Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611001166965
Ethics application status
Approved
Date submitted
5/11/2011
Date registered
8/11/2011
Date last updated
14/08/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of dexamethasone route of administration on ankle block duration and analgesia for foot and ankle surgery
Scientific title
Comparison of dexamethasone route of administration on ankle block duration and analgesia for foot and ankle surgery
Secondary ID [1] 273339 0
Nil
Universal Trial Number (UTN)
U1111-1125-6893
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Foot and ankle analgesia 279108 0
Condition category
Condition code
Anaesthesiology 279302 279302 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients undergoing elective ankle or foot surgery will receive an ultrasound guided ankle/foot block and be randomly allocated to one of three groups:

Arm 1
The intravenous dexamethasone group will receive 8 mg (2 ml) dexamethasone intravenously and 2 ml saline added to the ropivacaine ankle block.

Arm 2
The ankle block dexamethasone group will receive 8 mg (2 ml) dexamethasone added into the ropivacaine ankle block and 2 ml saline intravenously.
Intervention code [1] 283682 0
Treatment: Drugs
Comparator / control treatment
Arm 3
Receive no dexamethasone. The control group will receive 2 ml saline intravenously and 2 ml saline added to the ropivacaine ankle block.
Control group
Placebo

Outcomes
Primary outcome [1] 279911 0
Duration before analgesic effect of block wears off as reported by the patient
Timepoint [1] 279911 0
Checked at day 1 post-operatively as reported by the patient using a visual analogue scale
Secondary outcome [1] 294753 0
Pain score at surgical site when the block had worn off
Timepoint [1] 294753 0
Checked at day 1 post-operatively as reported by the patient using a visual analogue scale
Secondary outcome [2] 294756 0
Highest pain score as reported by the patient within 7 days
Timepoint [2] 294756 0
Checked at day 7 post-operatively as reported by the patient using a visual analogue scale
Secondary outcome [3] 294757 0
Nausea or vomiting
Timepoint [3] 294757 0
In post-operative recovery and on Day 7 as reported by the patient using patient self-report questionnaire
Secondary outcome [4] 294758 0
Use of analgesic medication during first 7 days post-operatively
Timepoint [4] 294758 0
Checked at day 7 post-operatively as reported by the patient using a patient self-report questionnaire
Secondary outcome [5] 294759 0
Pain score immediately post-operatively
Timepoint [5] 294759 0
Post anaesthetic care unit as reported by the patient using a visual analogue scale
Secondary outcome [6] 294760 0
Adverse events related to having the ankle block including nerve damage. These adverse events will not be known beforehand and this is to screen for potential adverse reactions which are not expected to occur.
Timepoint [6] 294760 0
Checked at day 1, day 7 and at the surgical postoperative consultation using patient self-report questionnaire

Eligibility
Key inclusion criteria
Elective patients having metatarsal osteotomy for foot surgery

American Society of Anaesthesiologists score 1-3
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
American Society of Anaesthesiologists score of 4 or greater

Contraindication to ankle block (patient refusal, coagulopathy, sepsis, local infection, allergy to ropivacaine)

Contraindication to dexamethasone (eg. known hypersensitivity, poorly controlled diabetes mellitus)

Pre-existing sensory deficit around the site of surgical intervention (eg. peripheral neuropathy, stroke)

Systemic glucocorticoid treatment of >10mg prednisolone (or equivalent) for two weeks or more within three months of surgery

Chronic opioid use define as >30mg oral morphine per day or equivalent (Fentanyl patch 12mcg/hr; buprenorphine 20mcg/hr; oxycodone >20mg/day)

Contraindication to non-steroidal anti-inflammatory drugs (NSAIDs) (eg. known hypersensitivity, active peptic ulcer disease, renal impairment, pregnancy)

Previous enrolment in this study

Inability to understand english

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)
Eligible patients will be provided with a patient information sheet at their preoperative visit. At the subsequent preoperative consultation, the surgeon will obtain verbal and written consent.

Subjects will be randomly allocated to a group using sealed opaque envelopes. A nurse who is not involved in the care of the enrolled subject will open the envelope and follow the instructions to draw up two syringes, one for the block and one for intravenous administration.

These syringes will be marked 'block' and 'intravenous' and given to the anaesthetist by another nurse.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using online computer software
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
Recruiting
Date of first participant enrolment
Anticipated
2/01/2012
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)
Recruitment postcode(s) [1] 4728 0
5006
Recruitment postcode(s) [2] 4729 0
5065

Funding & Sponsors
Funding source category [1] 284163 0
Hospital
Name [1] 284163 0
Burnside War Memorial Hospital
Country [1] 284163 0
Australia
Funding source category [2] 284164 0
Hospital
Name [2] 284164 0
The Memorial Hospital
Country [2] 284164 0
Australia
Primary sponsor type
Individual
Name
Ms Rachel Dawson
Address
Flinders Medical School
Flinders Drive
Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 269119 0
Individual
Name [1] 269119 0
Dr David McLeod
Address [1] 269119 0
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country [1] 269119 0
Australia
Secondary sponsor category [2] 269120 0
Individual
Name [2] 269120 0
Dr Jason Koerber
Address [2] 269120 0
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country [2] 269120 0
Australia
Secondary sponsor category [3] 269121 0
Individual
Name [3] 269121 0
Dr George Dracopoulos
Address [3] 269121 0
Orthopaedics SA
First Floor
1 Kermode Street
North Adelaide
South Australia 5006
Country [3] 269121 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286124 0
South Adelaide Health Service Research Ethics Committee
Ethics committee address [1] 286124 0
Research Ethics Office
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Ethics committee country [1] 286124 0
Australia
Date submitted for ethics approval [1] 286124 0
11/11/2011
Approval date [1] 286124 0
22/06/2012
Ethics approval number [1] 286124 0

Summary
Brief summary
Post operative pain following ankle and foot surgery is troublesome. It is common practice for regional anaesthetic blockade to be used to prolong post operative pain relief for about 14 hours. Dexamethasone has been shown to prolong regional blockade in the upper limb, but this has not been investigated in the lower limb. The optimal route of administration for dexamethasone has not been investigated and it is unknown whether there is advantage to administering dexamethasone intravenously, or mixed with the block. We aim to investigate whether dexamethasone can prolong regional anaesthesia in the lower limb and determine if there are differences in effect when administered intravenously compared with when it is added to the block.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33357 0
Address 33357 0
Country 33357 0
Phone 33357 0
Fax 33357 0
Email 33357 0
Contact person for public queries
Name 16604 0
Ms Rachel Dawson
Address 16604 0
Flinders Medical School
Flinders Drive
Bedford Park
South Australia 5042
Country 16604 0
Australia
Phone 16604 0
+61403275926
Fax 16604 0
Email 16604 0
[email protected]
Contact person for scientific queries
Name 7532 0
Ms Rachel Dawson
Address 7532 0
Flinders Medical School
Flinders Drive
Bedford Park
South Australia 5042
Country 7532 0
Australia
Phone 7532 0
+61403275926
Fax 7532 0
Email 7532 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

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