Peripheral Nerve Block Anaesthesia for Ankle Fracture Surgery - an Exploratory Study: Is Rebound Pain a Problem?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Clinically relevant pain increase based on analysis of Numeric Rating Scale pain score (NRS) area under the curve (AUC) for the time period 12-24 hours compared to 0-12 hours postoperatively.
研究概览
简要总结
The purpose of this exploratory study is to characterize the postoperative pain profile of patients undergoing operation with internal fixation of an ankle fracture under nerve block anaesthesia. Special attention is payed towards the possible existence and clinical relevance of a rebound pain phenomenon upon cessation of the nerve block.
Results are used to guide the set up of a randomized controlled trial on the subject.
详细描述
Peripheral nerve blocks (PNB) are widely used as anaesthesia and postoperative pain control for surgery. Several studies have suggested multiple benefits of PNB's but primarily shown in elective surgery. Acute conditions like ankle fractures have a different pain profile and risks and benefits of PNB's have not been sufficiently researched in these cases.
A recent study (Goldstein et al. 2012) suggested that a rebound pain effect occur upon cessation of PNB effect defined as a pain increase to a significantly higher level than observed in patients with no PNB at the same point after surgery.
With this prospective, exploratory study we aim to examine the postoperative pain profile after PNB anaesthesia for ankle fracture surgery with focus on plausibility of a rebound pain effect (as defined above) upon PNB cessation.
Secondarily to explore a variety of factors related to postoperative pain profile and feasibility of PNB anaesthesia for ankle surgery including efficacy, risk factors, time factors as well as postoperative recovery and overall patient satisfaction. Results will provide focus for a following randomized controlled trial.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients >= 18 years old scheduled for internal fixation of an ankle fracture as defined above.
- •Ability to read and understand Danish and give informed oral and written consent
排除标准
- •Multitrauma patients / other simultaneous fractures
- •Cognitive or psychiatric dysfunction causing expected inability to comply with study protocol
- •"CAVE" nonsteroidal antiinflammatory drugs (NSAID) or Morphine or Local Anaesthetics as evaluated by anesthesiologist for any reason
- •Primary investigator unavailable for PNB administration at scheduled time of operation
- •Infection at PNB injection site
- •Time from fracture to operation > 5 days
- •Existing neuropathy with functional impairment of the fractured extremity
- •Bodyweight < 50 kg
- •Daily use of opioids > 2 weeks preoperatively
- •Pregnancy
- •Nephropathy requiring dialysis
结局指标
主要结局
Clinically relevant pain increase based on analysis of Numeric Rating Scale pain score (NRS) area under the curve (AUC) for the time period 12-24 hours compared to 0-12 hours postoperatively.
时间窗: 0, 2, 4, 6, 9, 12, 15, 18, 21 and 24 hours postoperatively
Pain scores are assessed and marked by the patient on a 0-10 numeric rating pain scale (NRS).
次要结局
- Time to patient estimated cessation of block effect(0-24 hours postoperatively)
- NRS day 1-7 as both "average" and "worst" of the day(Days 1-7 postoperatively)
- Opioid use 12-24 hours compared to 0-12 hours postoperatively(0-24 hours continuous measurement)
- Calculated Composite Score for the time intervals 0-24h, 0-12h and 12-24h postoperatively(0-24 hours postoperatively)
- Time to first opioid dose postoperatively(0-24 hours postoperatively)
- Daily opioid consumption day 1-7(Days 1-7 postoperatively)
研究者
Rune Sort
MD, Research Fellow
Herlev Hospital