A Prospective Study to Compare the Efficacy of Fascia Iliaca Block Versus Femoral Nerve Block for Proximal Femur Fractures Before Positioning for Spinal Anesthesia in Adult Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- efficacy for managing pain, positioning during proximal femur fracture surgeries conducted under spinal anesthesia
研究概览
简要总结
A prospective study to compare the efficacy of fascia iliaca block versus femoral nerve block for proximal femur fractures before positioning for spinal anesthesia in adult patients.
Objective to assess and compare the efficacy of Fascia Iliaca Block and Femoral Nerve Block for providing analgesia during patient positioning for spinal anesthesia using Visual Analogue Scale for pain.To compare the change in heart rate, blood pressure and saturation.
**Inclusion criteria:**Patients willing to sign informed consent
Male or female patients between 18 to 80 years of age
â Patients belonging to American Society of Anesthesia (ASA) grade I & II.
Patients with isolated proximal femoral fracture posted for elective surgeries under Spinal Anesthesia.
Exclusion criteria: Patients unwilling to participate in the study.
Patients with other fractures of lower limb along with proximal femur fracture.
Patients belonging to ASA grade III or more.
â Psychiatric patients
â Pregnancy & lactating women.
â History of known allergy to study drug.
â Infection at injection site
Coagulation disorders, platelet count less than 80,000.
Any contraindication to spinal anesthesia like raised intracranial pressure, haemodynamic instability, neurological disorders.
â Patients who had previous femoral vascular surgery.
In the supine position, under all aseptic precautions patients will be administered block.A 10 cm visual analogue scale (VAS) score will be recorded before the block and after the block at 3,5,7,10 minutes.Time of onset of analgesia will be assessed and is defined as the time taken from administration of block to reduction of VAS from pre block value.The patients will be made to sit for spinal anesthesia when the VAS score will be less than 4.
Site of Study**:Department of Anaesthesiology, Dhiraj Hospital,S.B.K.S.Medical Instituteand Research Centre, Piparia, Waghodia, Vadodara, Gujarat.**
Study Design**-** Prospective Observational Study
Study Duration**-**The study duration will be till 18 months after getting permission from institutional ethics committee.
Data will be Collected and organized, with numerical data summarized using mean and standard deviation (SD), and categorical data represented by frequency and percentage. For numerical variables, comparisons between groups will be conducted using methods such as unpaired student t-test and/or ANOVA when suitable. For categorical variables, the chi-square test will be applied. A Statistical significance level of p < 0.05 will be deemed statistically significant.
Likely outome/benifit:
The study will provide insights into the comparative efficacy of fascia iliaca block (FIB) versus femoral nerve block (FNB) for managing pain, positioning during proximal femur fracture surgeries conducted under spinal anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who are willing to provide written informed consent.
- •Male and female patients aged eighteen to eighty years.
- •Patients belonging to American Society of Anesthesiologists physical status one and two.
- •Patients with isolated proximal femoral fracture scheduled for elective surgery under spinal anesthesia.
排除标准
- •Patients unwilling to participate in the study.
- •Patients with other fractures of the lower limb along with proximal femur fracture.
- •Patients belonging to American Society of Anesthesiologists physical status three or more.
- •Patients with psychiatric illness.
- •Pregnant and lactating women.
- •Patients with a history of known allergy to the study drug.
- •Patients with infection at the injection site.
- •Patients with coagulation disorders or platelet count less than eighty thousand.
- •Patients with any contraindication to spinal anesthesia such as raised intracranial pressure, hemodynamic instability, or neurological disorders.
- •Patients with a history of previous femoral vascular surgery.
结局指标
主要结局
efficacy for managing pain, positioning during proximal femur fracture surgeries conducted under spinal anesthesia
时间窗: efficacy for managing pain, positioning during proximal femur fracture surgeries conducted under spinal anesthesia at 3,5,7 & 10 minutes.
次要结局
- Time of onset of analgesia(will be assessed and is defined as the time taken from administration of block to reduction of VAS from pre block value.)
- Monitoring of parameters like HR, SBP, DBP,SPO2(will be noted at baseline 5,10,15 minutes after the peripheral nerve block and every 15 minutes till the end of surgery)
研究者
Dr Gargi Yadav
Smt.Bhikiben Kanjibhai Shah Medical Institute and Research Centre