Postoperative Analgesia Following Surgery for Fractured Neck of Femur: a Comparison of Periarticular Infiltration of Local Anaesthetic With Systemic Postoperative Analgesics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- VRS pain score on passive movement 12 hours after the surgery
研究概览
简要总结
The purpose of this study is to determine that periarticular levobupivacaine infiltration after surgical fixation of fractured neck of femur will improve the early postoperative pain sensation.
详细描述
Fractured neck of femur is a common cause of admission to hospital for elderly patients and requires operative fixation, which is usually associated with significant pain in the early postoperative period. Postoperative pain can delay mobilisation and discharge from the hospital. The administration of opioid drugs in the postoperative period is associated with significant adverse effects. Following total knee replacements local anaesthetic infiltration led to a significantly decreased duration of hospital stay due to decreased postoperative pain (1). Continuous postoperative wound infiltration after shoulder surgery with ropivacaine, (2 mg/ml and 3.75 mg/ml), results in lower pain scores and opioid requirement compared with infiltration of placebo (2). Effective pain management in the postoperative period is important to aid early mobilisation and decrease morbidity (3).
In our hospital, surgical fixation of fractured neck of femur is routinely performed under spinal anaesthesia with intrathecal bupivacaine.. This provides excellent conditions for surgery and gives satisfactory analgesia in the early postoperative period. However, clinical observation indicates that a period of inadequate analgesia often occurs after the offset of intrathecal local anaesthetic effect. Wound infiltration with local anaesthetic after total hip and knee replacement has been investigated as an alternative method of postoperative analgesia (4-8).
Hypotheses Perioperative infiltration of the surgical site with levobupivacaine (in addition to standard systemic analgesics) decreases pain during the first day after surgery.
This technique decreases post-operative systemic opioid requirements and the incidence of associated adverse effects To test these hypotheses we propose to carry out a prospective, randomized controlled clinical study in patients undergoing surgical fixation of fractured neck of femur under spinal anaesthesia.
To our knowledge, a study comparing these two techniques has not been performed previously.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for surgical fixation of fractured neck of femur
- •consent to spinal anaesthesia
- •ASA grade 1-3
排除标准
- •Patients refusal
- •Mini mental scores less than 25
- •Allergy to bupivacaine, morphine, paracetamol and diclofenac
- •Skin lessons/ infections at the site of injection
- •Uncorrected renal dysfunction
- •Coagulation disorders
研究组 & 干预措施
Infiltration group
The patients in this group will receive spinal anaesthesia with intrathecal bupivacaine 0.5% 2.0ml and will receive peri-surgical site infiltration before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight with epinephrine made up to a volume of 1.5ml/kg with saline.
干预措施: Levobupivacaine infiltration group (Drug)
结局指标
主要结局
VRS pain score on passive movement 12 hours after the surgery
时间窗: 12 hours after the surgery
We will assess the patients 12 hours after the surgical fixation of fractured neck of femur on passive movement (elevating the limb with 30 degree)
次要结局
- VRS pain scores in the first two postoperative day.(48 hours)
研究者
Szilard Szucs
Clinical Lecturer in Anaesthesia
Cork University Hospital