Rebound Pain at Block Resolution After Operations for Distal Radius Fractures With a Volar Plate in Brachial Plexus Block
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- Differences between groups in highest pain scores first 24 hours after surgery
研究概览
简要总结
Many patients have strong pain at brachial plexus block resolution after operations for distal radius fractures with a volar plate. This study investigates if a single dose of dexamethasone in addition to a standard pain regime have an effect on postoperative pain. The primary endpoint is difference in the highest pain score first 24 hours after surgery. The investigators will also look at pain scores and analgesics consumption first few hours after surgery and at different times up to 2 years after surgery.
详细描述
This double-blind randomized clinical study evaluates pain, analgesic consumption and different measurements of patients satisfaction after operations for distal radius fractures with a volar plate in the day-care surgery unit. All patients will receive paracetamol and etoricoxib as oral premedication. Patients will be operated in infraclavicular brachial plexus block with ropivacaine 7,5 mg/ml. Patients in the intervention group will receive a single dose of 16 mg dexamethasone during the operation. Patients in the control group will receive NaCl iv.
After surgery, iv and oral rapid release oxycodone as needed while in hospital. After discharge (after 2-4 hours), etoricoxib for 2 days, controlled release oxycodone, total of 3 doses. Rapid release oxycodone as needed.
Patients will be followed up by telephone interviews at different times 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Distal radius fracture planned for operation with a volar plate
- •0-20 days after trauma
- •AO classification A, B, and C
- •ASA 1 and 2
- •Age 18-65
- •BMI 18-35
- •Able to communicate in Norwegian
排除标准
- •Chronic pain
- •Other injuries
- •Pregnancy
- •Known allergic reactions to medicines used in the study
研究组 & 干预措施
Dexamethasone
Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.
干预措施: Dexamethasone (Drug)
Dexamethasone
Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.
干预措施: Paracetamol (Drug)
Dexamethasone
Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.
干预措施: EtoriCoxib (Drug)
Dexamethasone
Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.
干预措施: Oxycodone (Drug)
Dexamethasone
Single dose of dexamethasone (Dexagalen) 16 mg iv during operation.
干预措施: Ropivacaine (Drug)
Control
Single dose of NaCl, 4 ml, iv during operation.
干预措施: NaCl (Control) (Drug)
Control
Single dose of NaCl, 4 ml, iv during operation.
干预措施: Paracetamol (Drug)
Control
Single dose of NaCl, 4 ml, iv during operation.
干预措施: EtoriCoxib (Drug)
Control
Single dose of NaCl, 4 ml, iv during operation.
干预措施: Oxycodone (Drug)
Control
Single dose of NaCl, 4 ml, iv during operation.
干预措施: Ropivacaine (Drug)
结局指标
主要结局
Differences between groups in highest pain scores first 24 hours after surgery
时间窗: 24 hours
次要结局
- Differences in pain scores after 6 months and 1 year(6 months and 1 year)
- Differences between groups in sleep quality assessed with Likert scale(24 hours)
- Differences between groups in nausea postoperatively assessed with Likert scale(30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours)
- Differences between groups in vomiting postoperatively assessed with Likert scale(30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours)
- Differences between groups in itching postoperatively assessed with Likert scale(30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours)
- Differences in time to first pain score under 4 after block resolution(7 days)
- Differences in side effects(1 year)
- Differences in Patient Rated Wrist/Hand Evaluation (PRWHE) scores after 6 weeks(6 weeks)
- Differences in pain scores after 30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours(30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours)
- Differences in analgesic consumption(1 hours, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours, 1 week, 6 weeks, 6 months, 1 year)
- Differences between groups in sedation postoperatively assessed with Likert scale(30 min, 1 hour, 2 hours, 4 hours, 8 hours, 24 hours, 36 hours, 72 hours)
- Differences in pain scores after 36 hours, 3 days, 7 days, 6 weeks(36 hours, 3 days, 7 days, 6 weeks)
- Differences in block duration(20 hours)
研究者
Anne Holmberg
Principal investigator
Oslo University Hospital