Evaluating the Efficacy of the Sub-psoas Fascial Plane Block for Post-operative Analgesia Following Hemiarthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Opioid Consumption
研究概览
简要总结
The study aims to examine the efficacy and safety of an ultrasound-guided regional anaesthetic technique intended to provide pain relief following hip surgery. It involves targeting a layer of tissue known as the psoas fascia, where the nerves of the lumbar plexus, supplying the lower limb, are located. There are many well-established ultrasound-guided techniques that target similar anatomical planes and structures, such as the psoas compartment block and quadratus lumborum plane block, which are widely used in clinical practice. This is not a new technique but rather a new approach to a well-established and utilized technique (the psoas compartment block). Early remobilisation plays a key role in the recovery of post-operative patients, helping to reduce the incidence of pneumonia, deep vein thrombosis, and delirium. By reducing motor weakness while still providing adequate pain relief and minimizing the use of strong painkillers such as morphine, it will help to reduce the risk of falls and length of hospital stay. An initial case series in GUH has previously followed a small cohort of patients who, following informed consent, underwent the subpsoas fascia plane (SPF) block vs. suprainguinal fascia iliaca block as part of their multimodal pain relief following surgery. It was found that in this group there was a reduction in postoperative pain scores, decreased use of strong painkillers, and earlier time to remobilisation.
详细描述
Background:
Hip fracture surgery is one of the commonest orthopaedic operations performed in the Republic of Ireland, and is associated with significant patient morbidity, mortality and health care costs. The National Irish Hip Fracture Report recorded 1,950 hip fractures in 2013, 71% were female and the highest proportions were in the 80-89 age group. It has been estimated that the overall prevalence of hip fractures is projected to increase in line with increasing elderly population and projected demographic changes.
Early remobilization has become a key integral component of the optimal post-surgical management of hip fractures. Based on the National Institute for Health and Care Excellence (NICE) guidance, the National Hip Fracture UK Database has adopted patient remobilisation on the day of or day after surgery as a key performance indicator. Early mobilisation has been shown to reduce the risk of in-hospital mortality following hip fracture and to increase the likelihood of discharge from hospital. In 2018, 20% of patients failed to achieve the early remobilisation target, due to pain and/or hypotension, factors which might have been anticipated by clear perioperative protocols and closer working between surgery and anaesthetic colleagues.
Current AAGBI guidelines describe core principles of the peri-operative management of people with hip fracture, with one of their aims recommending a peripheral nerve block immediately prior to operative fixation of a hip fracture (in the Emergency Department and at the time of surgery, provided six hours have passed between blocks). There are two peripheral nerve blocks commonly used in the perioperative setting of hip fracture repair, namely femoral or fascia iliaca block. Both techniques have been proven to be safe and efficacious, however, these peripheral nerve blocks have been associated with some residual muscle weakness and increased falls risk which further hampens the ability of a patient to remobilize post-operatively. There is a clinical need to establish a safe, reliable regional anaesthetic technique that will still offer long-acting opioid sparing analgesia, yet minimise the associated motor blockade in order to improve and facilitate remobilization. By also potentially interrupting the sympathetically mediated pain in the lower limb following hip surgery through the blockade of this lumbar sympathetic plexus, it may provide an avenue to produce significant analgesia without causing somatic sensory deficits (e.g. residual motor weakness), thereby facilitating early remobilisation and enhanced recovery. This is not a new technique, rather it is a new approach to a very well established and utilized technique (the psoas compartment block) which has been shown to be very effective, this approach is expected to be as efficacious and potentially safer than previous approaches as it avoids the nerve roots. In terms of the side effect profile of this novel approach to the PCB - there are no new expected side effects above the standard previously explained effects that can occur with any regional technique (for example, haematoma/ LAST / Neuropraxia). This approach would theoretically be associated with a lower side effect profile than previous landmark or current ultrasound-guided PCB technique as it avoids the risk profile of traversing the psoas muscle body and near the exit of the lumbar plexus nerve roots.
This study aims to follow up on the inital case series discussed above to evaluate the efficacy of the SPF block for post op analgesia in patients undergoing hemiarthroplasty surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals undergoing orthopaedic surgery at the hip joint in University College Hospital, Galway.
- •Individuals over 18 years of age.
- •Individuals treated with psoas muscle sympathetic nerve blocks as part of multi-modal analgesic management.
- •Individuals with the capacity to make an informed decision regarding study participation.
- •Patients that provide written and verbal informed consent.
- •Patients whom have not received a fascia iliacus block in the emergency department prior to their surgery.
排除标准
- •To be eligible, a patient must have none of these exclusion criteria
- •Individuals unable to provide informed consent.
- •Individuals < 18 years of age.
- •Individuals with an intellectual disability (IQ < 70), cognitive impairment, delirium or with dementia.
- •Allergy to the local anaesthesia block components.
- •Patients with absolute or relative contraindication to peripheral nerve blocks.
- •Coagulopathy (Prothrombin time/International Normalized Ratio of more than 1.50, Activated Partial Thromboplastin Time of more than 60 seconds).
- •Cases judged to be inappropriate by the chief investigator.
- •Patients whom have received a fascia iliacus block in the emergency department prior to their surgery
结局指标
主要结局
Opioid Consumption
时间窗: 48 hours
Intraoperative and Postoperative Opioid Requirements Quantification
Pain Score
时间窗: 48 hours
Pain score - NRS - Numerical Rating Score requires the patient to rate their pain on a defined scale. 0-10 where 0 is no pain and 10 is the worst pain imaginable
Evaluation of Efficacy of SPF Block - Quality of Recovery
时间窗: 48 hours
Quality of Recovery 15 (QoR15) Score a patient-reported outcome measurement measuring QoR after surgery and anesthesia. minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).
次要结局
- Time to remobilisation post-operatively(48hrs)
研究者
Orla Murphy
Dr Orla Murphy, Specialist Registrar Anaesthesia
University College Hospital Galway
