Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000227796
Ethics application status
Approved
Date submitted
7/02/2013
Date registered
26/02/2013
Date last updated
12/12/2022
Date data sharing statement initially provided
12/12/2022
Date results information initially provided
12/12/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
A comparison of pre-emptive sciatic nerve block and post-amputation sciatic nerve block and their effect on the incidence of phantom limb pain post-operatively
Scientific title
For patients receiving below knee amputations comparing pre-emptive sciatic nerve blocks and post-amputation sciatic nerve blocks and their effect on the incidence of phantom limb pain post-operatively
Secondary ID [1] 281768 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Phantom limb pain 288084 0
Condition category
Condition code
Anaesthesiology 288457 288457 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Pre-operative placement of sciatic nerve block (30ml of 0.25% bupivacaone) and catheter prior to commencement of below knee amputation. Local anaesthetic (3-5mL/hour 0.5% Bupivicaine) will continue to be infused continuously via the catheter for five days post-operatively (i.e. the infusion will continue around the clock).
Intervention code [1] 286312 0
Prevention
Intervention code [2] 286491 0
Treatment: Drugs
Comparator / control treatment
Intra-operative placement of sciatic nerve catheter (after below knee amputation) by the surgeon. This will be loaded by the surgeon with 30ml 0.25% bupivacaine and a continuous infusion of local anaesthetic via the catheter (3-5mL 0.5% bupivicaine) will continue for five days post-operatively (i.e the infusion will continue around the clock).
Control group
Active

Outcomes
Primary outcome [1] 288623 0
Incidence of phanton limb pain will be assessed with a 10 point questionnaire previously used in a survey study on phantom limb pain (Byrne K. Survey of phantom limb pain, phantm sensation and stump pain in Cambodian and New Zealand amputees. Pain Med 2011 May 12(5):794-98)
Timepoint [1] 288623 0
At 5 days, 6 months and 1 year post amputation
Secondary outcome [1] 300632 0
Opioid consumption over the 5 days post operatively will be taken from the patients prescription chart and PCA chart. Different opioids will be converted to morphine equivalents by accepted conversion factors.
Timepoint [1] 300632 0
At 5 days post operatively
Secondary outcome [2] 300633 0
Acute pain as assessed using a 11 point numberical rate scale (0 = no pain, 10= worst pain imaginable)
Timepoint [2] 300633 0
During admission within first five post operative days.

Eligibility
Key inclusion criteria
Patients having a Below Knee Amputation
ASA 1 - 4
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patient refusal
Allergy to Local Anaesthetic
Severe dementia
Inability to complete questionnaire
Inability to consent

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients booked for a below knee amputation at Waikato Hospital will be approached to participate in the study. Prior to the commencement of the study, a person independent of the study team will prepare 80 envelopes, 40 containing a piece of paper stating contol group, and 40 containing a piece of paper stating study group. These envelopes will then be ordered in a random fashion by the independent person. When the patient presents to theatre an envelope will be drawn by the attending anaesthetist and the patient will either be allocated to the control group or the study group. A member of the research team will place the sciatic nerve catheter in the study group, and the surgical team will place the catheter in the control group. A person blinding to the study allocation will be responsible for follow up of the patients.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The envelopes will alternately allocate a patient to the control group or intervention group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The incidence of phantom limb pain at 5 days, 6 months and one year would be compared with Chi-squared testing for categorical data (Phantom limb pain present – yes or no). The pain scores and fentanyl consumption would be described in terms of mean, standard deviation and range, and compared with student’s t test for comparing numerical data.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2013
Actual
26/08/2013
Date of last participant enrolment
Anticipated
22/06/2018
Actual
23/03/2020
Date of last data collection
Anticipated
22/06/2019
Actual
30/03/2021
Sample size
Target
80
Accrual to date
Final
80
Recruitment outside Australia
Country [1] 4855 0
New Zealand
State/province [1] 4855 0

Funding & Sponsors
Funding source category [1] 286577 0
Self funded/Unfunded
Name [1] 286577 0
Dr Kelly Byrne
Country [1] 286577 0
New Zealand
Primary sponsor type
Individual
Name
Dr Kelly Byrne
Address
Waikato Hospital
Pembroke Street
Hamilton
3204
Country
New Zealand
Secondary sponsor category [1] 285361 0
Individual
Name [1] 285361 0
Dr Kathryn Dawson
Address [1] 285361 0
Waikato Hospital
Pembroke Street
Hamilton
3204
Country [1] 285361 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288768 0
Health and Disability Ethics Committee
Ethics committee address [1] 288768 0
Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 288768 0
New Zealand
Date submitted for ethics approval [1] 288768 0
28/02/2013
Approval date [1] 288768 0
17/06/2013
Ethics approval number [1] 288768 0
13/NTB/47

Summary
Brief summary
Phantom limb pain after amputation is common and can be severe. This study will investigate whether blocking (anaesthetising) the patients sciatic nerve prior to having a below knee amputation will reduce the risk and or the severity of phantom limb pain.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37022 0
Dr Kelly Byrne
Address 37022 0
Dept. of Anaesthesia
Waikato Hospital
Pembroke St
Hamilton
3204
Country 37022 0
New Zealand
Phone 37022 0
+64 021 02224390
Fax 37022 0
Email 37022 0
kpa.byrne@gmail.com
Contact person for public queries
Name 37023 0
Dr Kathryn Dawson
Address 37023 0
Dept. of Anaesthesia
Waikato Hospital
Pembroke St
Hamilton
3204
Country 37023 0
New Zealand
Phone 37023 0
+64 021 327 845
Fax 37023 0
Email 37023 0
kathryndawson@gmail.com
Contact person for scientific queries
Name 37024 0
Dr Kelly Byrne
Address 37024 0
Dept. of Anaesthesia
Waikato Hospital
Pembroke St
Hamilton
3204
Country 37024 0
New Zealand
Phone 37024 0
+642102224390
Fax 37024 0
Email 37024 0
kpa.byrne@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Anonymized raw data from the trial if requested
When will data be available (start and end dates)?
Start date: 31/10/2019
End date: No end date determined
Available to whom?
Other researchers
Available for what types of analyses?
Any
How or where can data be obtained?
Emailing the corresponding author, kpa.byrne@gmail.com


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
17834Study protocol  kpa.byrne@gmail.com



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.