None listed
Conditions
Brief summary
We propose a trial to assess if intravenous (into the bloodstream via a vein) Lignocaine infusion helps to reduce donor site pain in patients undergoing split skin grafting (SSG) following major burns. The pain caused by a burns injury can be difficult to manage and often needs high doses of strong pain killing medications. Patients often report that the pain from the skin graft donor site can be as severe as the pain from the burn itself. The pain from the donor site is often poorly responsive to strong painkillers such as morphine. Lignocaine is commonly used for pain that is generated by damaged nerves (neuropathic pain). There is evidence to support use of Lignocaine to reduce the pain caused by other burns procedures such as dressing changes. There is currently no evidence regarding the use of Lignocaine for pain that is specific to the donor site. This study will help to guide evidence based practice regarding Lignocaine infusions for donor site pain. We will randomly assign all patients admitted under the Burns team at The Alfred who are older than 18 years, who have a burn affecting over 10% of their body surface area and who have the capacity to record pain scores and consent, to one of two groups; Group one will receive standard care plus a bolus and intravenous infusion of Lignocaine Group two will receive standard care plus a bolus and intravenous infusion of Saline (Saline has no effect on pain and acts as a placebo). Neither the patients nor the medical teams will know which patients are in which group. We will record information about the pain the patient is experiencing and also the pain medications they are using before and after the surgery. The infusions will run for 24 hours. We will continue to follow up the patients for 5 days after their surgery. All the patients will be reviewed by the acute pain team who will assess the patient’s pain and make adjustments to the other pain treatments the patients receive. We have a strict protocol for how the medications can be increased. Treating pain is the first priority and no patient will have pain that is uncontrolled as a result of the trial. We will collect two blood samples during the trial to assess the blood level of the trial drug Lignocaine. One will be taken whilst the patient is asleep during their surgery and the second will be taken when the infusion is stopped. The second sample will be taken with the usual post-operative blood tests to minimise extra blood tests. We will follow up the patients 6 months following their burns injury to ask them if they have any ongoing pain that is caused by their burns injury. If they answer yes we will ask them a brief questionnaire asking them about their pain and also collect a list of the medications they are taking for pain. All data collected as part of the trial will be de-identified at all stages and will be submitted for publication in a medical journal. Results of the trial will be available if the patients request it through the burns team, although we will not be able to release any individual data.
Interventions
At the time of surgery for first Split skin graft treatment for burn injury.
Group 1 will receive standard therapy (opioids and anti-neuropathic agents) with addition of intravenous Lignocaine bolus (1.5mg/kg) and intravenous Lignocaine infusion (1.25mg/kg/hr) started pre-incision and continued for 24hrs,
Group 2 will receive standard therapy plus intravenous 0.9% saline bolus and intravenous 0.9% saline infusion continued for 24 hrs.
Standard therapy as follows unless medically contraindicated:
At the time of surgery for first Split skin graft treatment for burn injury. Group 1 will receive standard therapy (opioids and anti-neuropathic agents) with addition of intravenous Lignocaine bolus (1.5mg/kg) and intravenous Lignocaine infusion (1.25mg/kg/hr) started pre-incision and continued for 24hrs, Group 2 will receive standard therapy plus intravenous 0.9% saline bolus and intravenous 0.9% saline infusion continued for 24 hrs. Standard therapy as follows unless medically contraindicated: Paracetamol 1gram Four times a day Celecoxib 100mg twice a day Opioids Slow release(MS Contin/Oxycontin/Targin) Given orally twice a day Titrated to effect Opioids Immediate release (Endone/Ordine) Given orally as required titrated to effect Pregabalin Given orally twice a day. Titrated from 50mg twice a day up to maximum 300mg twice a day Titrated to effect
Sponsors
The Alfred
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Greater than or equal to 7% TBSA (total burn surface area) 1st SSG (split skin graft) surgery Age 18 years or older Capacity to record pain scores and consent
Exclusion criteria
Patients already receiving Lignocaine infusion or oral mexilatine Allergies to amide local anesthetics Cardiac arrhythmia's such as 2nd/3rd degree heart block, Wolf Parkinson White Heart failure Hepatic failure Hyperkalaemia Patient refusal
Outcome results
None listed