Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12605000564651
Ethics application status
Approved
Date submitted
8/09/2005
Date registered
30/09/2005
Date last updated
30/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Analgesia after major thoracic or abdominal surgery: A comparison of patient controlled analgesia with morphine versus tramadol versus morphine/tramadol combination
Scientific title
Analgesia after major thoracic or abdominal surgery: A comparison of patient controlled analgesia with morphine versus tramadol versus morphine/tramadol combination
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post operative pain 690 0
Condition category
Condition code
Anaesthesiology 765 765 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Paracoxib 40mg given shortly before end of surgery. PCA commenced in recovery. Study syringes contain either morphine 60mg in 30mls n.saline or tramadol 600mg in 30mls n.saline or mophine 30mgs and tramadol 300mg in n.saline. PCA pump set at 2mg/ml, 1mg bolus,5 minute lockout and no 4 hour dose limit. Inadequate analgesia treated with fentanyl. Study period 48 hours per subject. Computer generated randomisation by pharmacy.
Intervention code [1] 414 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 968 0
Total analgesic consumption in each group in 48 hours
Timepoint [1] 968 0
Secondary outcome [1] 1842 0
None
Timepoint [1] 1842 0

Eligibility
Key inclusion criteria
ASA 1-3, elective major thoracic or abdominal surgery requiring parental opiod analgesia.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Clinically relevant liver or renal impairment, chronic pre-op opiod use, patients unsuitable for PCA, planned epidural analgesia, allergy to morphine, tramadol or paracoxib.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software, without blocking or stratification
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
90
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 845 0
Hospital
Name [1] 845 0
Department of Anaesthesia & Pain Medicine Royal Perth Hospital
Country [1] 845 0
Australia
Primary sponsor type
Individual
Name
Stephan Schug
Address
Country
Secondary sponsor category [1] 712 0
None
Name [1] 712 0
None
Address [1] 712 0
Country [1] 712 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35890 0
Address 35890 0
Country 35890 0
Phone 35890 0
Fax 35890 0
Email 35890 0
Contact person for public queries
Name 9603 0
Stephan Schug
Address 9603 0
Pharmacology Unit
School of Medicine & Pharmacology
Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country 9603 0
Australia
Phone 9603 0
+61 8 92240201
Fax 9603 0
Email 9603 0
[email protected]
Contact person for scientific queries
Name 531 0
Shauna Fatovich
Address 531 0
Department Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 531 0
Australia
Phone 531 0
+61 8 92241036
Fax 531 0
Email 531 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.