Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000563662
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
Bowel recovery after colorectal surgery: A comparison of patient contolled analgesia with tramadol versus morphine
Scientific title
Bowel recovery after colorectal surgery: A comparison of patient contolled analgesia with tramadol versus morphine
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Return of normal gastrointestinal function 689 0
Condition category
Condition code
Oral and Gastrointestinal 764 764 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Post-operative analgesia via PCA containing either tramadol 600mg in 30mls n.saline or morphine 60mg in 30mls n. saline. PCA commenced in recovery and programmed to deliver an initial loading dose of 0.1ml study drug/kg body weight. Patient demand boluses then set at 0.5ml study drug with 5minute lockout and no dose limit. Bolus dose can be inreased to 1ml if analgesia inadequate. If increase in dose remains inadequate then patient will be withdrawn from trial and receive alternative analgesia as per Acute Pain Service protocol. Study duration < 1 week for each subject. Computer programme randomisation by pharmacy.
Intervention code [1] 410 0
None
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 967 0
Time to first flatus
Timepoint [1] 967 0
Secondary outcome [1] 1841 0
Time to first bowel motion.
Timepoint [1] 1841 0

Eligibility
Key inclusion criteria
ASA 1-3, elective colorectal surgery.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with known gastrointestinal tract disorders, previous abdominal radiotherapy, clinically relevant liver or renal impairment, chronic pre-op opiod use, patients unsuitable for PCA, planned epidural analgesia.

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, with no blocking or stratification
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/10/2001
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
36
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 844 0
Hospital
Name [1] 844 0
Department of Anaesthesia & Pain Medicine Royal Perth Hospital
Country [1] 844 0
Australia
Primary sponsor type
Individual
Name
Stephan Schug
Address
Country
Secondary sponsor category [1] 711 0
None
Name [1] 711 0
None
Address [1] 711 0
Country [1] 711 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 35413 0
Address 35413 0
Country 35413 0
Phone 35413 0
Fax 35413 0
Email 35413 0
Contact person for public queries
Name 9599 0
Stephan Schug
Address 9599 0
Pharmacology Unit
School of Medicine and Pharmacology
Royal Perth Hospital
GPO Box X2213
Perth WA 6847
Country 9599 0
Australia
Phone 9599 0
+61 8 92240201
Fax 9599 0
Email 9599 0
schug@cyllene.uwa.edu.au
Contact person for scientific queries
Name 527 0
Shauna Fatovich
Address 527 0
Department Anaesthesia and Pain Medicine
Royal Perth Hospital
Wellington Street
Perth WA 6000
Country 527 0
Australia
Phone 527 0
+61 8 92241036
Fax 527 0
Email 527 0
shauna.fatovich@health.wa.gov.au

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.