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, Parallelgroup, 2-arm, Triple Blinded Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 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
研究概览
简要总结
The goal of this clinical trial is to see if the concentration of a local anesthetic (ropivacaine) in peripheral nerve block is related to the severness of pain after surgery of distal radius fractures in adults.
The main questions it aims to answer are:
- Is concentration of ropivacaine related to severeness, duration and type of postoperative pain?
- Is concentration of ropivacaine related to analgetic consumption after surgery?
- Is concentration of ropivacaine related to block sucess rate during surgery and patient satisfaction after surgery?
Researchers will compare ropivacaine 3.75 mg/ml and 7.5 mg/ml used in brachial plexus peripheral nerve block. Participipants are randomized to one of the two concentrations. The peripheral nerve block is standard anesthetic treatment for distal radius fractures scheduled for volar plate surgery at Oslo University Hospital. All other treatment for the condition will be the same as standard treatment.
Participants will answer a questionnaire regarding pain, physical function, medication and life quality at different points of time after surgery, up to 6 weeks after surgery.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with distal radius fracture, scheduled for volar plate surgery
- •Surgery up to 20 days after fracture trauma
- •18 to 80 years old (inclusive)
- •ASA 1, 2 or stable ASA 3
- •Body Mass Index (BMI) 18 to 40 kg/m2 (inclusive)
- •Weight of 50 kg or more
- •Ability to communicate sufficiently in a scandinavian language
- •Capable of giving a signed informed consent
- •Ability and willingness to understand og be compliant to the study
排除标准
- •Contemporaneous painful injuries
- •Existing long-term pain
- •Peripheral nerve damage in the arm with radius fracture
- •Patients who prior to fracture trauma use opioids, psycothropic drugs or medication, with or without prescription, with significantly sedative effect on regular basis.
- •Excessive use of alcohol (more than 15 units of alchol per week for men, more than 8 units of alchol per week for women, or patients reporting to be incapable of avoiding alcohol as long as they use strong opioids).
- •Progressive neurologic disease (inclusive diabetic neuropathy).
- •Skin infection at the site for brachial plexus nerve block
- •Other contraindications for brachial plexus nerve block
- •Contraindications for ropivacaine, paracetamol, etoricoxib, dexamehtasone or oxycodone
- •Previous allergic reaction to local anaesthetics or etoricoxib, dexamethasone, oxycodone or paracetamol.
- •Pregnant or breast-feeding women at surgery day (they do not get excluded if they become pregnant in the follow up period after intervention and surgery)
研究组 & 干预措施
Low concentration
Ropivacaine 3.75 mg/ml
干预措施: Ropivacaine concentration low (Drug)
High concentration
Ropivacaine 7.5 mg/ml
干预措施: Ropivacaine concentration high (Drug)
结局指标
主要结局
Worst pain score during the first 48 hours after surgery
时间窗: 48 hours after end of surgery
Pain score on Verbal Numeric Rating Scale (VNRS) from 0 to 10, where 0 represents no pain at all and 10 represents worst pain imaginable.
次要结局
- Pain score at different points of time after surgery(From baseline, end of surgery, until 6 weeks after surgery.)
- Patient satisfaction(From enrollment until 6 weeks after surgery)
- Rebound pain(From end of surgery until nerve block resolution, normally within the first 48 hours after surgery.)
- Duration of moderate and strong pain(From baseline, end of surgery, until first time patient reports VNRS below 7 and/or 4, normally within the first 48 hours.)
- Average and worst pain experience after surgery at different points of time(From baseline, end of surgery, until 7 days after surgery.)
- Long-lasting pain(From baseline, end of surgery, until 6 weeks after surgery.)
- Analgesic consumption after surgery(From baseline, end of surgery, until 6 weeks after surgery.)
- Duration of motoric and sensoric nerve block(From intervention, peripheral nerve block (needle out), until motoric and sensory resolution of nerve block, normally within the first 48 hours after intervention.)
- Life quality(From baseline, end of surgery, until 6 weeks after surgery)
- Quality of long-term pain(6 weeks after baseline, intervention and surgery.)
- Block success rate(From intervention, when nerve block is performed, until 2 hours after surgery.)
研究者
Anette Aasen
Principal Investigator
University of Oslo