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Trial registered on ANZCTR
Registration number
ACTRN12610001016022
Ethics application status
Approved
Date submitted
18/11/2010
Date registered
19/11/2010
Date last updated
25/10/2013
Type of registration
Prospectively registered
Titles & IDs
Public title
Dexamethasone as a lower limb block adjuvant for foot and ankle surgery
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Scientific title
Dexamethasone as a lower limb block adjuvant for foot and ankle surgery to compare duration of pain relief post operatively
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Secondary ID [1]
253032
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No secondary ID
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Analgesia after foot/ankle surgery
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Condition category
Condition code
Anaesthesiology
258731
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0
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Anaesthetics
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Dexamethasone Group
A single operator will place all blocks in the operating room. Patients will be premedicated with oral acetaminophen 1 g one hour before surgery. Intravenous midazolam 2 mg, alfentanil 0.5 mg will be administered 5 min prior the establishment of general anaesthesia. A standardised lower limb block will be administered using standard landmarks. Patients will receive (using a computerised random number generator) 30 mL of bupivacaine 0.5% to which 2 ml of dexamethasone 8 mg will be added. Patients will receive a 2 ml intramuscular injection of 0.9% saline.
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Intervention code [1]
257560
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Treatment: Drugs
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Comparator / control treatment
Placebo Group
A single operator will place all blocks in the operating room. Patients will be premedicated with oral acetaminophen 1 g one hour before surgery. Intravenous midazolam 2 mg, alfentanil 0.5 mg will be administered 5 min prior the establishment of general anaesthesia. A standardised lower limb block will be administered using standard landmarks. Patients will receive (using a computerised random number generator) 30 mL of bupivacaine 0.5% to which 2 ml of 0.9% saline will be added. Patients will receive a 2 ml intramuscular injection of dexamethasone 8 mg.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Duration of analgesic effectiveness measured by time to first onset of operative site pain as assessed by patient interrogation.
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Assessment method [1]
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Timepoint [1]
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24 hours postoperatively, and again at 48 hours postoperatively for patients who have not experienced pain on postoperative day 1.
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Secondary outcome [1]
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Postoperative pain as assessed by patient questionnaire using numerical rating pain score (0-10).
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Assessment method [1]
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Timepoint [1]
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24 hours postoperatively, and again at 48 hours
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Secondary outcome [2]
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Patient satisfaction as assessed by patient questionnaire using a simple numerical rating satisfaction scale (0-10).
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Assessment method [2]
266383
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Timepoint [2]
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48 hours postoperatively
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Eligibility
Key inclusion criteria
Patients requiring surgical anaesthesia for foot/ankle surgery under the care of the principal and co-investigators.
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Minimum age
16
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria will include patient refusal for lower limb block, known neuropathy involving the limb undergoing surgery, and known allergy to amide local anaesthetic drugs.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Initial invitation to participate in the study will occur one week prior to surgery, where patients will be contacted by a research assistant and invited to participate. Written informed consent will be obtained from all patients. Assignment of the patient to one of the 2 groups will be delivered in sealed opaque envelopes.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random number generator will be used to assign the patient to one of the 2 groups.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/12/2010
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Actual
23/11/2010
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Date of last participant enrolment
Anticipated
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Actual
1/11/2012
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
3019
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Funding source category [1]
258009
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Charities/Societies/Foundations
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Name [1]
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Maurice & Phyllis Paykel Trust
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Address [1]
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P O Box 37760 Parnell Auckland 1151
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Country [1]
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New Zealand
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Primary sponsor type
Individual
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Name
Dr Michael Fredrickson
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Address
Anaesthesia Institute P O Box 109 199 Newmarket Auckland 1149
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Country
New Zealand
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Secondary sponsor category [1]
257202
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None
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Name [1]
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Address [1]
257202
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Country [1]
257202
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260012
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Northern Y Regional Ethics Commitee
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Ethics committee address [1]
260012
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P O Box 1031
Hamilton
Waikato Mail Centre 3240
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Ethics committee country [1]
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New Zealand
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Date submitted for ethics approval [1]
260012
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Approval date [1]
260012
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15/11/2010
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Ethics approval number [1]
260012
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NTY/10/09/071+073
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Summary
Brief summary
Epidural dexamethasone has been used for many years as a treatment for lower back pain and more recently for postoperative analgesia. Favourable results have also been demonstrated when dexamethasone is added to bupivacaine for interscalene nerve block: the time to first onset of operative site pain increased from 12 to 20 hours. However, perineural dexamethasone has not been studied when added to bupivacaine for lower limb peripheral nerve block.
The main limitation of the lower limb block for postoperative analgesia is its limited duration of effect; therefore, any therapeutic intervention effective in prolonging lower limb block duration has clinical value.
The primary aim of this study therefore is to test the hypothesis that the addition of dexamethasone 8 mg to 30 mL bupivacaine 0.5% administered via lower limb block will prolong the time to first pain after foot and ankle surgery conducted under general anaesthesia.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Michael Fredrickson
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Address
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Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
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Country
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New Zealand
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Phone
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+6495221117
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Michael Fredrickson
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Address
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Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
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Country
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New Zealand
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Phone
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+64 9 522 1117
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Fax
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+64 9 522 1127
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Michael Fredrickson
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Address
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Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
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Country
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New Zealand
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Phone
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+64 9 522 1117
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Fax
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+64 9 522 1127
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Email
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[email protected]
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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.
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