Analgesic Effect of an Obturator Nerve Block Combined With a Femoral Nerve Block Compared With Femoral Nerve Block Alone in Patients With Hip Fracture
试验速览
- 阶段
- 4 期
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
研究概览
简要总结
A higher number than expected of patients with hip fracture have only insufficient analgesic effect of a femoral nerve block, which is the nerve block commonly used for this group of patients. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve.
The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
详细描述
A higher number than expected of all patients with hip fracture have only insufficient analgesic effect of a femoral nerve block. One of the possible causes of this failure to provide analgesia from a single nerve block could be the that other nerves are involved in transmitting the pain signal. One of the nerves that is believed to give off branches to the hip is the obturator nerve. Earlier it was believed that the so called '3-in-1-block' or the iliac fascia compartment block would anesthetize also the obturator nerve, and these two nerve blocks have been uses extensively in the emergency ward for preoperative analgesia. Today that is not believed to be true and consequently is the part of the obturator nerve in patients with hip fracture unknown.
With ultrasound it is possible to make a selective proximal nerve block of the obturator nerve before it branches into an anterior and a posterior branch. A selective nerve block of the obturator nerve to access its effect in patients with hip fracture has to our knowledge never been done.
The aim of this trial is to test the analgesic effect of a femoral nerve block i combination with an obturator nerve block compared to femoral nerve block alone in a randomized and placebo controlled design.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical suspicion of hip fracture
- •Age ≥ 55 years
- •Mentally capable of comprehending and using verbal pain score
- •Mentally capable of differentiating between pain from the fractured hip and pain from other locations
- •Mentally capable of understanding the given information
- •Arrival in the emergency room at times when one of the doctors who do the nerve blocks for this investigation are on call
- •Verbal numeric pain scale score (NRS 0-10) > 5 with a dynamic test OR NRS > 3 at rest
- •Patients informed consent
排除标准
- •Hip fracture not confirmed by x-ray
- •Weight < 40 kg
- •Patient has previously been included in this trial
- •If the patient wishes to be excluded
- •Allergy to local anesthetics or adrenocortical hormone
- •Visible infection in the area of the point of needle injection
研究组 & 干预措施
Bupivacaine
Obturator nerve block
干预措施: Bupivacaine (Drug)
Saline
Saline is injected as a placebo
干预措施: Saline (Drug)
结局指标
主要结局
Success rate of successful analgesia, measured with numeric rating scale(NRS) 0-10 with 0=no pain and 10=worst pain. Successful analgesia = NRS<4 at rest and NRS <6 with passive movement of the fractured leg.
时间窗: 30 minutes
Success rate of successful analgesia compared between the groups
次要结局
- Localization of the worst pain before block(0 minutes)
- Localization of the worst pain after block(30 minutes)
- Discomfort during nerve block procedures (score 0-10, 0=no discomfort)(5 minutes)
- Frequency of ultrasound visualization of obturator injection site(5 minutes)
- Total morphine equivalent dose of opioid/time in the first 10 hours after nerve block(10 hours)
- Course in pain reduction(30 minutes)
- Time to sufficient analgesia(30 minutes)
- Frequency of anesthesia in the skin area of the saphenous nerve(30 minutes)
- Time spend on obturator nerve block(5 minutes)
- Total morphine equivalent dose of opioid from the time of nerve block to operation(Approximately 24 hours in average)
- Total morphine equivalent dose of opioid/time from the time of nerve block to operation(Approximately 24 hours in average)
- Median pain score (NRS 0-10)(30 minutes)
- Median change in pain score (NRS 0-10)(30 minutes)
- Frequency of anesthesia in the skin area of the anterior cutaneous branches of the femoral nerve(30 minutes)
- Frequency of ultrasound visualization of femoral nerve(5 minutes)
- Time spend on femoral nerve block(5 minutes)
- Satisfaction (0-10, 0= very unsatisfactory)(30 minutes)
- Total morphine equivalent dose of opioid in the first 10 hours after nerve block(10 hours)