Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000848000
Ethics application status
Approved
Date submitted
5/10/2010
Date registered
8/10/2010
Date last updated
8/10/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Does the perioperative use of Gabapentin reduce analgesia requirements in patients having delayed open reduction and internal fixation of forearm or ankle fractures?
Scientific title
Do patients who are having delayed open reduction and internal fixation of forearm or ankle fractures and who are given gabapentin peri-operatively, when compared with patients not given gabapentin, show lower narcotic analgesic requirements
Secondary ID [1] 252797 0
None
Universal Trial Number (UTN)
U1111-1117-2960
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Peri-operative pain 258299 0
Forearm and ankle fractures 258346 0
Condition category
Condition code
Anaesthesiology 258493 258493 0 0
Pain management
Injuries and Accidents 258530 258530 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-operative and post-operative treatment with gabapentin for 24 hours. Preoperative dose would normally be 600 mg orally 30 minutes prior to surgery with 300 mg being given orally 8 hourly for 24 hours following completion of surgery. The doses would need to be reduced if a patient with moderate or worse renal failure was recruited.
Intervention code [1] 257322 0
Treatment: Drugs
Comparator / control treatment
Placebo - indistinguishable gelatin capsule filled with starch
Control group
Placebo

Outcomes
Primary outcome [1] 259328 0
Total dose of fentanyl used over period of study - intra-operatively and via Patient Controlled Analgesia (PCA) device
Timepoint [1] 259328 0
After 24 hours use of PCA, started immediately after surgery.
Secondary outcome [1] 265776 0
Nausea/Vomiting using a score of 0-3
Timepoint [1] 265776 0
At any time following the administration of the initial dose of gabapentin until up to 24 hours of subsequent gabapentin use.
Secondary outcome [2] 265777 0
Dizziness Yes/No
Timepoint [2] 265777 0
At any time following the administration of the initial dose of gabapentin until up to 24 hours of subsequent gabapentin use.
Secondary outcome [3] 265778 0
Sedation (using a score combining sedation (0-2) and rousability(Yes/No))
Timepoint [3] 265778 0
At any time following the administration of the initial dose of gabapentin until up to 24 hours of subsequent gabapentin use.

Eligibility
Key inclusion criteria
Have to have a fracture of the wrist or ankle that is to be treated by internal fixation and be able to understand how to use a PCA device.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy, Non-adult patients due to the hospital being non-paediatric, any patient unable to use PCA.

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)
Recruitment would be from patients presented for emergency surgery. This is of relatively low urgency and would allow adequate time for reflection after the subjects were approached. If recruitment was succesful then allocation is concealed by the use of central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257761 0
Hospital
Name [1] 257761 0
Princess Alexandra Hospital
Country [1] 257761 0
Australia
Primary sponsor type
Individual
Name
Iain Salkield
Address
c/- Dept, of Anaesthesia
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane
Queensland 4102
Country
Australia
Secondary sponsor category [1] 256973 0
None
Name [1] 256973 0
Address [1] 256973 0
Country [1] 256973 0
Other collaborator category [1] 251538 0
Individual
Name [1] 251538 0
Benjamin Cerutti
Address [1] 251538 0
c/- Dept, of Anaesthesia
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Brisbane
Queensland 4102
Country [1] 251538 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259804 0
Metro South Health Service District Human Research Ethics Committee (HREC)
Ethics committee address [1] 259804 0
Ethics committee country [1] 259804 0
Australia
Date submitted for ethics approval [1] 259804 0
Approval date [1] 259804 0
Ethics approval number [1] 259804 0
HREC/10/QPAH/87

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

Contacts
Principal investigator
Name 31720 0
Address 31720 0
Country 31720 0
Phone 31720 0
Fax 31720 0
Email 31720 0
Contact person for public queries
Name 14967 0
Iain Salkield
Address 14967 0
c/- Dept. of Anaesthesia
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Queensland 4102
Country 14967 0
Australia
Phone 14967 0
+61 (0)427 567 931
Fax 14967 0
+61 7 3240 5102
Email 14967 0
Iain_Salkield@health.qld.gov.au
Contact person for scientific queries
Name 5895 0
Iain Salkield
Address 5895 0
c/- Dept. of Anaesthesia
Princess Alexandra Hospital
Ipswich Road
Woolloongabba
Queensland 4102
Country 5895 0
Australia
Phone 5895 0
+61 (0)427 567 931
Fax 5895 0
+61 7 3240 5102
Email 5895 0
Iain_Salkield@health.qld.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.