Trial Review

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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
Scientific title
Dexamethasone as a lower limb block adjuvant for foot and ankle surgery to compare duration of pain relief post operatively
Secondary ID [1] 253032 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Analgesia after foot/ankle surgery 258591 0
Condition category
Condition code
Anaesthesiology 258731 258731 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 257560 0
Treatment: Drugs
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.
Control group
Placebo

Outcomes
Primary outcome [1] 259597 0
Duration of analgesic effectiveness measured by time to first onset of operative site pain as assessed by patient interrogation.
Timepoint [1] 259597 0
24 hours postoperatively, and again at 48 hours postoperatively for patients who have not experienced pain on postoperative day 1.
Secondary outcome [1] 266231 0
Postoperative pain as assessed by patient questionnaire using numerical rating pain score (0-10).
Timepoint [1] 266231 0
24 hours postoperatively, and again at 48 hours
Secondary outcome [2] 266383 0
Patient satisfaction as assessed by patient questionnaire using a simple numerical rating satisfaction scale (0-10).
Timepoint [2] 266383 0
48 hours postoperatively

Eligibility
Key inclusion criteria
Patients requiring surgical anaesthesia for foot/ankle surgery under the care of the principal and co-investigators.
Minimum age
16 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/12/2010
Actual
23/11/2010
Date of last participant enrolment
Anticipated
Actual
1/11/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 3019 0
New Zealand
State/province [1] 3019 0
Auckland

Funding & Sponsors
Funding source category [1] 258009 0
Charities/Societies/Foundations
Name [1] 258009 0
Maurice & Phyllis Paykel Trust
Country [1] 258009 0
New Zealand
Primary sponsor type
Individual
Name
Dr Michael Fredrickson
Address
Anaesthesia Institute P O Box 109 199 Newmarket Auckland 1149
Country
New Zealand
Secondary sponsor category [1] 257202 0
None
Name [1] 257202 0
Address [1] 257202 0
Country [1] 257202 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260012 0
Northern Y Regional Ethics Commitee
Ethics committee address [1] 260012 0
P O Box 1031
Hamilton
Waikato Mail Centre 3240
Ethics committee country [1] 260012 0
New Zealand
Date submitted for ethics approval [1] 260012 0
Approval date [1] 260012 0
15/11/2010
Ethics approval number [1] 260012 0
NTY/10/09/071+073

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31876 0
Dr Michael Fredrickson
Address 31876 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 31876 0
New Zealand
Phone 31876 0
+6495221117
Fax 31876 0
Email 31876 0
[email protected]
Contact person for public queries
Name 15123 0
Michael Fredrickson
Address 15123 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 15123 0
New Zealand
Phone 15123 0
+64 9 522 1117
Fax 15123 0
+64 9 522 1127
Email 15123 0
[email protected]
Contact person for scientific queries
Name 6051 0
Michael Fredrickson
Address 6051 0
Anaesthesia Institute
P O Box 109 199
Newmarket
Auckland 1149
Country 6051 0
New Zealand
Phone 6051 0
+64 9 522 1117
Fax 6051 0
+64 9 522 1127
Email 6051 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.