The Effect of Protracted Saphenous Nerve and Obturator Nerve Block Versus Saphenous Nerve Block Versus Local Infiltration Analgesia on Opioid Consumption, Pain, Block Duration of Action and Mobilization After Total Knee Arthroplasty.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Opioid consumption
研究概览
简要总结
Purpose:
The purpose of this study is to evaluate the postoperative analgesic effect of a combined Saphenous nerve block and Obturator nerve block with local infiltration analgesia in the tissue around the knee after surgery with knee replacement. In the combined nerve blocks we use a mixture of Bupivacaine, Adrenaline, Clonidine and Dexamethasone ("protracted mixture") and the local infiltration consist of Ropivacaine, Adrenaline and Toradol. Our hypothesis is that the combined nerve blocks with protracted mixture prolongs block duration, reduces pain and reduces the need for morphine and thus reduce side effects such as nausea, vomiting and lethargy compared to the current treatment with local infiltration analgesia.
Background:
Nerve blocks as analgesic treatment after orthopedic surgery is a recognized and proven procedure. The nerve blocks have the disadvantage that not only do they anesthetize the sensory nerve fibers but also the nerve fibers to the muscles of the leg. The Saphenous nerve block causes only stunning of sensory nerves to the knee region. The Obturator nerve block causes both stunning of the sensory nerves to the knee region and the thighs inward leading muscles, and does not affect the patient's mobilization capacity.
Both blocks are known to be a good addition to the analgesic treatment. Bupivacaine is a well-known local anesthetic. Adrenaline, Clonidine and Dexamethasone have also been used in other studies, in addition to the local anesthetic agent, and has been shown to prolong the effect of the nerve block. Saphenous and Obturator nerve block with all four drugs Bupivacaine, Adrenaline, Clonidine and Dexamethasone has not been systematically investigated in knee replacement surgery, and it is not known whether this method will provide better pain treatment.
Method
The patient can receive one of three treatments, determined randomly:
- A. Saphenous and Obturator nerve block with active anesthetics (Bupivacaine, Adrenaline, Clonidine, Dexamethasone) and local block around the knee joint with placebo medicine (normal saline).
- B. Saphenous block with active anesthetics and both Obturator nerve block and local block around the knee joint with placebo medicine (normal saline).
- C. Both block with placebo medicine (normal saline) and local block around the knee joint with effective local anesthetic.
Neither patient, investigator or staff around the patient will have knowledge of which treatment the patient has received.
The blocks will be injected before the operation and local infiltration around the knee joint will be given by the surgeon during the operation.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 50 years
- •Patients set to cemented Total knee arthroplasty in spinal block
- •Patients who have given written informed consent to participate in the study after having understood the contents of the protocol and limitations fully
- •Illness score 1-3
排除标准
- •Patients who can not cooperate with the investigation
- •Patients who do not understand or speak Danish
- •Patients receiving immunosuppressive therapy
- •Patients with a treatment-dependent diabetes mellitus
- •Patients with known neuropathy in the lower limbs
- •Allergy to those drugs used in the study
- •Alcohol and / or drug abuse - the investigator's opinion
- •Patients who can not tolerate Non steroid analgesic drugs
- •Use of strong opioid several times a day (morphine, ketogan, Oxynorm, methadone, fentanyl)
研究组 & 干预措施
Combined saphenous nerve and obturator nerve block
干预措施: Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram (Drug)
Saphenous nerve block
干预措施: Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram (Drug)
Local infiltration analgesia
干预措施: Ropivacaine + Toradol + Adrenaline (Drug)
结局指标
主要结局
Opioid consumption
时间窗: 1 to 24 hours postoperatively
次要结局
- Timed Up and Go test(1-2 hours preoperatively, 24 hours and 2 weeks postoperatively)
- Pain Score by passive flexion of the knee joint from 0-90 degrees(Time 1, 2, 5, 7, 24, 31, 48 hours postoperatively)
- Vomiting(Number of between 24 hours postoperatively)
- Patient-reported consumption of opioid(From the discharge date from hospital to ambulatory monitoring 2 weeks postoperatively)
- Patient-reported time to first postoperative breakthrough pain(Time 1 - 48 hours postoperatively)
- Movement of the knee joint(1-2 hours preoperatively, 24 hours and 2 weeks postoperatively)
- Opioid consumption(1 to 48 hours postoperatively)
- Ondansetron(Consumption at time 24 hours postoperative)
- Number of nights with patient-reported sleep disruptions(Time 48 hours postoperatively)
- Discharge time from the hospital(Time 1 hour to 2 weeks postoperatively)
- Time at mobilization to walk with or without support in the form of a walker, crutches or caregivers.(Time 1 to 48 hours postoperatively)
- Cumulated Ambulation Score to illustrate the basic level of mobilization(1-2 hours pre-operatively, during the first postoperative mobilization, and time 24 hours postoperatively)
- Pain Score at rest(Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively)
- Duration of stay in the post anesthesia care unit(1 - 48 hours postoperatively)
- Nausea(Time 1, 2 , 5, 7 , 24, 31 and 48 hours postoperatively .)
- Quantitative satisfaction of pain(At 2 weeks postoperatively)
- Isometric tests of muscle strength in the hip adductors(1-2 hours preoperatively and again 30 minutes after the application of obturator nerve blockade)
研究者
Charlotte Runge
MD
Regionshospitalet Silkeborg