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CTRI Number  CTRI/2025/03/082726 [Registered on: 19/03/2025] Trial Registered Prospectively
Last Modified On: 25/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Examining and comparing the backbone using ultrasound machine in sitting and crossed leg sitting positions undergoing surgeries below bellybutton before giving spinal anesthesia  
Scientific Title of Study   Pre-spinal assessment of spine anatomy with ultrasonography in classical sitting v/s crossed leg sitting position in patients undergoing below umbilical surgeries. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Chethana Shree A R 
Designation  First year post graduate student 
Affiliation  Navodaya Medical College, Hospital and Research Centre  
Address  Department of Anesthesiology Navodaya Medical College, Hospital and Research Centre Raichur- 584103 Karnataka

Raichur
KARNATAKA
584103
India 
Phone  9742196633  
Fax    
Email  chethanashree06@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Devanand B 
Designation  Professor 
Affiliation  Navodaya Medical College, Hospital and Research Centre  
Address  Department of Anesthesiology Navodaya Medical College, Hospital and Research Centre Raichur- 584103 Karnataka

Raichur
KARNATAKA
584103
India 
Phone  9845233239  
Fax    
Email  dr.devanand.b@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Devanand B 
Designation  Professor 
Affiliation  Navodaya Medical College, Hospital and Research Centre  
Address  Department of Anesthesiology Navodaya Medical College, Hospital and Research Centre Raichur- 584103 Karnataka

Raichur
KARNATAKA
584103
India 
Phone  9845233239  
Fax    
Email  dr.devanand.b@gmail.com  
 
Source of Monetary or Material Support  
Navodaya Medical College, Hospital and Research Centre, Raichur-584103 
 
Primary Sponsor  
Name  Chethana Shree A R 
Address  Department of Anesthesiology Navodaya Medical College, Hospital and Research Centre Raichur- 584103 Karnataka 
Type of Sponsor  Other [[self}] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chethana Shree A R  Navodaya Medical College, Hospital and Research Centre   Operation Theatre, Department of Anesthesiology, Navodaya Medical College, Hospital and Research Centre, Raichur -584103, Karnataka
Raichur
KARNATAKA 
9742196633

chethanashree06@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL HUMAN ETHICS COMMITTEE (IHEC)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: K40-K46||Hernia, (3) ICD-10 Condition: S90-S99||Injuries to the ankle and foot, (4) ICD-10 Condition: S86||Injury of muscle, fascia and tendon at lower leg level, (5) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Assessment of Inter spinous space, Inter laminar space, Skin to ligamentum flavum distance using Ultrasonography in classical sitting position.  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 in the median sagittal interspinous view. In paramedian sagittal oblique plane the Interlaminar space will be measured from the upper lamina’s lower border to the lower lamina’s upper border. Skin to Ligamentum Flavum distance will be measured from the skin to the outer border of the Ligamentum flavum–dura mater unit. All the measurements will be taken with the aid of a built-in caliper in Classical sitting position. 
Comparator Agent  Assessment of Inter spinous space, Inter laminar space, Skin to ligamentum flavum distance using Ultrasonography in Crossed leg sitting position.  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 in the median sagittal interspinous view. In paramedian sagittal oblique plane the Interlaminar space will be measured from the upper lamina’s lower border to the lower lamina’s upper border. Skin to Ligamentum Flavum distance will be measured from the skin to the outer border of the Ligamentum flavum–dura mater unit. All the measurements will be taken with the aid of a built-in caliper in Crossed leg sitting position. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1)Age 18 to 60 years of either genders
2)Patients belonging to ASA physical status I and II.
3)Patients undergoing elective lower abdominal and lower limb surgeries.

 
 
ExclusionCriteria 
Details  1)Patients not willing for the procedure
2)Patients with history of spine surgery.
3)Patient with lumbar hernia, scoliosis and lower back pain or trauma
4)Patient with pelvic and knee problem related to arthropathy

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare interspinous space, inter laminar space and skin to ligamanetum flavum distance in classical sitting and crossed leg sitting positions   These measurements are assessed using ultrasonography just before giving spinal anesthesia 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 1 
Date of First Enrollment (India)   29/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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.

 
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