None listed
Conditions
Brief summary
Lung transplantation aims to extend the lifespan and improve the quality of life for people living with end-stage lung disease. Most lung transplants now involve thoracotomy incisions between two ribs and spreading of the ribs to allow for removal, insertion, and attachment of lungs. Thoracotomies can be very painful for weeks and in many patients can result in longer term nerve pain that can have significant negative impacts on quality of life. Two novel techniques to manage pain for lung transplant patients have been introduced to supplement morphine-type pain medications: a catheter that delivers local anaesthetic to the area and cryotherapy to temporarily freeze and numb the nerves in the area. This study aims to assess if either technique leads to a shorter time in intensive care, better recovery, and better pain relief from the incision in the short term and potential nerve pain in the longer term. It is hypothesised that there will be no differences between these two techniques. The study will also be looking for side effects with each technique.
Interventions
Cryoanalgesia:
This procedure uses the cryoSPHERE (Atricure, USA) which is in routine use within St Vincent’s Public Hospital and involves freezing the intercostal nerves in the - 50 to -70°C range from within the surgical wound. Axons within the intercostal nerve that send pain signals are destroyed distal to the cryoablation site. The tubule structures (epineurium, perineurium, and endoneurium) of the nerve remain intact allowing the axons to regenerate and nerve function to resume over the c
Cryoanalgesia: This procedure uses the cryoSPHERE (Atricure, USA) which is in routine use within St Vincent’s Public Hospital and involves freezing the intercostal nerves in the - 50 to -70°C range from within the surgical wound. Axons within the intercostal nerve that send pain signals are destroyed distal to the cryoablation site. The tubule structures (epineurium, perineurium, and endoneurium) of the nerve remain intact allowing the axons to regenerate and nerve function to resume over the course of roughly 1-3 months. Cryoablation will be performed by a member of the surgical team prior to wound closure. The intercostal nerve at the level of the anterior thoracotomy incision (T4 – T5) as well as one level superior and two levels inferior will be performed. Each level takes 120 seconds to ablate so the time involved is approximately 8 minutes for a unilateral and 16 minutes for a bilateral transplant. Administration and duration of cryoanalgesia will be documented in participants' medical records.
Sponsors
St Vincent’s Public Hospital Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Aged 18 years or older Undergoing a single or double lung transplant at St Vincent’s Public Hospital Sydney Able and willing to provide written informed consent, including sufficient English skills
Exclusion criteria
Allergy to local anaesthesia Undergoing a joint heart and lung transplant Use of clamshell incision
Outcome results
None listed