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临床试验/2024-514795-41-00
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

发起方
Oslo University Hospital HF
申办方类型
Hospital/Clinic/Other health care facility
责任方
Principal Investigator
主要研究者

Secretary of the Department of Anesthesia and Intensive Care Medicine, Ullevål

Scientific

Oslo University Hospital HF

研究点 (1)

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