None listed
Conditions
Brief summary
Surgery on chest, abdomen, pelvis and hip (torso) is commonly performed worldwide. Adequate pain relief is essential for smooth recovery and avoidance of complications after surgery. Commonly, strong painkillers containing morphine or morphine like drugs (opioids) are used to treat pain following surgery. Opioids have side-effects such as drowsiness, nausea and vomiting. Furthermore, opioids can impair respiratory function, resulting in reduced oxygen in the bloodstream. Opioids are also highly addictive, and it has become apparent that when patients use these drugs to treat pain following surgery, a proportion continue to take the drugs well beyond the period that they are required to do so because of pain. In other words, the use of opioids to treat acute pain following surgery is a potential pathway to persistent use of opioids and even addiction. In the United States, a leading cause of death is opioid overdose following a legal prescription. There are signs in Australia that similar events are occurring, for example our population are increasingly being prescribed stronger longer lasting opioids and there have also been an increase in opioid-related deaths. In this research, we will be examining whether a regional anaesthesia technique called erector spinae block is effective in both reducing pain and patients’ requirements for highly addictive opioids. Erector spinae block uses local anaesthetic to block the pain and therefore it should reduce the need for opioids, however, this is technique is new and therefore should be subject to rigorous scientific evaluation. The erector spinae block uses ultrasound to guide injection of local anaesthetic between the muscle layers of the back. The nerves that supply the chest, abdomen, pelvis and hip are located between these muscles. By numbing these nerves, this technique has the potential to reduce pain after surgery on the torso. This study is a placebo-controlled randomised controlled trial and involves patients being allocated into two groups. Each group has a different treatment, erector spinae block either with local anaesthetic (active treatment) or with saline (salt water mixture, placebo). A catheter (thin plastic tube) will be inserted into the plane and regular boluses will be given up to 24 hours after the operation, with solutions administered depending on the patient allocation group. To ensure the groups are similar, each patient is allocated to a group by chance (random) before surgery takes place. The patients have an equal chance of being allocated to either the treatment group or placebo group. We plan to recruit 80 patients into the study.The main outcomes to be measured are pain score, opioid use and other outcomes that are important to the patient. These include patient-rated quality of recovery and satisfaction 24 hours after the operation. We expect that patients who received erector spinae block will have reduced pain scores and improved quality of recovery.
Interventions
Continuous erector spinae block is the intervention. Erector spinae block is a new regional anaesthesia technique of the torso. This intervention will be delivered by an anaesthetist with extensive experience in ultrasound-guided regional anaesthesia techniques (> 100 procedures) and who has performed a minimum of 10 ultrasound-guided erector spinae blocks. All procedures will be performed or observed by researcher. A training video has been produced to assist in standardising the procedure (htt
Continuous erector spinae block is the intervention. Erector spinae block is a new regional anaesthesia technique of the torso. This intervention will be delivered by an anaesthetist with extensive experience in ultrasound-guided regional anaesthesia techniques (> 100 procedures) and who has performed a minimum of 10 ultrasound-guided erector spinae blocks. All procedures will be performed or observed by researcher. A training video has been produced to assist in standardising the procedure (https://www.dropbox.com/s/2iz4qz4e88zcv6p/Barrington_ErectorSpinaeBlock.mp4?dl=0). This intervention will be delivered 30 - 60 minutes preoperatively. The intervention involves injection of local anaesthetic, ropivacaine 0.5% (group L) or normal saline placebo (group P) in the plane between the erector spinae muscle and the thoracic transverse process. The needle trajectory is guided by ultrasound imaging with the transducer in longitudinal orientation so that the transverse processes are imaged in the sagittal plane and the needle is in-plane. The initial injection (0.35 mL/kg) will be followed by a postoperative infusion regimen of either local anaesthetic, ropivacaine 0.2% ( group L) or normal saline placebo (group P). This regimen will comprise every 4 hours a bolus: 15 mL if weight < 60 kg; 20 mL if weight > or equal t0 60 kg.
Sponsors
Michael Barrington
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
Patients scheduled for the following surgery: video-assisted thoracoscopy, thoracotomy, mastectomy with and without reconstruction, axillary dissection, chest wall resection and/or reconstruction, upper abdominal laparoscopic surgery, ventral hernia repair and major lumbar/hip surgery. These surgical types are on the torso where erector spinae block is indicated based on published case reports and reported anatomical distribution of sensory blockade.
Exclusion criteria
Exclusions will comprise contraindications to the erector spinae block procedure (1. known hypersensitivity to ropivacaine or to any amide local anaesthetic; and 2. Local infection or tumour involvement at or close to the injection site), existing neuropathic pain or neurologic disorder affecting the torso, pregnancy, substance abuse; and impaired ability to complete questionnaires, communicate with the investigators or hospital staff.
Outcome results
None listed