Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000537853
Ethics application status
Approved
Date submitted
21/05/2012
Date registered
21/05/2012
Date last updated
21/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
One injection in the palm versus two injections on the back of the hand to numb the finger for minor surgery
Scientific title
Comparing the pain of injection of a single injection palmar subcutaneous nerve block with a double injection dorsal digital nerve block for digital anaesthesia in patients who present to the emergency department with finger injuries.
Secondary ID [1] 280521 0
Nil
Universal Trial Number (UTN)
U1111-1130-9376
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Finger injuries 286508 0
Condition category
Condition code
Injuries and Accidents 286768 286768 0 0
Fractures
Injuries and Accidents 286769 286769 0 0
Other injuries and accidents
Anaesthesiology 286779 286779 0 0
Anaesthetics

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive a palmar subcutaneous injection at the level of the first annular pulley of the flexor tendon as outlined by Myers, ASEM 2011; www.myhand.com.au)

(1) Aseptic injection technique
(2) Surface markings used are the junction of the line joining the two palmar creases and another line over the flexor sheath of each finger.
(3) A 3.75-cm, 25 gauge needle inserted subcutaneously above the tendon sheath.
(4) Avoid injection into crease
(5) Patient is asked to move their finger to determine if the needle is in the tendon sheath. If the needle moves then the needle is in the tendon. The needle is then pulled back 1mm and retested until needle is in a subcutaneous location
(6) Inject 3mls of lignocaine 1% without adrenaline
(7) Massage local anaesthetic to encourage dorsal
(8) If proximal dorsal anaesthesia not provided by above technique and is required a single subcutaneous injection over extensor tendon sheath may be used
(9) Anaesthesia tested after 5 minutes
(10) If anaesthesia is not adequate for procedure then subsequent repeat anaesthetic injection will be required. This will be up to the treating clinician to perform either a single injection in the back of the hand in the skin overlying over the extensor tendon or a double injection digital nerve block.
Intervention code [1] 284894 0
Treatment: Other
Intervention code [2] 284897 0
Treatment: Drugs
Comparator / control treatment
The standard care group will receive a dorsal digital nerve block as detailed by Roberts, (Clinical Procedures Emergency Medicine, 2009).
This technique is as follows:
(1) Aseptic injection technique
(2) A 3.75-cm, 25 gauge needle inserted at the web space, just distal to the Metacarpal phalangeal joint (MCPJ) at the lateral edge of the bone
(3) Wheal of 0.5 to 1mL of lignocaine 1% without epinephrine is injected at this level with aim of blocking block the dorsal digital nerve
(4) The needle is then passed lateral to the bone and toward the palmar surface until the palmar skin starts to tent slightly.
(5) The needle is withdrawn 1 mm and aspirated to check for an inadvertent intravenous position, and 0.5 to 1.5 mL of anaesthetic is injected. This procedure is repeated on the opposite side of the finger.
(5) Result in circumferential band of anaesthesia at the base of the finger.
(6) Firm massage of the injected area for 15 to 30 seconds enhances diffusion of the anaesthetic through the tissue to the nerves.
(7) Anaesthesia is tested after 5 minutes
(8) If anaesthesia is not adequate for the procedure then subsequent repeat anaesthetic injection will be required. This will be up to the treating clinician to perform either a single injection in the back of the hand in the skin overlying over the extensor tendon or a repeat of the double injection digital nerve block.
Control group
Active

Outcomes
Primary outcome [1] 287154 0
The primary outcome will be patient reported pain of the procedure for digital anaesthesia, , pain will be reported on a 100 point visual analogue scale.
Timepoint [1] 287154 0
This will be measured 5 minutes after the anaesthetic injection by a medical officer blinded to the treatment group.
Secondary outcome [1] 297509 0
Success of anaesthesia. Success of anaesthesia will be defined as the ability to perform the procedure such as wound debridement, suture of wound, fracture or dislocation reduction without pain.
Timepoint [1] 297509 0
This will be tested prior to the procedure by a medical officer blinded to the treatment group by testing sharp sensation at 5 minutes following the injection.
Secondary outcome [2] 297510 0
Pain relief from the injection. Pain associated their injury will be measured using a 100 point VAS before after the injection
Timepoint [2] 297510 0
Pain scores will be measured at 5 and 10 minutes following the injection.
Secondary outcome [3] 297511 0
Patient Satisfaction with the procedure will be measured by a physician blinded to the treatment group. Satisfaction will be assessed using a 5 point likert scale ranging from Very Unsatisfied to Very Satisfied.
Timepoint [3] 297511 0
This will be recorded following the assessment or treatment of the injury and prior to disposition home or admission to the ward.
Secondary outcome [4] 297512 0
Complications. The following will be recorded as complications:

Ongoing pain in the finger; defined as self-reported pain in the finger following the procedure at the site of the infiltration of the local anaesthetic. This will be assessed at the time of discharge or admission and at 1 week post injury

Infection, defined as erythema and/or swelling at the site of the nerve block injection.

Nerve injury which is defined as reduced or absent sensation in the distribution of the digital nerve that is not attributed to the injury itself.
Timepoint [4] 297512 0
Complications will be assessed at 1 week post procedure via a phone call follow up. The individual making the telephone call will be blinded to the treatment group.

Eligibility
Key inclusion criteria
Patients will be included if they

1. are aged >= 18 years old and
2. present with a finger injury requiring digital anaesthesia
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded if they:

1. Have a digital nerve injury proximal to distal interphalangeal joint. Such patients are excluded because assessment of the distal sensation of the finger is performed by the hand surgical team as these injuries benefit from operative intervention.
2. Have peripheral neuropathy or vasculopathy. Peripheral neuropathy will confound the assessment of pain of the injection and all pain scores. Vasculopathy will result in reduced blood flow to the digit and may result in increased risk vascular compromise following digital anaesthesia.
3. Are unwilling or unable to consent. This includes patients with a psychotic illness that would impair their ability to consent and patients with alcohol or drug intoxication.
4. Have a tendon sheath infection as digital nerve block may promote the spread of the infection
5. Skin disease such as eczema overlying the injection site
6. Have an allergy to lignocaine

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)
Patients will be identified by the triage nurse or treating doctor as being suitable candidates and a trial information sheet provided to the patient. Informed consent will be obtained by a member of the research team or the treating doctor if one of the research team is not available.

The investigators will generate the randomisation sequence using a table of random numbers. A permutated block randomisation technique with variable block sizes will be used to allocate eligible patients to each of the two groups. The treatment allocation will be put in sequentially numbered opaque tamper proof envelopes.

Once consented, they will open the envelopes to identify the treatment group. Those performing the recruitment will be unaware of the treatment allocation until after consent.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A permutated block randomisation method with variable block sizes will be used to allocate eligible patients to each of the two groups. We will utilise sequentially numbered envelopes containing the treatment allocations that will be sealed until intervention assignment at enrolment.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2012
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)

Funding & Sponsors
Funding source category [1] 285281 0
Self funded/Unfunded
Name [1] 285281 0
Country [1] 285281 0
Primary sponsor type
Hospital
Name
Royal Brisbane and Womens Hospital
Address
Emergency Department Royal Brisbane and Womens Hospital
Butterfield St, Herston
Brisbane, QLD 4029.
Country
Australia
Secondary sponsor category [1] 284141 0
None
Name [1] 284141 0
Address [1] 284141 0
Country [1] 284141 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287296 0
RBWH Ethics Commitee
Ethics committee address [1] 287296 0
Ethics committee country [1] 287296 0
Australia
Date submitted for ethics approval [1] 287296 0
27/02/2009
Approval date [1] 287296 0
01/05/2012
Ethics approval number [1] 287296 0
HREC/12/QRBW/61

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34201 0
Address 34201 0
Country 34201 0
Phone 34201 0
Fax 34201 0
Email 34201 0
Contact person for public queries
Name 17448 0
Shane Martin
Address 17448 0
Department of Emergency Medicine, Royal Brisbane & Women’s Hospital
Butterfield Street, Herston
Brisbane,
Queensland, 4029
Country 17448 0
Australia
Phone 17448 0
+6173636 7901
Fax 17448 0
+6173636 6322
Email 17448 0
[email protected]
Contact person for scientific queries
Name 8376 0
Shane Martin
Address 8376 0
Department of Emergency Medicine, Royal Brisbane & Women’s Hospital
Butterfield Street, Herston
Brisbane,
Queensland, 4029
Country 8376 0
Australia
Phone 8376 0
+6173636 7901
Fax 8376 0
+6173636 6322
Email 8376 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
SourceTitleYear of PublicationDOI
EmbaseDouble-dorsal versus single-volar digital subcutaneous anaesthetic injection for finger injuries in the emergency department: A randomised controlled trial.2016https://dx.doi.org/10.1111/1742-6723.12559
N.B. These documents automatically identified may not have been verified by the study sponsor.