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临床试验/CTRI/2025/03/082726
CTRI/2025/03/082726尚未招募1 期

Pre-spinal assessment of spine anatomy with ultrasonography in classical sitting v/s crossed leg sitting position in patients undergoing below umbilical surgeries.

Chethana Shree A R1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2025年3月29日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
90
试验地点
1
主要终点
To compare interspinous space, inter laminar space and skin to ligamanetum flavum distance in classical sitting and crossed leg sitting positions

研究概览

简要总结

The aim of the study is to and compare classical sitting and crossed leg sitting positions in patients undergoing below umbilical surgeries according to lumbar anatomical measurements calculated using ultrasonography.

A prospective, randomized clinical study will be conducted after obtaining institutional ethical committee approval, written and informed consent from the patients admitted for surgery and satisfying inclusion criteria.

The study will be conducted in 45 patients in each group between 18 to 60 years of age, ASA-I and ASA-II of either gender undergoing elective lower abdominal and lower limb surgeries. Patients will be informed about the proposed position for the procedure during the pre-anesthetic visit.

Patients will be randomly allocated into one of the following groups of 45 each patients.

Group 1-CSP – Patients in classical sitting position

Group2- CLSP - Patients in crossed leg sitting position

Randomization is done using a computer-generated random number table.

All the patients in the study will be subjected to a thorough pre-anesthetic evaluation which includes a detailed history taking, complete general physical examination and necessary relevant investigations like complete blood count, HIV, HBsAG etc.

Tab Alprazolam 0.5mg and Cap Pantoprazole 40mg are given orally at night on the day before surgery. All the patients are kept nil per oral as per standard guidelines.

Patients will be taken on the operation table and standard ASA monitors will be connected. Preoperative heart rate and systolic blood pressure, diastolic blood pressure, mean arterial pressure, respiratory rate, oxygen saturation, electrocardiogram are recorded. Intravenous line will be secured and appropriate intravenous fluid is started.

Group CSP patients are made to sit with legs extended, the forearms held on laps and hands on the knees. In Group CLSP, the patients legs are crossed, the forearms on the laps , the hands are positioned on knees.

All the examinations are done by experienced anesthesiologist. All sonographic examinations are done using USG machine (FUJIFILM SonoSite M.Turbo) or (Wipro GE/Logic C-5) after applying hydrophilic anti allergic ultrasound transmission gel.  A curved array transducer will be initially placed longitudinally over the spine in the midline to get a median sagittal spinous process view. The crescent shaped hyperechoic reflections of the spinous processes and the Inter spinous space (ISS) is identified. The transducer will be moved caudally to visualize the sacrum, and a gap seen between the sacrum and the spinous process of the L5 vertebra is L5–S1 ISS. The L4–L5 and L3–L4 ISSs will be located by counting upwards while moving the transducer in a cranial direction. Inter spinous space will be measured as the distance between the lower border of the upper spinous process and the upper border of the lower spinous process and is measured in the median sagittal interspinous view.

The transducer will be then placed in the paramedian sagittal oblique plane to visualize the L5–S1, L4–L5 and L3–L4 spaces. The L5–S1, L4–L5 and L3–L4 Inter laminar spaces will be located by counting upwards after identifying the sacrum. The interlaminar space (ILS) will be measured from the upper lamina’s lower border to the lower lamina’s upper border. Skin to Ligamentum Flavum(S-LF) distance will be measured from the skin to the outer border of the LF–dura mater unit. All the measurements will be taken with the aid of a built in caliper.

After the anatomical measurement calculations using ultra sonography, under strict aseptic precautions lumbar spinous process and interspinous spaces will be  palpated and identified in CSP and CLSP respectively. After infiltration of local anesthetic 2% lignocaine at the selected site and the Spinal needle will be introduced in the midline remaining perpendicular to the patient’s back and needle is slowly inserted, piercing the skin, subcutaneous tissue, supraspinous ligament, interspinous ligament, ligamentum flavum, dura matter, subdural space, then the arachnoid matter, into the subarachnoid space, which will be confirmed by free flow of CSF. The needle will be fixed on the patient’s back and then connected to a syringe containing the drug is deposited into intrathecal space using the 0.5% hyperbaric bupivacaine administrated through 25G Quinke Babcock Spinal needle and patient made to lie.

Ease of landmark palpation, Number of attempts for successful spinal needle placement and number of bone needle contacts are assessed.

Level and onset of the neuraxial blockade is assessed by temperature change which is detected by wetted alcohol sponge, and the level of sensory loss by ability to detect sensation of pinpricks and motor block by the Modified Bromage scale.

Modified Bromage scale:

Grade 0-able to move the hip, knee, and ankle

Grade 1- unable to move the hip but is able to move the knee and ankle

Grade 2- unable to move the hip and knee but is able to move ankle

Grade 3- unable to move the hip, knee, and ankle.

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 60.00 Year(s)(—)
性别
All

入选标准

  • Age 18 to 60 years of either genders 2)Patients belonging to ASA physical status I and II.
  • Patients undergoing elective lower abdominal and lower limb surgeries.

排除标准

  • Patients not willing for the procedure 2)Patients with history of spine surgery.
  • Patient with lumbar hernia, scoliosis and lower back pain or trauma 4)Patient with pelvic and knee problem related to arthropathy.

结局指标

主要结局

To compare interspinous space, inter laminar space and skin to ligamanetum flavum distance in classical sitting and crossed leg sitting positions

时间窗: These measurements are assessed using ultrasonography just before giving spinal anesthesia

次要结局

  • Successful spinal needle placement in one try(Assessed during spinal anesthesia)
  • Number of needle bone contacts(Assessed during spinal anesthesia)
  • Ease of landmark palpation(Assessed during spinal anesthesia)

研究者

发起方
Chethana Shree A R
申办方类型
Other [[self}]
责任方
Principal Investigator
主要研究者

Chethana Shree A R

Navodaya Medical College, Hospital and Research Centre

研究点 (1)

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