MORphine Use in the Fascia Iliaca Compartment Block With UltraSound
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Mean morphine consumption in milligrams per hour with PCA pump, extracted from PCA-pump memory (mg / hour).
研究概览
简要总结
Appropriate management of analgesia for proximal femoral fractures is a common problem in the emergency department (ED). Side effects from morphine usage such as nausea, vomiting, respiratory depression, sedation, and obstipation are especially pronounced in elderly. Fascia Iliaca Compartment Block (FICB) holds promise as a simple and safe, and effective alternative method to reduce pain. Local anaesthetic injected in the anatomic space underlying the fascia iliaca, spreads to block the nerves traversing it. This regional anaesthesia includes the femoral nerve. Previous studies in the ED showed promise but lacked blinding, involved low numbers of subjects, or did not use ultrasound localisation of the injection site. The latter is becoming common practice. In this randomised placebo controlled trial the FICB with ultrasound localisation of injection of levobupivacaïne will be compared to the FICB with placebo. It aims to prove that less morphine is used in the intervention group. Other research parameters are pain scores and minor adverse events related to morphine use.
详细描述
Proximal femoral fractures are common in the ED. A major challenge in such subjects is pain management. Suboptimal pain control is associated with stress, a prolonged hospital stay and delirium. Pain or fear of pain can limit early mobilisation, an important goal in treatment. Therefore early pain management is essential. Standard analgesic care consists of acetaminophen, opiates and/or Non-steroidal anti-inflammatory drugs (NSAID's). Opiates can cause respiratory depression, constipation, drowsiness, nausea and vomiting. Especially elderly patients are at risk for these side effects Regional nerve blocks are increasingly being adopted as an alternative pain management to systemic analgesia in the ED. One of such is the Fascia Iliaca Compartment Block (FICB). This is safe and simple to perform. Results from studies, despite lacking ultrasound guidance are promising. No permanent disability resulted from the few minor complications that have been reported. These include bladder perforation, pneumoretroperitoneum and neuropathy of the femoral nerve. Furthermore no additional treatment was necessary. Ultrasound prevents occurrence of such complications.
The studies that have compared this specific block to standard analgesia have shown that regional anaesthesia may be superior. However these studies have low inclusion numbers and lack of randomisation and/or blinding.. Literature up until now has used the numerical rating scale (NRS) as a primary outcome. Although the NRS is a very trustworthy method of measuring pain, the score is a subjective outcome Morphine consumption on the other hand is more objective.
The FICB involves the anatomic space situated at the level of the groin in which important nerves that supply the hip joint lie. Anteriorly the space is covered by the iliac fascia. It is therefore known as the fascia iliaca compartment. By introducing a large volume of local anaesthetic solutions, the femoral, lateral femoral cutaneous and to a lesser extent the obturator nerve are anesthetized. Solutions can spread easily within the compartment. Therefore a safe position injection site can be chosen, minimizing the risk of intravascular injection and nerve damage. The classic position for injection is about 3 centimetres lateral from the femoral nerve. In the original FICB the injection site is determined by using landmarks. The fascia iliaca compartment is then approached by introducing a blunt needle, which enables the physician to feel a 'pop' twice. The first pop is felt when the fascia lata is pierced, the second when the fascia iliaca is passed.
Most ED's nowadays have access to ultrasound. When used for FICB placement, the local anaesthetic solution is visualized as it is introduced into the space. Therefore a higher chance of successful placement of agent and a lower risk of complications can be expected. So far no large double blind randomised placebo controlled trials have evaluated morphine use in ultrasound guided placement of local anaesthetic agents with FICB in the ED. This study is designed as such. Total morphine use will be taken as the primary outcome, administered in the form of patient controlled analgesia (PCA).
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)
盲法说明
Syringes with either placebo or levobupivacaïne will be prepared under aseptic conditions and blinded by the hospital pharmacy. A supply of at least six syringe packs will be kept in the emergency department. Each pack will contain three different doses of either levobupivacain or placebo, of which one will be used according to the weight of the patient. When medication is used, the nurse, physician or researcher will inform the pharmacy, so new medication can be prepared. The hospital pharmacy will keep track of randomisation and register the allocation to either treatment or placebo. Allocation will remain blinded until all patients are included and all data is included.
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
- •Patient diagnosed with a proximal femoral fracture (femoral neck, trochanteric and sub trochanteric femoral fracture) upon arrival at the ED.
排除标准
- •No informed consent patient
- •Skin infection at injection site(s)
- •Morphine allergy
- •Levobupivacaïne allergy
- •Operation within an hour after admission
- •Inability to understand and quantify pain on a NRS
- •History of dementia
- •Neurological deficit of fractured leg upon arrival at the ED
- •Trauma with multiple fractures (more than 1)
- •Risk of compartment syndrome of ipsilateral lower leg
- •Proximal femoral fracture with other definitive treatment than operation
- •Transfer to another hospital
- •Actual morphine use
- •Distracting pain in other location than hip
- •No physician/nurse available for procedure.
- •Saturation < 90%
- •Previously unreported hypotension (systolic blood pressure < 100 mmHg)
- •ASA IV or higher
研究组 & 干预措施
Levobupivacaïne
Fascia Iliaca Compartment Block with Levobupivacaine Hydrochloride (weight based dosage and volume)
Ideal Body Weight : Levobupivacaïne dose (mg) : Dose/kilogram (mg/kg) : Total volume (ml)
- [<64 kg : 100 mg : 2.0 mg/kg : 40 ml]
- [65-74 kg : 125 mg : 1.9 mg/kg : 45 ml]
- [≥ 75 kg : 150 mg : 2.0 mg/kg : 50 ml]
Acetaminophen 1 gram (tablets) 4 times daily.
Patient Controlled Analgesia Pump with morphine 1 milligram per dose.
干预措施: Levobupivacaine (Drug)
Levobupivacaïne
Fascia Iliaca Compartment Block with Levobupivacaine Hydrochloride (weight based dosage and volume)
Ideal Body Weight : Levobupivacaïne dose (mg) : Dose/kilogram (mg/kg) : Total volume (ml)
- [<64 kg : 100 mg : 2.0 mg/kg : 40 ml]
- [65-74 kg : 125 mg : 1.9 mg/kg : 45 ml]
- [≥ 75 kg : 150 mg : 2.0 mg/kg : 50 ml]
Acetaminophen 1 gram (tablets) 4 times daily.
Patient Controlled Analgesia Pump with morphine 1 milligram per dose.
干预措施: Acetaminophen (Drug)
Levobupivacaïne
Fascia Iliaca Compartment Block with Levobupivacaine Hydrochloride (weight based dosage and volume)
Ideal Body Weight : Levobupivacaïne dose (mg) : Dose/kilogram (mg/kg) : Total volume (ml)
- [<64 kg : 100 mg : 2.0 mg/kg : 40 ml]
- [65-74 kg : 125 mg : 1.9 mg/kg : 45 ml]
- [≥ 75 kg : 150 mg : 2.0 mg/kg : 50 ml]
Acetaminophen 1 gram (tablets) 4 times daily.
Patient Controlled Analgesia Pump with morphine 1 milligram per dose.
干预措施: Morphine (Drug)
Levobupivacaïne
Fascia Iliaca Compartment Block with Levobupivacaine Hydrochloride (weight based dosage and volume)
Ideal Body Weight : Levobupivacaïne dose (mg) : Dose/kilogram (mg/kg) : Total volume (ml)
- [<64 kg : 100 mg : 2.0 mg/kg : 40 ml]
- [65-74 kg : 125 mg : 1.9 mg/kg : 45 ml]
- [≥ 75 kg : 150 mg : 2.0 mg/kg : 50 ml]
Acetaminophen 1 gram (tablets) 4 times daily.
Patient Controlled Analgesia Pump with morphine 1 milligram per dose.
干预措施: Fascia Iliaca Compartment Block with Levobupivacaine (Procedure)
Placebo
Fascia Iliaca Compartment Block with placebo (Sodium Chloride 0.9%), similar volume to experimental arm.
Ideal Body Weight : Total volume (ml)
- [<64 kg : 40 ml]
- [65-74 kg : 45 ml]
- [≥ 75 kg : 50 ml]
Acetaminophen 1 gram (tablets) 4 times daily.
Patient Controlled Analgesia Pump with morphine 1 milligram per dose.
干预措施: Placebo (Drug)
Placebo
Fascia Iliaca Compartment Block with placebo (Sodium Chloride 0.9%), similar volume to experimental arm.
Ideal Body Weight : Total volume (ml)
- [<64 kg : 40 ml]
- [65-74 kg : 45 ml]
- [≥ 75 kg : 50 ml]
Acetaminophen 1 gram (tablets) 4 times daily.
Patient Controlled Analgesia Pump with morphine 1 milligram per dose.
干预措施: Acetaminophen (Drug)
Placebo
Fascia Iliaca Compartment Block with placebo (Sodium Chloride 0.9%), similar volume to experimental arm.
Ideal Body Weight : Total volume (ml)
- [<64 kg : 40 ml]
- [65-74 kg : 45 ml]
- [≥ 75 kg : 50 ml]
Acetaminophen 1 gram (tablets) 4 times daily.
Patient Controlled Analgesia Pump with morphine 1 milligram per dose.
干预措施: Morphine (Drug)
Placebo
Fascia Iliaca Compartment Block with placebo (Sodium Chloride 0.9%), similar volume to experimental arm.
Ideal Body Weight : Total volume (ml)
- [<64 kg : 40 ml]
- [65-74 kg : 45 ml]
- [≥ 75 kg : 50 ml]
Acetaminophen 1 gram (tablets) 4 times daily.
Patient Controlled Analgesia Pump with morphine 1 milligram per dose.
干预措施: Fascia Iliaca Compartment Block with placebo (Procedure)
结局指标
主要结局
Mean morphine consumption in milligrams per hour with PCA pump, extracted from PCA-pump memory (mg / hour).
时间窗: From FICB placement up to 6 hours.
The primary objective is to assess if ultrasound guided FICB with levobupivacaïne results in reduced morphine consumption in ED patients with a proximal femoral fracture at six hours after FICB placement. The morphine consumption will be extracted from the memory from the PCA pump.
次要结局
- Average of PCA-pump requests for morphine per hour (presses / hour)(Time from FICB placement until operation, up to 24 hours. Time point: each hour)
- Average time to first morphine administration with PCA-pump (minutes)(Time from FICB placement until operation, up to 24 hours.)
- Patients with occurence of NRS > 3.(Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.)
- Difference in pain scores at movement.(Time from FICB placement until operation, up to 24 hours. Time point: each hour)
- Morphine consumption in milligrams per hour at each hour in the time preceding operation. (mg / hour)(Time from FICB placement until operation, up to 24 hours. Time point: each hour)
- Average pain score at different time points.(Time from FICB placement until operation, up to 24 hours. Time point: each hour)
- Number of patients with a delirium in preoperative period.(Time from FICB placement until operation, up to 24 hours. Time point at 24 hours.)
- The number of patients with morphine related side effects.(This will be assessed by the nurse at the rounds each shift up to 3 times daily until operation or up to 24 hours.)
- Number of patients with treatment-related adverse events as assessed by CTCAE v4.0.(Time from FICB placement until operation, up to 24 hours.)
- Time spent on FICB placement in seconds.(The time from needle entering patient, until procedure is terminated by the emergency physician.)
