2024-514795-41-00招募中4 期
Rebound pain after volar plate surgery in infraclavicular brachial plexus block with ropivacaine 3.75 mg/ml compared with 7.5 mg/ml. A prospective, triple blinded randomised controlled trial
Oslo University Hospital HF1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年1月15日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Worst pain score during the first 48 hours after surgery, as measured by Verbal Numeric Rating Score (VNRS) 0-10
研究概览
简要总结
To investigate if severity of postoperative pain may be related to the concentration of ropivacaine.
入排标准
- 年龄范围
- 18 years 至 65+ years(18-64 Years, 65+ Years)
- 接受健康志愿者
- 否
入选标准
- •Adult patients with radius fracture, scheduled for volar plate surgery within 20 days after the fracture trauma
- •ASA I, II and stable ASA III patients
- •Body Mass Index (BMI) 18-40 kg/m2
- •Body weight 50 kg or above
- •Ability to understand and communicate sufficiently in a Scandinavian language
- •Capable of giving signed informed consent
排除标准
- •Progressive neurologic disease
- •Previous allergic reaction to local anaesthetics or etoricoxib, dexamethasone, oxycodone or paracetamol.
- •Existing long-term pain
- •Peripheral nerve damage in the fractured arm
- •Breast-feeding women or women pregnant on the inclusion day
- •Contraindications for ropivacaine, etoricoxib, dexamethasone, paracetamol or oxycodone
- •Excessive intake of alcohol or illegal drugs
- •Use of opioids, psychotropic drugs, sleep medication or medication with sedative effect on a regular basis prior to fracture trauma.
- •Other painful injuries
- •Skin infection or other contraindications for brachial plexus nerve block
结局指标
主要结局
Worst pain score during the first 48 hours after surgery, as measured by Verbal Numeric Rating Score (VNRS) 0-10
Worst pain score during the first 48 hours after surgery, as measured by Verbal Numeric Rating Score (VNRS) 0-10
次要结局
- Rebound pain, defined as VNRS (0-10) equal or above 7 at block resolution
- Difference in VNRS and Likert scale in the post anesthesia care unit (PACU) 8 hours, 24 hours, 48 hours, 3 days and 7 days after surgery.
- Duration of moderate pain (VNRS 4 or above) and strong pain (VNRS 7 or above).
- Average and worst pain score (VNRS) 8-24 hours, 24-48 hours, last 24 hours at 3 days and 7 days after surgery.
- Pain at rest and with movement at 6 weeks after surgery (VNRS 0-10 and Likert scale)
- Worst pain last week at 6 weeks after surgery and average pain last 24 hours at 6 weeks after surgery.
- Total opioid and analgesic consumption first 8 hours, first 24 hours, 24-48 hours, 48 hours to 1 week and last week at 6 weeks after surgery.
- Duration of motoric and sensoric block from peripheral nerve block (needle out).
- Time from needle out to first rescue analgesic
- Quality of sleep, work ability, social life and cognitive function the first night, 48 hours, 3 days, 7 days and 6 weeks after surgery (Likert scale).
- Number of patients answering yes to the question: Do you have bothersome pain?
- The type of pain experienced at block resolution (heat, cold, burning, prickly, tingling, itchy, squeezing).
- Satisfaction with pain treatment (yes/no)
- Sensory and motor test of adequate nerves after peripheral nerve block before surgery and 1 hour after surgery.
- Was the nerve block adequate for surgery (yes/no)
研究者
Secretary of the Department of Anesthesia and Intensive Care Medicine, Ullevål
Scientific
Oslo University Hospital HF
研究点 (1)
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