A Comparison Of Block Quality In Anterior And Posterior Approach To Sciatic Nerve Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Comparison of sensorial block start time after sciatic nerve block performed with anterior and posterior approaches.
研究概览
简要总结
Co-administration of the sciatic nerve block and femoral nerve block may provide anesthesia and analgesia in patients undergoing lower extremity surgery. Several approaches to sciatic nerve block have been described. The anterior and posterior approaches are two of the approaches used to make the sciatic nerve block. In our study, n = 20 patients for Group A and n = 25 patients for Group P were included. Then, sciatic nerve block and femoral nerve block were performed to each patient by using anterior or posterior approach randomly. After the block is performed, the sensory and motor block start and end times, the first intraoperative fentanyl requirement time and total amount of fentanyl required, the first Diclofenac sodium requirement time, and the total amount of diclofenac sodium that patients required were determined. As the groups were compared to each other; the time to start sensory block was statistically significantly lower, the first fentanyl requirement time was statistically significantly earlier and the total amount of fentanyl required was statistically significantly lower in Group P. Patient satisfaction, anesthesia quality and surgical quality were statistically significantly higher in Group P. In this study, the investigators concluded that if a patient does not have pain secondary to fracture, posterior approach to sciatic nerve block can be performed, whereas, if a patient has pain secondary to fracture, anterior approach to sciatic nerve block can be performed in order to avoid repositioning.
详细描述
Forty five patients were enrolled to the study. These patients were classified in the American Society of Anesthesiologists (ASA) I-II group. The written informed consent of each patient was obtained.
The study was randomized, single blinded and prospectively planned. Randomization was done according to the randomization table prepared by the computer. A single blinded anesthesiologist performed posterior or anterior sciatic nerve block and femoral block and left the operating room after the patient was corrected after the nerve block was completed and another anesthesiologist followed the patient without knowing what approach was used. Before initiating the study, the required number of participants was determined according to the results of a pilot study which was performed by enrolling 10 patients in each group.
The time of sciatic nerve sensory block onset ± Standard Deviation (SD) was calculated as 8,88 ± 4,87 minutes for Group A (anterior approach to sciatic nerve block + femoral nerve block) and 4.70 ± 2.05 minutes for Group P (posterior approach to sciatic nerve block + femoral nerve block). The sample size was calculated on websites named www.power and www.sample size.com/Calculators/Compare-2-means/2-Sample-Equality. The sample size was calculated as 25 (n = 25) for Group A and 7 (n = 7) for Group P, while α = 5% with 85% power. Whereas, 20 patients were enrolled for Group P because small n should be greater than half of large n for reliability.
The patient's age, gender, height, weight, other existing diseases, drug use, smoking history, anesthetic method applied, operation time, tourniquet time, ASA classification, intraoperative first fentanyl requirement time and total fentanyl amount during the operation, measurements of systolic, diastolic and mean blood pressures, heart rate and peripheral oxygen saturation values before and after the block, motor and sensory block start and end times after sciatic and femoral block were performed, first Diclofenac sodium time and total Diclofenac sodium amount administered in 24 hours, visual analogue scale (VAS) values, patient satisfaction, anesthetic quality from the point of anesthesiologist, and surgical quality from the point of surgeon were recorded.
Patients who were informed about VAS one day before and not administered premedication were taken to the regional block room and routine electrocardiogram, noninvasive arterial blood pressure and peripheral pulse oximeter monitoring were performed. Baseline values of blood pressure, heart rate and peripheral oxygen saturation were recorded before the block was performed. During the operation these values were recorded every 5 minutes.
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
- None
盲法说明
A single blinded anesthesiologist performed posterior or anterior sciatic nerve block and femoral block and left the operating room 'after the nerve block was completed.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who were between the ages of 18 to 65 and were going to be operated due to lateral and/or medial malleolus fracture.
排除标准
- 未提供
研究组 & 干预措施
Group A
Anterior sciatic nerve block
干预措施: Anterior sciatic nerve block (Procedure)
Group P
Posterior sciatic nerve block
干预措施: Posterior sciatic nerve block (Procedure)
结局指标
主要结局
Comparison of sensorial block start time after sciatic nerve block performed with anterior and posterior approaches.
时间窗: up to 20 minutes.
Sensory block was assessed with a cold application every minute, and the block start time was recorded. When the patient was not receiving any stimulation with cold application on sciatic stimulation area, it was recorded as the start time of the full sciatic sensory block.
次要结局
- Comparison of sensorial block start time after femoral nerve block performed with anterior and posterior approaches.(up to 20 minutes.)
- Comparison of sensorial block end time after sciatic nerve block performed with anterior and posterior approaches.(up to 300 minutes.)
- Comparison of anesthesia quality in groups(After surgery up to 24 hours.)
- Comparison of motor block start time after sciatic nerve block performed with anterior and posterior approaches.(every minute up to 20 minutes.)
- Comparison of motor block end time after sciatic nerve block performed with anterior and posterior approaches.(every minute up to 160 minutes.)
- Comparison of motor block start time after femoral nerve block performed with anterior and posterior approaches.(every minute up to 20 minutes.)
- Comparison of sensorial block end time after femoral nerve block performed with anterior and posterior approaches.(up to 160 minutes.)
- Comparison of patient satisfaction(After surgery up to 24 hours.)
- Comparison of surgical quality in groups(After surgery up to 24 hours.)
- Comparison of intra-operatively administered first fentanyl requirement time and first diclofenac sodium requirement times in the postoperative first 24-hour periods in the groups.(within 24 hours of the post-operative period)
- Comparison of intra-operatively administered total fentanyl amount and total diclofenac sodium amount in the postoperative first 24-hour periods in the group.(within 24 hours of the post-operative period)
- Comparison of motor block end time after femoral nerve block performed with anterior and posterior approaches.(every minute up to 110 minutes.)
研究者
Abdulkadir Yektas
Principal Investigator
Bagcilar Training and Research Hospital