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临床试验/NCT07149168
NCT07149168已完成1 期

Role of Pericapsular Nerve Block Using Dexmedetomidine and Bupivacaine in Improving the Outcome of Patients Undergoing Hip Surgery Under Spinal Anesthesia

Ain Shams University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年12月10日最近更新:
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
60
试验地点
1
主要终点
The success rate of achieving adequate spinal anesthesia.

研究概览

简要总结

the investigators will compare the effectiveness and safety of the pericapsular nerve block (PENG) using dexmedetomidine and bupivacaine before giving spinal anesthesia in improving the quality and success rate of spinal anesthesia for Fracture Neck Femur surgery versus spinal anesthesia alone.

详细描述

- Pre-operative settings: Patients scheduled for Fracture Neck Femur surgery under spinal anesthesia will be thoroughly evaluated pre-operatively. A detailed medical history will be obtained, and all patients will undergo a comprehensive physical examination, with particular attention to neurological assessment to exclude any pre-existing conditions that might influence the study outcomes. Additionally, pre-operative laboratory tests, including complete blood count, and coagulation profile, will be reviewed to ensure patient eligibility and safety.

2- Intraoperative Settings: Monitoring: Upon entering the operating room, standard monitoring will be applied to all patients, including pulse oximetry (SpO2), non-invasive blood pressure (NIBP), heart rate (HR), and electrocardiogram (ECG). Baseline measurements will be recorded before any anesthetic intervention.

Intravenous Access: An intravenous (IV) cannula will be inserted, and IV fluids will be initiated.

Group A (Control Group):

For spinal anesthesia in fracture neck femur surgery, a typical dose of 0.5% hyperbaric bupivacaine ranges from 0.1 to 0.15 mg/kg (2 to 3 mL), depending on the patient's height and clinical condition. Lower doses are used for shorter or elderly patients, while taller patients may require higher doses to achieve the desired block level at T10-T12.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged ≥ 18 years, scheduled for elective fracture neck femur surgery, • Physical status: ASAI-III.

排除标准

  • • Patients with contraindications to spinal anesthesia or regional blocks as:
  • significant coagulopathy
  • Known allergies to drugs used (Bupivacaine or dexmedetomidine)
  • Infection at site of injection
  • Cardiac patients with significant valve stenosis or sever pulmonary hypertension

研究组 & 干预措施

control

Active Comparator

patients will recieve For spinal anesthesia in fracture neck femur surgery, a typical dose of 0.5% hyperbaric bupivacaine ranges from 0.1 to 0.15 mg/kg (2 to 3 mL), depending on the patient's height and clinical condition. Lower doses are used for shorter or elderly patients, while taller patients may require higher doses to achieve the desired block level at T10-T12

干预措施: Bupivacain (Drug)

group B

Active Comparator

Patients in this group will first receive a pericapsular nerve block (PENG) before spinal anesthesia.

The PENG block will be performed using a mixture of 0.25% bupivacaine (1.25 to 2.5 mg/kg.) combined with dexmedetomidine at a dose of 1.25 mcg/kg. This combination provides prolonged analgesia, enhances block effectiveness, and minimizes motor blockade, ensuring optimal pain control for fracture neck femur surgery.

Following the successful administration of the PENG block, spinal anesthesia will be administered as described for Group A.

干预措施: Dexmedetomidin (Drug)

结局指标

主要结局

The success rate of achieving adequate spinal anesthesia.

时间窗: from injection to 24 hr post operative

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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