CompletedPhase 1ACTRN12617001054303

Ultrasound-Guided regional Anaesthesia in Patients receiving Dressing Change After split-Skin grafting for Upper Limb burn Injuries: A Prospective Randomized Study


Sponsor

Cienwen Town

Enrollment

20 participants

Start Date

Aug 28, 2018

Study Type

Interventional

Conditions

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. 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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria4

  • Patients aged >17 years
  • Split Skin Grafting to their upper limbs
  • ASA 1-3
  • Patients remaining in hospital until change of dressing

Exclusion Criteria8

  • Patients with burns >15%
  • 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

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Interventions

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 i

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.


Locations(1)

Royal Brisbane & Womens Hospital - Herston

QLD, Australia

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ACTRN12617001054303