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
ACTRN12617001054303
Ethics application status
Approved
Date submitted
17/07/2017
Date registered
19/07/2017
Date last updated
24/03/2021
Date data sharing statement initially provided
24/03/2021
Date results information initially provided
24/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound-Guided regional Anaesthesia in Patients receiving Dressing Change After split-Skin grafting for Upper Limb burn Injuries: A Prospective Randomized Study
Scientific title
Ultrasound-Guided regional Anaesthesia in Patients receiving Dressing Change After split-Skin grafting for Upper Limb burn Injuries: A Prospective Randomized Study
Secondary ID [1] 292443 0
N/A
Universal Trial Number (UTN)
N/A
Trial acronym
REPAIR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Burn Pain 304055 0
Condition category
Condition code
Anaesthesiology 303380 303380 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Following institutional ethical approval, 20 participants will be sourced, written consent will be obtained and they will be randomly divided into two groups (10 patients in each) with a control and interventional group. Group one (I) will receive standard opioid administration as per their treating team for pain associated with change of dressing to burn sites on the upper limbs . Group two (II) will receive will receive standard opioid intervention with the addition of an ultrasound guided single-shot axillary brachial plexus block (ABPB) using 0.375% ropivacaine of 20-30mls. All patients will be charted post-procedural pain relief and antiemetics as per their treating team, and the addition of regional blockade will not affect availability of pain relief in any way.
The interventional group will receive their ABPB in the designated anaesthetic block room prior to their dressing change. Blocks will be placed by qualified and experienced anaesthetic fellows and consultants under direct ultrasound guidance, employing aseptic technique, and according to standard practice.

The axillary brachial plexus block provides reliable analgesia to the upper limb, forearm and hand. Patients will be connected to observational monitoring including non-invasive blood pressure, electrocardiogram and pulse oximetry, in addition to oxygen delivery. Each patient will require intravenous access, and prior to the block performance, patients will receive pre-medication as needed. The pre-medication is given as a relaxant, not to induce full sedation. The block will be administered as follows:

• The patient is positioned in a recumbent position of about 45 degrees. The patients shoulder is abducted and arm extended to reveal the axilla. The probe is placed transverse to the axillary artery to obtain sufficient view of the axillary artery, axillary veins and 4 nerves of the plexus (radial nerve, ulnar nerve, median nerve and musculocutaneous nerve).
• The 50mm 22g short bevel block needle is inserted in the lateral aspect of the upper arm and using an in-plane ultrasound guided approach to ensure infiltration of local anaesthetic around each nerve.
The efficacy of the block will then be judged based on the three point sensory and function motor scale. Skin sensation will be assessed, along with functional capacity. This will determine if the block is adequate or requires additional administration of local anaesthetic.

Intervention code [1] 298622 0
Treatment: Other
Intervention code [2] 298623 0
Treatment: Drugs
Comparator / control treatment
Group one (I) will receive standard opioid administration as per their treating team for the treatment of pain associated with dressing changes to the upper limb on patients who have sustained burn related injuries. The prescription of medications for pain relief will vary from patient to patients and will be judged by the burns treating team as required.
Control group
Active

Outcomes
Primary outcome [1] 302766 0
The efficacy of regional anaesthesia for the treatment of pain associated with dressing change in patients suffering burn related injuries will be judged based on the 10 point numeric pain scale.
Timepoint [1] 302766 0
Primary time point will include data collection during the immediate dressing change phase- patient pain will be recorded immediately before, during and after the dressing change procedure. Then daily for 7 days post dressing change or until discharge if that occurs sooner.
Primary outcome [2] 302767 0
The efficacy of regional anaesthesia will be judged based on rescue analgesia and opioid equivalents. This data will be collected prospectively and through review of medical records.
Timepoint [2] 302767 0
Primary time point will include data collection covering the 24 hours before dressing change procedure, requirements during the procedure, and then daily requirements for 7 days post dressing change or until discharge if that occurs sooner.
Secondary outcome [1] 336948 0
The efficacy of regional anaesthesia will be judged pre-operatively by a three point sensory and function motor scale. This scale is routinely utilised in regional anaesthesia assessment and has been employed across a variety of regional anaesthesia studies. It is a known method of assessment, though not a validated tool.
Timepoint [1] 336948 0
Assessment will take place 10 minutes, 20 minutes, and 30 minutes after the regional block has been placed and before the participants commence their dressing change procedure.
Secondary outcome [2] 348806 0
Patient functionality in terms of pain, self-efficacy and experience will be evaluated.
Timepoint [2] 348806 0
6 months post-procedure, patients will be followed up in the community setting via administration of 2 questionnaires (The Modified Brief Pain Inventory short form and EQ-5D-5L) and one semi-structured phone interview.

Eligibility
Key inclusion criteria
- Patients aged >17 years
- Split Skin Grafting to their upper limbs
- ASA 1-3
- Patients remaining in hospital until change of dressing
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patients with burns >20%
- Patients with significant burns requiring grafting to areas other than the upper limbs
- History of local anaesthetic allergy
- Contraindication to regional anaesthesia
- Severe respiratory disease
- Inability to give informed consent
- Physiological/neurological shoulder/nerve deficits
- Significant coagulopathy and anticoagulant treatment

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 envelopes. Participating clinicians are given randomly generated treatment allocations within sealed opaque envelopes. Once a patient has consented to enter the trial an envelope is opened and the patient is then offered the allocated treatment regimen.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomization, non-stratified, conducted through the use of Excel randomization and performed by an independent third party.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The sample size was derived from a type I error probability of a=0.05, a power to reject the null hypothesis of 0.80 and equal numbers of patients in each group were used. The calculations are based on comparing VAS measured on a scale of 0-10 between two groups based on a Mann-Whitney U test. SAS 9.4 was used for the calculations.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/07/2018
Actual
28/08/2018
Date of last participant enrolment
Anticipated
28/12/2018
Actual
14/10/2020
Date of last data collection
Anticipated
28/06/2019
Actual
19/10/2020
Sample size
Target
20
Accrual to date
Final
20
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8542 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 16639 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 297009 0
Hospital
Name [1] 297009 0
Department of Anaesthetics and Perioperative Medicine, Royal Brisbane and Womens Hospital
Country [1] 297009 0
Australia
Primary sponsor type
Individual
Name
Cienwen Town
Address
Department of Anaesthetics and Perioperative Medicine, Royal Brisbane and Women's Hospital. Butterfield Street and Bowen Bridge Road, Herston, QLD 4029.
Country
Australia
Secondary sponsor category [1] 296010 0
Individual
Name [1] 296010 0
James Johnson
Address [1] 296010 0
Department of Anaesthetics and Perioperative Medicine, Royal Brisbane and Women's Hospital. Butterfield Street and Bowen Bridge Road, Herston, QLD 4029.
Country [1] 296010 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298199 0
Royal Brisbane and Womens Hospital Human Research Ethics Committee EC00172
Ethics committee address [1] 298199 0
Royal Brisbane and Womens Hospital Human Research Ethics Committee EC00172
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Ethics committee country [1] 298199 0
Australia
Date submitted for ethics approval [1] 298199 0
23/11/2016
Approval date [1] 298199 0
23/06/2017
Ethics approval number [1] 298199 0
HREC/17/QRBW/54

Summary
Brief summary
REPAIR is a study investigating the role of regional anaesthesia (RA) for reducing pain experienced during dressing change for patients who require split skin grafting after suffering burn injuries to the upper limbs.

There are approximately 50,000 burn related hospital admissions per annum in Australia at an economic cost of $230m. This patient cohort may experience neuropathic or nerve pain that is notoriously difficult to treat. This trial will compare current pain practice with the use of RA in patients who have suffered burns and require dressing changes on the ward post split-skin grafting procedures. This study aims to redefine the way clinicians treat burn pain, and to lay the ground work for further investigation into RA and optimization of care for patients with burn injuries.

Aim:
To assess the effectiveness of regional anaesthesia as an intervention for burn pain associated with change of dressings and removal of staples after split skin grafting procedures to the upper limbs.

Objectives:
1. To compare and contrast the outcomes of two patient cohorts receiving removal of staples and dressing change after upper limb split skin grafting including:
a. Control group receiving standard opioid intervention as per treating team.
b. Cohort receiving a single dose nerve block to upper limb grafting site.

Methods
Prospective, randomised clinical trial.

Following institutional ethical approval, 20 participants will be sourced from the Royal Brisbane and Women’s Hospital acute in-patient burns unit. Written, informed consent will be obtained before patients are enrolled in the study. Patients will only be enrolled if they meet the inclusion criteria, and consent to the study. This study population of 20 patients will be divided into two groups (10 patients in each) with a control and interventional group.

Once informed consent is obtained, participants will be randomised into two groups using a random number generator and sealed envelopes.Group one (I) will receive standard opioid intervention as per their treating team. Group two (II) will receive will receive standard opioid intervention with the addition of an ultrasound guided single-shot axillary brachial plexus block using 0.375% ropivacaine of 20-30mls. All patients will be charted post-procedural pain relief and antiemetics as per their treating team, and the addition of regional blockade will not affect availability of pain relief in any way.

All blocks will take place in the designated anaesthetic block room prior to dressing change procedure. Blocks will be placed by qualified and experienced anaesthetic fellows and consultants under direct ultrasound guidance, employing aseptic technique, and according to standard practice.The efficacy of the block will then be judged based on the three point sensory and function motor scale. Skin sensation will be assessed, along with functional capacity.

Patients will be followed up by a study member and data will be collected pertaining to numeric pain scores and opioid requirements daily for 7 days post-procedure or until discharge from hospital if it occurs sooner.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 76306 0
Ms Cienwen Town
Address 76306 0
Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital. Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 76306 0
Australia
Phone 76306 0
+61 451438809
Fax 76306 0
Email 76306 0
[email protected]
Contact person for public queries
Name 76307 0
Ms Cienwen Town
Address 76307 0
Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital. Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 76307 0
Australia
Phone 76307 0
+61 451438809
Fax 76307 0
Email 76307 0
[email protected]
Contact person for scientific queries
Name 76308 0
Ms Cienwen Town
Address 76308 0
Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital. Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 76308 0
Australia
Phone 76308 0
+61 451438809
Fax 76308 0
Email 76308 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
complete data analysis in the form of publication will be made available as a collective.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo nil

Documents added automatically
No additional documents have been identified.