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
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