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临床试验/NCT02322372
NCT02322372已完成4 期

Comparison of Conventional Dose Spinal Anesthesia With Low-dose Spinal Anesthesia and Femoral Blockade Combination in Outpatient Knee Arthroscopy

Ankara University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
50
试验地点
1
主要终点
Time of sensorial block to regress L2

研究概览

简要总结

The investigators of the current study aimed to evaluate the effect of spinal anesthesia with low dose bupivacaine combined with femoral blockade on duration of anesthesia and time of first analgesic requirement during postoperative period

详细描述

Fifty patients undergoing arthroscopic meniscus repair were included to the current study.

The patients were allocated to two groups as the spinal anesthesia with conventional dose of heavy bupivacaine or spinal anesthesia with low dose heavy bupivacaine combined with femoral blockade.

Blood pressures and heart rates were recorded at the beginning, at the 0th minute following femoral block, at the 0th minute and in two-minute intervals following spinal anesthesia for 20 minutes and in five-minute intervals till the end of surgery.

The sensorial block and motor block in both extremities were recorded in two-minute intervals following spinal anesthesia and in five-minute intervals till the end of surgery The time of sensorial blockade to reach T12, maximum level of sensorial blockade level and the time to reach maximum level of sensorial blockade and the time for regression of sensorial blockade to L2, the time for regression of motor blockade were recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-II patients aged between 25-65 undergoing arthroscopic meniscus repair

排除标准

  • Contraindications to regional anesthesia (coagulopathy, severe aortic stenosis, sever mitral stenosis, increased intracranial pressure, severe hypovolemia, presence of infection on the site of injection)
  • Presence of previous spinal surgery
  • Presence of diabetes mellitus
  • Presence of neurological disturbance
  • Uncooperated patients, patients not accepting to participate the study
  • Allergy to study drugs
  • ASA II-IV patients, BMI >38, Height < 150 cm and >190 cm

研究组 & 干预措施

Group F

Active Comparator

Ultrasound-guided femoral blockade with 15 mL of bupivacaine 0.5% diluted in 15 mL saline was performed in supine position. Then the patient was turned to lateral decubitus position with the operated extremity on dependant position and intrathecal injection of heavy bupivacaine 1 mL (5 mg) was administered from L3-L4 intervertebral space at a rate of 1 mL/20 second.

.

干预措施: Femoral blockade (Drug)

Group S

Active Comparator

The patient was turned to lateral decubitus position with the operated extremity on dependant position and intrathecal injection of heavy bupivacaine 2 mL (10 mg) was administered from L3-L4 intervertebral space at a rate of 1 mL/20 second.

干预措施: Intrathecal anesthesia (Drug)

结局指标

主要结局

Time of sensorial block to regress L2

时间窗: 24 hours

次要结局

  • Time of first analgesic requirement(24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sanem Cakar Turhan

Specialist

Ankara University

研究点 (1)

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