The Effect of Ultrasound Guided Blockade of the Femoral Nerve, the Anterior Division of the Obturator Nerve, and the Lateral Femoral Cutaneous Nerve on Postoperative Pain, Morphine Consumption, and Mobilization After Total Hip Arthroplasty.
试验速览
- 阶段
- 不适用
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
Patients undergoing total hip arthroplasty may experience severe postoperative pain. This is normally treated with opioids, which can cause side effects such as nausea, vomiting, obstipation and sedation. The hypothesis is that patients receiving peripheral nerve blockade of three nerves leading pain stimuli from the hip will experience less pain, will consume less opioid and therefore have less side effects, and will be mobilized more quickly than patients not receiving the peripheral nerve blockade.
详细描述
Total hip arthroplasty (THA) may cause significant postoperative pain. The patients are often elderly, and frequently have other diseases or ailments. Postoperative pain treatment must focus on effective pain relief, keeping adverse effects to a minimum, enhancing physical rehabilitation and reducing postoperative morbidity.
Postoperative pain after hip surgery can be treated in different ways; i.e. paracetamol, NSAIDs, opioids, peripheral nerve blocks and epidural catheter. The choice seems to be influenced by local experience, education and personal preferences. Frequently, a multimodal approach is used with a combination of weak analgetics, opioids and maybe regional anaesthetic techniques.
The sensory innervation of the hip is through branches from the lumbar and sacral plexuses. The femoral nerve (FN), the obturator nerve (anterior branch) (ONA) and the lateral femoral cutaneous nerve (LCFN) all stem from the lumbar plexus. The FN and ONA directly supply the hip joint. LCFN innervates the skin on the lateral part of the thigh, where the incision for THA is often made.
The psoas compartment block provides good pain relief after THA, but the block can be associated with more frequent complications than other regional blockades for the lower extremity. Furthermore, the technique is difficult, and requires sub-specialized anaesthetists. In addition, it is often necessary to use electrical nerve stimulation together with ultrasound guidance to achieve a sufficient block.
Blockade of the FN is standard for hip fractures in our hospital, but not standard for THA. Because of the analgetic effect in hip fractures, the PROSPECT group recommends blockade of FN for THA as well, though specific evidence is scarce on the subject.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Minimum 18 years of age
- •Patients scheduled for primary, unilateral hip arthroplasty with spinal anaesthesia
- •Patients who have given their written and informed consent to participation after having understood the content and limitations of the protocol fully
排除标准
- •Patients who are not able to co-operate
- •Patients who do not speak or understand Danish
- •Daily use of opioids corresponding to 40 mg of morphine daily
- •Allergy towards the drugs used in the study
- •Drug abuse (investigators judgement)
- •Alcohol consumption larger than advised by the Danish National Board of Health
- •Spinal anaesthesia is contraindicated or the patient wants a general anaesthesia
- •Patients in whom the blockade procedure or the spinal anaesthesia procedure cannot be completed because of technical difficulties
研究组 & 干预措施
K: Control group
Sham blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with saline.
干预措施: Saline (Drug)
B3: Blockade of three nerves
Peripheral nerve blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with ropivacaine.
干预措施: Ropivacaine (Drug)
B3: Blockade of three nerves
Peripheral nerve blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with ropivacaine.
干预措施: Ultrasound (Device)
B3: Blockade of three nerves
Peripheral nerve blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with ropivacaine.
干预措施: Peripheral nerve blockade (Procedure)
B3: Blockade of three nerves
Peripheral nerve blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with ropivacaine.
干预措施: Total hip arthroplasty (Procedure)
B3: Blockade of three nerves
Peripheral nerve blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with ropivacaine.
干预措施: Bupivacaine (Drug)
B2: Blockade of 2 nerves
Peripheral nerve blockade of the anterior division of the obturator nerve and the lateral femoral cutaneous nerve with ropivacaine.
Sham blockade of the femoral nerve with saline.
干预措施: Ropivacaine (Drug)
B2: Blockade of 2 nerves
Peripheral nerve blockade of the anterior division of the obturator nerve and the lateral femoral cutaneous nerve with ropivacaine.
Sham blockade of the femoral nerve with saline.
干预措施: Ultrasound (Device)
B2: Blockade of 2 nerves
Peripheral nerve blockade of the anterior division of the obturator nerve and the lateral femoral cutaneous nerve with ropivacaine.
Sham blockade of the femoral nerve with saline.
干预措施: Peripheral nerve blockade (Procedure)
B2: Blockade of 2 nerves
Peripheral nerve blockade of the anterior division of the obturator nerve and the lateral femoral cutaneous nerve with ropivacaine.
Sham blockade of the femoral nerve with saline.
干预措施: Saline (Drug)
B2: Blockade of 2 nerves
Peripheral nerve blockade of the anterior division of the obturator nerve and the lateral femoral cutaneous nerve with ropivacaine.
Sham blockade of the femoral nerve with saline.
干预措施: Total hip arthroplasty (Procedure)
B2: Blockade of 2 nerves
Peripheral nerve blockade of the anterior division of the obturator nerve and the lateral femoral cutaneous nerve with ropivacaine.
Sham blockade of the femoral nerve with saline.
干预措施: Bupivacaine (Drug)
K: Control group
Sham blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with saline.
干预措施: Ultrasound (Device)
K: Control group
Sham blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with saline.
干预措施: Peripheral nerve blockade (Procedure)
K: Control group
Sham blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with saline.
干预措施: Total hip arthroplasty (Procedure)
K: Control group
Sham blockade of the femoral nerve, the anterior division of the obturator nerve, and the lateral femoral cutaneous nerve with saline.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
Pain
时间窗: At intervals during the first 48 hours after surgery
Verbal Rating Scale score (0-10) at rest.
次要结局
- Length of stay(One week)
- Pain(At intervals during the first 48 hours after surgery)
- Vomiting(In intervals during the first 48 hours after surgery)
- Mobilization(The first 48 hours after surgery)
- Opioid consumption(In intervals during the first 48 hours after surgery)
- Bowel movement(Within the first 48 hours after surgery)
- Sedation(At intervals during the first 48 hours after surgery)
- Nausea(At intervals during the first 48 hours after surgery)
- Mental and physical condition(Before and at intervals during the first 48 hours after surgery)
研究者
Kenneth Jensen
MD, BBA
Bispebjerg Hospital