Preoperative Use of Peripheral Nerve Blocks in Elderly Patients With Hip Fractures: a Factorial Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Pain relief
研究概览
简要总结
The goal of this clinical trial is to explore the effects of different peripheral nerve blocks in older adults with hip fractures. It will also explore the safety of preoperative administration of peripheral nerve blocks. The main questions this trial aims to answer are:
- which peripheral nerve block is the best regarding analgesia
- which peripheral nerve block eases positioning and decrease time necessary for applying spinal anesthesia?
- which peripheral nerve block is associated with reduced intake of analgesics, both oral and intravenous?
- which peripheral nerve block lasts long enough but does not interfere with the start of physical therapy?
- what medical problems do respondents have during their hospitalization, after administration of peripheral nerve blocks, spinal anesthesia and surgery?
- what medical problems arise as a consequence of their complex medical history? Researchers will compare respondents who receive peripheral nerve blocks to those who do not. Those who do not receive blocks will be given fentanyl preoperatively, which was until recently standard at our institution.
All respondents will, in addition to obligatory intraoperative monitoring,:
- be thoroughly examined by anesthesiologists before surgery
- be closely monitored after surgery, until their hospital discharge.
详细描述
The aging of the population is a global trend. In the elderly population, hip fractures are among the leading reasons for hospitalization and in most cases require surgical treatment. When we talk about hip fractures, we actually mean fractures of the proximal femur, which are classified according to the AO school as extracapsular (trochanteric region) and intracapsular (femoral neck area). Articular fractures (femoral head area) are very rare and not the subject of this study.
Patients with hip fractures, in addition to their advanced age, have numerous comorbidities. That is why mortality rate is high, up to 36% within a year of surgery, and perioperative care of such patients is a challenge for everyone involved in their treatment, especially surgeons and anesthesiologists. Despite this, to this date our institution has no protocol that would ensure standardization of the care in perioperative period, although this is recommended by professional societies. That is why we designed this study, in which we emphasize use of regional anesthesia in elderly patients.
The goal of this clinical trial is to promote usage of peripheral nerve blocks. Based on our clinical experience, peripheral nerve blocks act as aids for spinal anesthesia positioning and are a crucial part of peri-operative multimodal analgesia protocols in elderly patients scheduled for hip fracture surgery.
We believe that our results will show that peripheral nerve blocks decrease pain and amount of analgesics used in perioperative period, per mouth as well as intravenously. However, in order to include their use into standard operating protocols, we need to determine which block is the best for our group of patients, considering different types of fractures and types of surgeries. We also need to determine which block provides the best analgesia, both for positioning for spinal anesthesia and postoperatively, which block lasts the longest, while not interfering with the start of physical therapy and not prolonging hospital stay.
Primary outcome of this research is to determine pain. It will be determined using visual analogue scale, at rest and dynamically, while leg is being passively raised for 15˚.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Respondents will not know to which group they have been randomized, nor will the surgeons, anesthesiology residents, nor nurses on the ward. Anesthesiologists will be familiar with all the items and will therefore be considered as the study supervisors.
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •both sexes
- •60 years old and older
- •diagnosed with a hip fracture resulting from low-energy trauma
- •scheduled surgery.
排除标准
- •polytraumatized patients
- •dementia and acute psychosis patients
- •patients for whom spinal anesthesia is contraindicated
- •patients with severe renal failure
- •patients for whom intravenous administration of tranexamic acid is contraindicated
- •patients with proven allergy and contraindications to dexamethasone, non-steroidal anti-rheumatic drugs, opioid analgesics, magnesium sulfate.
研究组 & 干预措施
Extracapsular hip fracture FEMORAL BLOCK
Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve blocks and spinal anesthesia are administered for osteosinthesis of hip fracture.
干预措施: FN and LFCN peripheral nerve blocks with spinal anesthesia (Procedure)
Intracapsular hip fracture FEMORAL BLOCK
Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture.
干预措施: FN and LFCN peripheral nerve blocks with spinal anesthesia (Procedure)
Intracapsular hip fracture PENG BLOCK
Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture.
干预措施: PENG and LFCN peripheral nerve blocks with spinal anesthesia (Procedure)
Intracapsular hip fracture FASCIA ILIACA BLOCK
Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for partial endoprothesis of hip fracture.
干预措施: FIC peripheral nerve block with spinal anesthesia (Procedure)
Intracapsular hip fracture FENTANYL
Patients with intracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Fentanyl intravenously and spinal anesthesia are administered for partial endoprothesis of hip fracture.
干预措施: Fentanyl (IV) with spinal anesthesia (Procedure)
Extracapsular hip fracture PENG BLOCK
Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve blocks and spinal anesthesia are administered for osteosinthesis of hip fracture.
干预措施: PENG and LFCN peripheral nerve blocks with spinal anesthesia (Procedure)
Extracapsular hip fracture FASCIA ILIACA BLOCK
Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Peripheral nerve block and spinal anesthesia are administered for osteosinthesis of hip fracture.
干预措施: FIC peripheral nerve block with spinal anesthesia (Procedure)
Extracapsular hip fracture FENTANYL
Patients with extracapsular hip fracture. The fracture pattern is verified with a native X-ray image of the broken hip in 2 projections. Fentanyl intravenously and spinal anesthesia are administered for osteosinthesis of hip fracture.
干预措施: Fentanyl (IV) with spinal anesthesia (Procedure)
结局指标
主要结局
Pain relief
时间窗: 20 minutes after application of the local anesthetic
The primary outcome measures of this research is pain relief after the administration of peripheral nerve block. Pain will be measured using VAS scale, as a part of one of EQ-5D-5L, at rest and during passive 15˚ leg rising. VAS is the most commonly used scale for pain measurement. VAS ratings (100-mm) of 0 to 4 mm will be considered as no pain; 5 to 44 mm as mild pain; 45 to 74 mm as moderate pain and 75 - 100 mm as severe pain. Cut off values for VAS vary depending on the context and the population. However, 33% decrease in pain is a reasonable standard for determining that a treatment provides meaningful relief.
次要结局
- Health Outcome(before application of the block, 20 minutes after application of the block, 5 minutes after application of spinal anesthesia, 2 hours after the operation (upon leaving the recovery room), 6 hours, 24 hours and 48 hours after the operation.)
- Time for the performance of spinal anesthesia in a sitting position(Before surgery)
- Rescue analgesics(After surgery, up to 48 hours)
- Time to the start of physical therapy(After surgery, up to 48 hours)
- Postoperative nausea(After surgery, up to 48 hours)
- Anxiety(After surgery, up to 48 hours)
- Time for the performance of peripheral nerve block(Before surgery.)
- Duration of peripheral nerve blocks(20 minutes after the block and 6 hours, 24 hours and 48 hours post surgery)
- Development of complications(From the admission, until hospital discharge.)
- Quality of recovery(Before and 24 hours after the surgery)
研究者
Ana Saric Jadrijev
MD, Anaesthesiology, Reanimatology and Intensive Medicine Specialist, Principal Investigator
University Hospital of Split