"The Anatolian Sitting Neuraxial Position Technique"; is it Beneficial? A Prospective Clinical Comparison Trial Via Ultrasonography
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Subcutaneous tissue (ST) measurements in the ASP
研究概览
简要总结
A prosperous neuraxial anesthesia positioning ensures a raised chance of successful needle placement. The primary aim is to compare "The Anatolian sitting position-ASP" with "The Sitting Fetal Position-SFP" sonographically. Secondary aim is to compare their comfort.
详细描述
Fifty participants were included to this prospective, randomized, consecutive controlled clinical study. Six parameters were evaluated in each position; subcutaneous tissue (ST), skin to spinous process (S-SP), transverse diameters of bilateral paraspinal muscles (left paraspinal muscle [LPM] and right paraspinal muscle [RPM]), interspinous gap opening (ISGO), mean of bilateral paraspinal muscles (MPM). The change of every measurement recorded via ultrasonography (USG) according to the positioning techniques (the Anatolian Sitting Position [ASP] could also be named as "sitting fetal cross-legged position" and the Sitting Fetal Position [SFP] which is a traditional sitting position) were also calculated. The calculations are explained briefly in primary outcomes (including the change of ASP-SFP in ST, S-SP, LPM, RPM, MPM, ISGO). Stretcher comfort (SC), position comfort (PC), lumbar comfort (LC), and abdominal comfort (AC) were evaluated by the participants with the 5-point Numerical Rating Scale (NRS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
The ultrasonography was made by a consultant radiologist (M.D.) Although the consultant didn't know which position was for control and which was the one the study evaluates. Although investigators were trying to mask the outcomes assessor; the consultant saw the positions because there is no way to hide the sitting positions of the participants. So there is a paradox if the consultant is masked or not.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healty and adult volunteers,
- •must be able to do the sitting fetal cross-legged position ( ASP ),
- •must be able to do the sitting fetal position ( SFP ).
排除标准
- •BMI higher than 40,
- •Lumbar hernia,
- •Scoliosis,
- •History of spine surgery,
- •History of trauma,
- •History of lower back pain,
- •Arthropathy {especially pelvic or knee problems},
- •Could not be able to do one or both of the two neuraxial position techniques.
研究组 & 干预措施
The SFP technique
In the SFP neuraxial positioning technique, fifty participants were planned to sit on the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist with legs hanging freely, forearms on the lap and hand are on the knees. The position is completed with the back curved in the fetal position. Then the USG is performed by the consultant Radiology M.D. in maximum 2 hours time to each participant, and the 5-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 24 weeks.
干预措施: The SFP technique (Procedure)
The ASP technique
In the ASP neuraxial positioning technique, the same fifty participants were planned to sit on the same part of the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist with legs crossed, forearms of the participants are on the lap and hands are on the knees, and the position is completed with the back curved in the fetal position.Then the USG is performed by the consultant Radiology M.D. in maximum 2 hours time to each participant, and the 5-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 24 weeks.
干预措施: The ASP technique (Procedure)
结局指标
主要结局
Subcutaneous tissue (ST) measurements in the ASP
时间窗: For the ASP technique, ST measurement is planned to be done in between 40mins. and 50mins. time, for each participant, through study completion.
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the ASP
Interspinous gap opening (ISGO) measurement in the ASP
时间窗: For the ASP technique, ISGO is measured in the first 10 minutes(mins.) time, for each participant, through study completion.
the wideness measurement of the ISGO in millimeters via ultrasonography (USG) in the ASP
Left paraspinal muscle (LPM) measurements in the ASP
时间窗: For the ASP technique, LPM is measured in between 10mins. and 20mins. time, for each participant, through study completion.
the diameter measurement of the LPM in millimeters via ultrasonography in the ASP
Right paraspinal muscle (RPM) measurements in the ASP
时间窗: For the ASP technique, RPM is measured in between 20mins. and 30mins. time, for each participant, through study completion.
the diameter measurement of the RPM in millimeters via ultrasonography in the ASP
The skin to spinous process (S-SP) measurements in the ASP
时间窗: For the ASP technique, S-SP measurement is planned to be done in between 50mins. and 1 hour(hr.) time, for each participant, through study completion.
the depth measurement of the skin to spinous process in millimeters via ultrasonography in the ASP
Interspinous gap opening (ISGO) measurement in the SFP
时间窗: For the SFP technique, ISGO measurement is planned to be done, right after NRS evaluation of the ASP, in between 1hr.10mins. and 1hr.20mins. time, for each participant, through study completion.
the wideness measurement of the ISGO in millimeters via ultrasonography in the SFP
The mean of bilateral paraspinal muscles (MPM) in the ASP
时间窗: For the ASP technique, MPM measurement is planned to be done in between 30mins. and 40mins. time, for each participant, through study completion.
Measured by ( \[LPM+RPM\]/2) in millimeters in the ASP
Left paraspinal muscle (LPM) measurements in the SFP
时间窗: For the SFP technique, LPM measurement is planned to be done in between 1hr.20mins. and 1hr.30mins. time, for each participant, through study completion.
the diameter measurement of the LPM in millimeters via ultrasonography in the SFP
the change of RPM (RPM ASP-SFP)
时间窗: RPM in the ASP is measured in between 20mins. and 30mins. time, and RPM in the SFP is measured in between 1hr.30mins. and 1hr.40mins. time, through study completion.
Measured by calculation (\[RPM in ASP in millimeters\]-\[RPM in SFP in millimeters\])
The mean of bilateral paraspinal muscles (MPM) in the SFP
时间窗: For the SFP technique, MPM measurement is planned to be done in between 1hr.40mins. and 1hr.50mins. time, for each participant, through study completion.
Measured by ( \[LPM+RPM\]/2) in millimeters in the SFP
Subcutaneous tissue (ST) measurements in the SFP
时间窗: For the SFP technique, ST measurement is planned to be done in between 1hr.50mins. and 2hrs. time, for each participant, through study completion.
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the SFP
The skin to spinous process (S-SP) measurements in the SFP
时间窗: For the SFP technique, S-SP measurement is planned to be done in between 2hrs. and 2hr.10mins. time, for each participant, through study completion.
the depth measurement of the skin to spinous process in millimeters via ultrasonography in the SFP
the change of ISGO (ISGO ASP-SFP)
时间窗: ISGO in the ASP is measured in the first 10mins., and ISGO in the SFP is measured in between 1hr.10 mins. and 1hr.20mins. time, through study completion.
Measured by calculation; (\[ISGO in the ASP in millimeters\]-\[ISGO in the SFP in millimeters\])
Right paraspinal muscle (RPM) measurements in the SFP
时间窗: For the SFP technique, RPM measurement is planned to be done in between 1hr.30mins. and 1hr.40mins. time, for each participant, through study completion.
the diameter measurement of the RPM in millimeters via ultrasonography in the SFP
the change of LPM (LPM ASP-SFP)
时间窗: LPM in the ASP is measured in between 10mins. and 20mins. time, and LPM in the SFP is measured in between 1hr.20mins and 1hr.30mins. time, through study completion.
Measured by calculation; (\[LPM in ASP in millimeters\]-\[LPM in SFP in millimeters\])
the change of MPM (MPM ASP-SFP)
时间窗: MPM in the ASP is measured in between 30mins. and 40mins. time, and MPM in the SFP is measured in between 1hr.40mins and 1hr.50mins. time, through study completion.
Measured by calculation (\[MPM in ASP in millimeters\]-\[MPM in SFP in millimeters\])
the change of ST (ST ASP-SFP)
时间窗: ST in the ASP is measured in between 40mins. and 50mins. time, and in the SFP is measured in between 1hr.50mins and 2hrs. time, through study completion.
Measured by calculation (\[ST in ASP in millimeters\]-\[ST in SFP in millimeters\])
the change of S-SP (S-SP ASP-SFP)
时间窗: S-SP in the ASP is measured in between 50mins. and 1hr. time, and S-SP in the SFP is measured in between 2 hrs. and 2hrs.10mins. time, through study completion.
Measured by calculation (\[S-SP in ASP in millimeters\]-\[S-SP in SFP in millimeters\])
次要结局
- Comfort evaluation in the ASP via 5-point numerical rating scale (NRS)(NRS measurement is planned to be done right after the ASP position in between 1hr. and 1hr.10mins. time, for each participant, through study completion.)
- Comfort evaluation in the SFP via 5-point numerical rating scale (NRS)(NRS measurement is planned to be done right after the SFP position in between 2hrs.10mins. and 2hrs.20mins. time, for each participant, through study completion.)
研究者
Fatma Ferda Kartufan
Assistant Professor
Yeditepe University