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Trial registered on ANZCTR


Registration number
ACTRN12614001066673
Ethics application status
Approved
Date submitted
21/09/2014
Date registered
3/10/2014
Date last updated
11/02/2020
Date data sharing statement initially provided
11/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of the intercostobrachial nerve block to reduce upper limb tourniquet pain in patients undergoing forearm surgery
Scientific title
Effectiveness of the intercostobrachial nerve block compared to a placebo to reduce the upper limb tourniquet pain in patients undergoing forearm surgery
Secondary ID [1] 285378 0
None
Universal Trial Number (UTN)
U1111-1162-0179
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tourniquet Pain during forearm surgery 293109 0
Condition category
Condition code
Anaesthesiology 293382 293382 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intercostobrachial nerve block will be performed with 5 ml solution (study drug which is either 1% lignocaine or saline as placebo). At 5 minutes after the intercostobrachial nerve block with the study drug, the sensation on the medial site of the forearm will be checked with ice. Then,axillary brachial plexus block will be performed with 20 ml of local anaesthetics (10 ml of 2% lignocaine and 10 ml of 0.75% ropivacaine).
A tourniquet will be inflated just before starting the surgery.
The pain score will be assessed every 5 minutes after the tourniquet is inflated.
Intervention code [1] 290291 0
Treatment: Drugs
Comparator / control treatment
Participants in the control group undergo intercostobrachial nerve block with placebo (normal saline) as well as axillary brachial plexus block with 10 ml of 2% lignocaine and 10 ml of 0.75% ropivacaine.
Control group
Placebo

Outcomes
Primary outcome [1] 293211 0
Effectiveness of intercostobrachial nerve block will be assessed with 100mm visual analogue scale.
Timepoint [1] 293211 0
Timepoints at which the corresponding primary outcome (pain relief from tourniquet pain) is every 5 minutes at and from the point of a tourniquet being inflated until the tourniquet being deflated.
Secondary outcome [1] 310600 0
None
Timepoint [1] 310600 0
None

Eligibility
Key inclusion criteria
Forearm operation
Suitable for axillary brachial plexus nerve block
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age less than 18
Weight less than 50 kg
Unable to give informed consent themselves
Intravenous drug users
Chronic pain patients
Those who are contraindicated to the nerve block
Expected tourniquet inflating time is less than 45 minutes

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (Research Randomizer).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 3007 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 8719 0
6000 - Perth

Funding & Sponsors
Funding source category [1] 289988 0
Hospital
Name [1] 289988 0
Department of anaesthesia and pain medicine at Royal Perth Hospital
Address [1] 289988 0
197 Wellington Street, Perth, WA 6009
Country [1] 289988 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia and Pain Medicine at Royal Perth Hospital
Address
197 Wellington Street, Perth, WA 6009
Country
Australia
Secondary sponsor category [1] 288673 0
None
Name [1] 288673 0
Address [1] 288673 0
Country [1] 288673 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291696 0
Royal Perth Hospital Ethics Committee
Ethics committee address [1] 291696 0
197 Wellington Street, Perth, WA 6000
Ethics committee country [1] 291696 0
Australia
Date submitted for ethics approval [1] 291696 0
09/12/2013
Approval date [1] 291696 0
29/04/2014
Ethics approval number [1] 291696 0
REG13-176

Summary
Brief summary
Pneumatic tourniquet has been used in hands and forearm surgery to reduce blood loss. When the tourniquet is used for a longer period under general anaesthesia, rapid heart rate and high blood pressure can be observed. This is often referred to as ‘tourniquet pain’. In awake patients, tourniquet pain is experienced as a vague, dull aching pain in the affected limb associated with an increased blood pressure.
Intercostobrachial nerve supplies sensation to the skin of the armpit and inner side of the upper arm. The nerve lies just below the skin and can be easily blocked to help with upper arm tourniquet pain. The purpose of this study is to determine the efficacy of intercostobrachial nerve block which could reduce pain from tourniquet on the upper arm.

Patients who suit the participation in the study will be randomised to either group (intercostobrachial nerve block with lignocaine or saline). The pain score will be assessed every 5 minutes after the touniquet is inflated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51590 0
Dr Ganeshanathan Vyhunthan
Address 51590 0
Royal Perth Hospital
Department of anaesthesia and pain medicine
197 Wellington Street, Perth, WA 6000
Country 51590 0
Australia
Phone 51590 0
+61892241036
Fax 51590 0
Email 51590 0
drganesh0777@gmail.com
Contact person for public queries
Name 51591 0
Prof Frank van Bockxmeer
Address 51591 0
Royal Perth Hospital
197 Wellington Street, Perth, WA 6000
Country 51591 0
Australia
Phone 51591 0
+61892241036
Fax 51591 0
Email 51591 0
Frank.VanBockxmeer@health.wa.gov.au
Contact person for scientific queries
Name 51592 0
Prof Krishna Boddu
Address 51592 0
Royal Perth Hospital
Department of anaesthesia and pain medicine
197 Wellington Street, Perth, WA 6000
Country 51592 0
Australia
Phone 51592 0
+61892241036
Fax 51592 0
Email 51592 0
Krishna.Boddu@health.wa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results