

21/06/2006

Recruitment end date

01/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Brompton & Harefield NHS Trust
London
SW3 6NP
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

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.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Royal Brompton and Harefield NHS Trust (UK), No External Funding, NHS R&D Support Funding

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

Publication citations

Additional files

Editorial Notes