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临床试验/NCT04418674
NCT04418674Unknown不适用

Comparison of Analgesic Effectiveness of Intravenous Ketamine and Fentanyl for Spinal Anesthesia is Sitting Position in Patients With Proximal Femur Fracture

Jenny Bajracharya2 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2020年6月25日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
52
试验地点
2
主要终点
Numeric Rating Scale for Pain

研究概览

简要总结

This is a prospective comparative study which will be conducted in patients with proximal femur fracture undergoing operative interventions under subarachnoid block in sitting position. Ketamine group will receive 0.3mg/kg intravenously and Fentanyl group will receive 1.5mcg/kg before changing the position from supine to sitting for subarachnoid block. Analgesic effectiveness of the two drugs will be compared by Numeric Rating Scale for pain.

Research hypothesis (Null hypothesis) There is no difference in analgesic effectiveness, patient satisfaction, spinal performance and occurrence of adverse effects between Intravenous ketamine and intravenous fentanyl in patients with proximal femur fracture.

Alternate hypothesis Intravenous Ketamine in patients with proximal femur fracture improves the level of analgesia, patient satisfaction, spinal performance and occurrence of adverse effects when compared to intravenous fentanyl.

详细描述

Femur fracture is a common orthopedic problem following trauma in patients of all ages. It is a painful bone injury and is associated with severe pain and distress during preoperative period. Surgical repair is most commonly done in subarachnoid block. However, moving the patient for optimal positioning for spinal needle placement in subarachnoid space leads to severe pain. Adequate analgesia not only improves patient's comfort but has also been shown to improve positioning for subarachnoid block. Several analgesic modalities have been used to decrease movement evoked pain in these patients including the use of intravenous analgesics and blocks. However, there are only few studies comparing intravenous analgesics that alleviated the pain that occurs when changing position for subarachnoid block.

Patient enrollment will be done by the primary investigator one day prior to the surgery. All eligible patients with American Society of Anesthesiologist Physical Status I, II fulfilling the inclusion criteria will be informed about the study and written consent will be obtained in pre operative visit, one day prior to the surgery, in the orthopedic in-patient ward.

All patients will be kept nil per oral for 6 hours for solid, heavy meal, 4 hours for light meal and 2 hours for clear liquid. All the patients will be pre-medicated with Tab Lorazepam 1mg (<50kg) and 2mg (>50kg) orally the night before and in the morning of the surgery.

On the day of surgery, randomization will be done in pre operative holding area and the patient will be transferred to the operation theatre in trolley maintaining the skeletal traction. All standard monitoring devices like electrocardiogram, non-invasive blood pressure monitoring and pulse oximeter will be attached. Standard anesthesia monitoring including 3-lead electrocardiography, oxygen saturation(Spo2), blood pressure(BP) and heart rate(HR) will be done.Baseline Numeric Rating Scale(NRS) for pain at rest and movement will be assessed (movement is defined at 5 cm active vertical movement of the limb).

An intravenous line will be secured with 18 gauge intavenous cannula in the dorsum of hand. Pre-hydration will be started with Ringer's Lactate solution at 5ml/kg/hour.

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)

盲法说明

0.4ml from one 1 ml ampule of 50mg ketamine will be diluted with 9.6ml NS to make a concentration of 2mg Ketamine in each ml in a 10 ml syringe.

One 2ml ampule of 100mcg Fentanyl will be diluted with 8 ml NS to make a concentration of 10mcg in each ml in a 10ml syringe

Ketamine and Fentanyl will be administered as clear fluid from a 10ml syringe labelled as Study drug, therefore, both the patient and investigator will be blinded.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Ketamine

Experimental

Patient will be given Ketamine 0.3mg/kg intravenously before sitting positioning for subarachnoid block.

干预措施: Ketamine (Drug)

Fentanyl

Active Comparator

Patient will be given Fentanyl 1.5mcg/kg intravenously before sitting position for subarachnoid block.

干预措施: Fentanyl (Drug)

结局指标

主要结局

Numeric Rating Scale for Pain

时间窗: 1 to 20 minutes

Level of analgesia for subarachnoid block in sitting position measured by Numeric Rating Rating Scale for pain. Scale ranges from 0 to 10, where 0 is no pain and 10 being maximum/ worst imaginable pain.

次要结局

  • Likert Satisfaction score(1 to 20 minutes)
  • Modified Aldrerte Score(10 to 30 minutes (In post anesthesia care unit))
  • Anesthetist Satisfaction Score(1 to 20 minutes)
  • Adverse effects(1 to 120 minutes (Intraoperatively))
  • Modified Wilson Sedation Scale(1 to 120 minutes (Intraoperatively))
  • Number of attempts for successful spinal needle placement(1 to 20 minutes (While performing subarachnoid block))

研究者

发起方
Jenny Bajracharya
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jenny Bajracharya

Department of Anesthesia, Principal Investigator, Junior resident

B.P. Koirala Institute of Health Sciences

研究点 (2)

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