Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12610000925044
Ethics application status
Approved
Date submitted
27/09/2010
Date registered
1/11/2010
Date last updated
3/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of ultrasound guided and nerve stimulator assisted popliteal nerve blocks for foot surgery
Scientific title
In patients undergoing popliteal nerve blocks for foot surgery, is ultrasound guided administration of the block as good as or better than a nerve stimulator for providing intraoperative and postoperative pain relief?
Secondary ID [1] 252776 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pain relief during and after foot surgery 258276 0
Condition category
Condition code
Anaesthesiology 258468 258468 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Ultrasound nerve localization with a Sonosite Nanomaxx ultrasound system using an L38n ultrasound probe in the 5-10MHz range or

Once the nerves have been adequately localized in the transverse plane below the level of the bifurcation. A double injection - a block of the Common Peroneal nerve and Posterior Tibial nerve is performed, the saphenous nerve is also blocked at the level of the knee

The local anaesthetic agent used is 20ml of Ropivicaine 0.75%
The block is inserted prior to prepping and draping
Intervention code [1] 257293 0
Treatment: Other
Comparator / control treatment
Lateral popliteal block using Nerve stimulation using a Stimuplex A nerve stimulator with a 22G 50mm insulated needle.
A double injection technique to the posterior tibial then the common peroneal is performed after approriate evoked motor response is obtained and the stimulator is reduced to 0.5mA. A sapheneous nerve block at the knee is also performed
20ml of 0.75% Ropivicaine is used
Control group
Active

Outcomes
Primary outcome [1] 259313 0
Post procedure analgesic requirements. The analgesic and dose will be recorded on a form by the anaesthetist intraoperatively and by nursing staff in recovery and then on the ward
Timepoint [1] 259313 0
recorded during operation, at 2 hours, 4 hours and 16 hours post block
Secondary outcome [1] 265734 0
Speed to perform block
Timepoint [1] 265734 0
Measured intraoperatively
Secondary outcome [2] 265759 0
Time to onset before 4 hours
Timepoint [2] 265759 0
Assessment of the completeness of the block at 4 hours to be made by the nursing staff
Secondary outcome [3] 265760 0
Patient satisfaction
Timepoint [3] 265760 0
Patients will be asked by the nursing staff on discharge if they were satisfied with the block and analgesia that it provided. This will be recorded on a form
Secondary outcome [4] 265761 0
Residual neurological deficit at 8 weeks
Timepoint [4] 265761 0
At a clinic review at 8 weeks a detailed motor and sensory examination will be recorded on a form to assess any deficit whihc may be block related.

Eligibility
Key inclusion criteria
Foot Surgery which will last <90 mins and require an overnight stay.
Calf tourniquet
>18 yrs
American Society of Anesthesiologists (ASA) score I - III
Minimum age
18 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Known neuropathies
Diabetics with a neuropathy
Patients receiving muscle relaxant
Coagulopathy or on Anticoagulants
Infection / Skin problems precluding injection of block
Previous surgery in the popliteal region
Allergy to local anaesthetic
Patients on opioids for chronic analgesic therapy
Patients with a known Chronic regional pain syndrome (CRPS) / neuroma
Renal / liver failure where post operative analgesia can not be used

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)
The patients who meet inclusion criteria at teh time of booking for suregery will be given an information and consent form and asked to participate.
On teh day of surgery a sealed envelope will randomise the patient to either recieve the popliteal block using ultrasound or nerve stimulation assistance.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2011
Actual
7/02/2011
Date of last participant enrolment
Anticipated
1/12/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257729 0
Self funded/Unfunded
Name [1] 257729 0
Mr Harvinder Bedi
Country [1] 257729 0
Australia
Primary sponsor type
Individual
Name
Mr Harvinder Bedi
Address
Orthosport
Suite 61 Level 6
Epworth Eastern Hospital
1 Arnold Street
Boxhill
Melbourne
VIC
Country
Australia
Secondary sponsor category [1] 256944 0
None
Name [1] 256944 0
Address [1] 256944 0
Country [1] 256944 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259780 0
St Vincents Hospital Ethics Committee
Ethics committee address [1] 259780 0
Ethics committee country [1] 259780 0
Australia
Date submitted for ethics approval [1] 259780 0
01/10/2010
Approval date [1] 259780 0
21/12/2010
Ethics approval number [1] 259780 0
HREC/A -155/10

Summary
Brief summary
This project has been designed to investigate whether one particular method of administering local anaesthetic around the knee in order to provide pain relief for patients undergoing foot surgery is better than the other.
A routine part of anaesthesia for foot surgery performed in our unit is to perform a popliteal block. This involves injecting local anaesthetic around the nerves behind the knee to numb the foot and provide pain relief both during and after the operation. This block is performed either using an ultrasound machine to visualise the nerves or a nerve stimulator which stimulates the nerve. Both allow the anaesthetist to know the correct position to inject the local anaesthetic.
We are planning to randomly allocate patients undergoing foot surgery to receive the block either with the ultrasound machine or with the nerve stimulator.
We will then use a form to collect information about pain and pain relief requirements whilst the patient is in hospital to assess the efficacy of the block. We will also collect information about the length time to perform each block and patient satisfaction.
Patients will be seen at routine follow up at 8 weeks and assessed to see if there are any ongoing problems related to the nerve block.
We will analyse the data to see if one technique is superior to the other and modify our practise as appropriate.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31708 0
Mr Harvinder Bedi
Address 31708 0
Orthosport Suite 61 Level 6 Epworth Eastern Hospital 1 Arnold Street Boxhill Melbourne VIC 3128
Country 31708 0
Australia
Phone 31708 0
+61 3 9890 0494
Fax 31708 0
Email 31708 0
[email protected]
Contact person for public queries
Name 14955 0
Mr Mr Hamish Curry
Address 14955 0
Orthosport
Suite 61 Level 6
Epworth Eastern Hospital
1 Arnold Street
Boxhill
Melbourne
VIC 3128
Country 14955 0
Australia
Phone 14955 0
+61 3 9890 0494
Fax 14955 0
Email 14955 0
[email protected]
Contact person for scientific queries
Name 5883 0
Mr Mr Hamish Curry
Address 5883 0
Orthosport
Suite 61 Level 6
Epworth Eastern Hospital
1 Arnold Street
Boxhill
Melbourne
VIC 3128
Country 5883 0
Australia
Phone 5883 0
+61 3 9890 0494
Fax 5883 0
Email 5883 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.