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
ACTRN12617001053314
Ethics application status
Approved
Date submitted
11/07/2017
Date registered
19/07/2017
Date last updated
26/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound-Guided Regional Anaesthesia In Patients Receiving Split-Skin Grafting For Various Burns With Donor Sites From The Upper Thigh: A Prospective Randomized Study
Scientific title
Ultrasound-Guided Regional Anaesthesia In Patients Receiving Split-Skin Grafting For Various Burns With Donor Sites From The Upper Thigh: A Prospective Randomized Study
Secondary ID [1] 292390 0
n/a
Universal Trial Number (UTN)
n/a
Trial acronym
RELIEVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Burn Pain 303956 0
Condition category
Condition code
Anaesthesiology 303311 303311 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 and surgeon local anaesthetic infiltration as per their treating team for the treatment of pain associated with split skin graft donor sites taken from the thigh for the treatment of burn related injuries. Group two (II) will receive an ultrasound guided single-shot fascia iliaca plane block (FIPB) of 0.375% ropivacaine of 20-30mls to provide donor site analgesia on the day of surgery.
The interventional group will receive their FIPB in the designated anaesthetic block room prior to general anaesthetic for split skin graft harvesting. 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 Fascia iliaca plane block provides effective pain relief for skin grafts from the proximal thigh by blocking the sensory function of the femoral nerve and the lateral femoral cutaneous nerve of the thigh. Patients will be connected to routine 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 may require sedation to relax them as required. The block will be administered as follows:
• The patient is positioned supine with the ultrasound machine placed on the opposite side so that the operator's line of sight, needle, and the screen is in a straight line. Local anaesthetic will be injected into the surrounding tissue to numb the area.
• The ultrasound probe is placed on the proximal thigh just below the inguinal ligament transverse to the anticipated lie of the femoral nerve, artery and vein.
• Two fascia layers should be identified – the fascia lata (superficially) and the deeper fascial iliaca (overlying the ilacus muscle and femoral nerve).
• Using an in-plane ultrasound guided technique the block 100mm 22g short bevel block needle is advanced through both fascial layers to lie just beneath the fascia iliaca and above the iliacus muscle lateral to the femoral nerve.
• Injection of the local anaesthetic solution is performed between the fascia and deeper muscle layer.

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.
Intervention code [1] 298564 0
Treatment: Other
Intervention code [2] 298595 0
Treatment: Drugs
Comparator / control treatment
Group one (I) will receive standard opioid administration and surgeon local anaesthetic infiltration as per their treating team for the treatment of pain associated with split skin graft donor sites taken from the thigh for the treatment of 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] 302695 0
The efficacy of regional anaesthesia will be judged based on the 10 point numeric pain scale.
Timepoint [1] 302695 0
Primary time point will include data collection during the immediate postoperative recovery phase- assessments are made every 10 minutes during the postoperative recovery phase as per recovery protocol requirements, Then daily for 7 days post commencement of intervention or until discharge if that occurs sooner.
Primary outcome [2] 302735 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] 302735 0
Primary time point will include data collection during the immediate postoperative recovery phase- assessments are made every 10 minutes during the postoperative recovery phase as per recovery protocol requirements, Then daily for 7 days post commencement of intervention or until discharge if that occurs sooner.
Secondary outcome [1] 336771 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] 336771 0
Assessment will take place 10 minutes, 20 minutes, and 30 minutes after the regional block has been placed and before the participants enters theatre.

Eligibility
Key inclusion criteria
- Patients aged >17 years
- General anaesthesia for burn procedures requiring split skin grafting
- Patients receiving donor skin from the upper thigh
- ASA 1-3
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 graft harvesting from areas other than the upper thigh
- History of local anaesthetic allergy
- Contraindication to regional anaesthesia
- Inability to give informed consent
- Significant anticoagulation/coagulopathy.

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
Recruiting
Date of first participant enrolment
Anticipated
7/08/2017
Actual
25/07/2017
Date of last participant enrolment
Anticipated
28/12/2018
Actual
Date of last data collection
Anticipated
28/12/2018
Actual
Sample size
Target
20
Accrual to date
11
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 8524 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 16618 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 296945 0
Hospital
Name [1] 296945 0
Department of Anaesthetics and Perioperative Medicine, Royal Brisbane and Womens Hospital
Country [1] 296945 0
Australia
Primary sponsor type
Individual
Name
Cienwen Town
Address
Department of Anaesthetics and Perioperative Medicine, Royal Brisbane and Womens Hospital.
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 295949 0
Individual
Name [1] 295949 0
James Johnson
Address [1] 295949 0
Department of Anaesthetics and Perioperative Medicine, Royal Brisbane and Womens Hospital.
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country [1] 295949 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298150 0
Royal Brisbane and Womens Hospital Human Research Ethics Committee EC00172
Ethics committee address [1] 298150 0
Royal Brisbane and Womens Hospital Human Research Ethics Committee EC00172
Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Ethics committee country [1] 298150 0
Australia
Date submitted for ethics approval [1] 298150 0
23/11/2016
Approval date [1] 298150 0
05/05/2017
Ethics approval number [1] 298150 0
HREC/17/QRBW/55

Summary
Brief summary
RELIEVE is a study investigating the role of regional anaesthesia (RA) for reducing pain for patients who require split skin grafting after suffering burn injuries.

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 split skin grafting. 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 treating pain resulting from anterior thigh split skin graft donor sites in patients undergoing burn injury treatment.

Objectives:
To compare and contrast the outcomes of two patient cohorts receiving split skin grafts for burn related injuries:
a. Control group receiving standard intervention for harvest of donor site skin from the anterior thigh as per treating team.
b. Cohort receiving a single dose fascia iliaca plane block (FIPB) (incorporating blockade of the femoral nerve and lateral femoral cutaneous nerve of the thigh).

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 administration and surgeon local anaesthetic infiltration as per their treating team. Group two (II) will receive an ultrasound guided single-shot fascia iliaca plane block (FIPB) of 0.375% ropivacaine of 20-30mls to provide donor site analgesia on the day of surgery.

All blocks will take place in the designated anaesthetic block room prior to general anaesthetic for split skin graft harvesting. 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 76146 0
Ms Cienwen Town
Address 76146 0
Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital. Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 76146 0
Australia
Phone 76146 0
+61 451438809
Fax 76146 0
Email 76146 0
[email protected]
Contact person for public queries
Name 76147 0
Ms Cienwen Town
Address 76147 0
Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital. Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 76147 0
Australia
Phone 76147 0
+61 451438809
Fax 76147 0
Email 76147 0
[email protected]
Contact person for scientific queries
Name 76148 0
Ms Cienwen Town
Address 76148 0
Department of Anaesthesia and Perioperative Medicine, Royal Brisbane and Women's Hospital. Butterfield St & Bowen Bridge Rd, Herston QLD 4029
Country 76148 0
Australia
Phone 76148 0
+61 451438809
Fax 76148 0
Email 76148 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
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4059Plain language summaryNo NIL

Documents added automatically
No additional documents have been identified.