Analgesic Duration af a Preoperative Single-shot Femoral Nerve Block With Bupivacaine and Adjuvant Dexamethasone in Patients With Hip Fracture
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Frequency of analgesia at the time of operation or at 20 hours
研究概览
简要总结
Prolongation of the analgesic effect of a femoral nerve block from the present 15 hours to 24 hours in patients with hip fracture would have a major impact in order to provide better preoperative analgesia for this group.
In other trials concerning other nerves then the femoral nerve the addition of Dexamethasone to the local anesthetics doubled the analgesic duration. No studies has investigated the effect of the addition of Dexamethasone to the femoral nerve block in patients with hip fracture.
The aim of our study is to investigate if more patients with hip fracture experience lasting preoperative analgesia until the time of operation or 20 hours after a femoral nerve block with the addition of Dexamethasone compared to the same nerve block done without Dexamethasone.
详细描述
Patients with hip fractures are most often old, have multiple comorbidities and suffer severe pain.
Femoral nerve block as a means of preoperative analgesia for these patients has proven effective in multiple trials for the majority of the patients. Still some issues remains to be investigated in order to optimize the preoperative analgesia for this group.
One of the issues that reduces the feasibility of the femoral nerve block is the relatively shorter analgesic duration of the nerve block compared to the often longer time from the hospital admission to the actual operation. From the literature and our own experience the mean analgesic duration of a femoral nerve block approximates 15 hours.
Many studies have shown a prolonged analgesic duration of different nerve blocks when Dexamethasone was added to the local anesthetics. Some studies show a 100 percent increase in duration.
To our knowledge no studies have been published regarding prolongation of the analgesic effect of the femoral nerve block with Dexamethasone, and also none regarding the group of patients with hip fracture.
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 pain score (0-10) ≥ 7 with passive leg raise of the fractured leg at the time of inclusion
- •Patients informed consent
排除标准
- •Hip fracture not confirmed by x-ray
- •Weight < 40 kg
- •Verbal pain score > 3, 30 minutes after the nerve block
- •Verbal pain score > 5 with passive leg raise, 30 minutes after the nerve block
- •Patient has previously been included in this trial
- •Ongoing pre traumatic treatment with parenteral or intravenous adrenocortical hormone
- •Verbal pain score > 3 from other locations than the fractured hip
- •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
- •Acute inability to comprehend and use verbal pain score
研究组 & 干预措施
Saline
Bupivacaine with adrenaline with 2 ml. of Saline added
干预措施: Saline (Drug)
Dexamethasone
Bupivacaine with adrenaline with 2 ml. of Dexamethasone added
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Frequency of analgesia at the time of operation or at 20 hours
时间窗: Until the start of the operation or at 20 hours, average 18 hours
Frequency of analgesia at the time of operation or at 20 hours in patients with hip fracture after femoral nerve block with Dexamethasone added to Bupivacaine compared to plain Bupivacaine
次要结局
- Frequency of analgesia at the time of operation or at 24 hours(Until the start of the operation or at 24 hours, average 22 hours)
- Nerve visualization(Just before injection, which is within an expected average of 10 minutes after inclusion)
- Time to analgesic effect measured while doing passive leg raise(30 minutes)
- Frequency of patients without sufficient analgesia(30 minutes)
- Time to wish for opioid analgesia(Until the start of the operation or at 24 hours, average 22 hours)
- Frequency of analgesia at the time of operation or at 22 hours(Until the start of the operation or at 22 hours, average 20 hours)
- Frequency of satisfactory analgesia(Until the start of the operation or at 20 hours, average 18 hours)
- Use of opioid analgesia until 20 hours(Until the start of the operation or at 20 hours, average 18 hours)
- Use of opioid analgesia until 24 hours(Until the start of the operation or at 24 hours, average 22 hours)
- Time to analgesic effect with patient at rest(30 minutes)
- Frequency of insufficient analgesia(30 minutes)
- Skin sensation in area of the anterior cutaneous branches of the femoral nerve(30 minutes)
- Skin sensation in saphenous area(30 minutes)
- Use of opioid analgesia until 22 hours(Until the start of the operation or at 22 hours, average 20 hours)
- Frequency of absent analgesia(30 minutes)
- Sufficient analgesia Dexamethasone vs. plain(30 minutes)