Determination of the Initial Minimum Effective Dose of 0.5% Bupivacaine With 20mcg of Fentanyl Via a Spinal Catheter for Operative Fixation of Fractured Neck of Femur.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up to T10 on the side of FNF
研究概览
简要总结
Fractured neck of femur (FNF) is a common cause of admission to hospital in elderly patients with multiple comorbidities. Anaesthetic management of this patient group is extremely challenging.Neuraxial anaesthesia with minimum doses of local anaesthetic agents administered via a spinal catheter leads to better cardiovascular stability.The minimum dose of local anaesthetic with intrathecal fentanyl was not established yet.We propose to study and determine the initial minimum local anaesthetic dose (MLAD) of 0.5% bupivacaine with 20 mcg of fentanyl administered via a spinal catheter to achieve a sensory block up to T10 for the operative fixation of FNF.We will use a previously well established Dixon and Massey "up-and-down method" to calculate initial MLAD in this prospective, observational trial.
Objectives: We would like to determine the initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl administered via a spinal catheter required to achieve a sensory block up to T10 on the side of FNF.
Outcomes
Primary outcome:
- Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up to T10 on the side of FNF.
Secondary outcomes: 2. Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative fixation of fractured neck of femur. 3. The effect on haemodynamic variables (blood pressure, heart rate). 4. Incidence of side effects 5. The length of postoperative analgesia (the time from the last dose of local anaesthetic administered intrathecally to VAS>3). 6. The time to first rescue analgesic requirement
Study Design Prospective, observational trial.
Study Size Based on the previously well established Dixon and Massey "up-and-down method"(10), we will recruit patients until a successful spinal block has been achieved in six consecutive patients who received a specific dose. This is the requirement to calculate the initial MLAD.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fractured neck of femur
- •Above 60 years
- •American Society of Anesthetists(ASA) I to III
排除标准
- •Patient refusal
- •Outside Age Range
- •Contraindications to spinal anaesthesia
- •Head injury or other associated injuries
- •Loss of consciousness and signs of acute coronary syndrome
- •Mini-Mental Score < 25 (Appendix 2)
- •Allergy to bupivacaine, lignocaine or fentanyl
结局指标
主要结局
Initial MLAD of 0.5% bupivacaine with 20mcg of fentanyl required for a sensory block up to T10 on the side of FNF
时间窗: 15min
A blinded observer will assess the dermatome level of sensory blockade with an ice-cold test (ethyl-chloride spray) bilaterally after the injection of the local anaesthetic. Block assessment will be performed every 5min up to 15 min after completion of the initial intrathecal injection. Sensory block up to T10=positive result Sensory block below T10=negative result.
次要结局
- The effect on haemodynamic variables (blood pressure, heart rate).(Duration of surgery.)
- Total dose of 0.5% bupivacaine with 20mcg of fentanyl required for the operative fixation of fractured neck of femur(Duration of surgery.)
研究者
tomas hitka
Clinical fellow in Regional Anaesthesia
Cork University Hospital