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CTRI Number  CTRI/2025/05/087018 [Registered on: 15/05/2025] Trial Registered Prospectively
Last Modified On: 05/06/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   comparing how correctly trainee doctors can find the spaces between the bones of backbone by touch and by using scan machines like ultrasound and X-ray 
Scientific Title of Study   Accuracy of identification of intervertebral spaces through manual palpation by anaesthesiology trainees and comparison with ultrasound and c arm guidance imaging; a prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bhaskarapanthula Sumana 
Designation  Junior resident 
Affiliation  Nizams institute of medical sciences  
Address  1st floor main operation theatre department of anaesthesia old building NIMS hospital Punjagutta Hyderabad
1st floor main operation theatre department of anaesthesia old building NIMS hospital Punjagutta Hyderabad
Hyderabad
TELANGANA
500082
India 
Phone  9676603498  
Fax    
Email  bsumana08@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Akhya kumar kar  
Designation  Associate Professor 
Affiliation  Nizams institute of medical sciences  
Address  1st floor main operation theatre department of anaesthesia old building NIMS hospital Punjagutta Hyderabad
1st floor main operation theatre department of anaesthesia old building NIMS hospital Punjagutta Hyderabad
Hyderabad
TELANGANA
500082
India 
Phone  8143385838  
Fax    
Email  karakshay@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bhaskarapanthula Sumana 
Designation  Junior resident 
Affiliation  Nizams institute of medical sciences  
Address  1st floor main operation theatre department of anaesthesia old building NIMS hospital Punjagutta Hyderabad
1st floor main operation theatre department of anaesthesia old building NIMS hospital Punjagutta Hyderabad
Hyderabad
TELANGANA
500082
India 
Phone  9676603498  
Fax    
Email  bsumana08@gmail.com  
 
Source of Monetary or Material Support  
NIZAMS INSTITUTE OF MEDICAL SCIENCES Punjagutta Hyderabad Telangana 500082 
 
Primary Sponsor  
Name  Nizams Institute of Medical Sciences 
Address  Nizams Institute of Medical Sciences Punjagutta Hyderabad 500082 
Type of Sponsor  Research institution and hospital 
 
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 
BHASKARAPANTHULA SUMANA  NIMS hospital  MAIN OPERATION THEATRE FIRST FLOOR OLD BUILDING NIMS HOSPITAL PUNJAGUTTA
Hyderabad
TELANGANA 
9676603498

bsumana08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
NIMS INSTITUTIONAL ETIHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: S822||Fracture of shaft of tibia, (2) ICD-10 Condition: S828||Other fractures of lower leg, (3) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients undergoing elective lower limb orthopaedic surgeries and requiring intra operative c arm imaging
2. patients belonging to ASA class I,II,III 
 
ExclusionCriteria 
Details  1. Patients refusal to participate
2. Compression spine fractures
3. History of spine surgeries
4. Spinal deformities ( eg: Scoliosis )
5. Pregnancy
6. BMI more than 35kg/m2 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine accuracy in identification of intervertebral spaces with increasing level of experience by anaesthesia trainees by palpation method and comparing with ultrasound and c arm image   Identification of L3-L4 and T9-T10 intervertebral spaces by anaesthesia trainees by palpation method with experience of 1 year, 2 years, 3 years, 4 years in 5 minutes and comparing the level with ultrasound in 5minutes and c arm image in 5 minutes. A total of 15minutes on each patient  
 
Secondary Outcome  
Outcome  TimePoints 
To determine ease of palpation with the level of expertise of anesthesiioliogy trainees  Quality of surface landmarks of the spine identified by anaesthesia trainees will be categorised as visible, felt easy, felt with difficulty and not felt  
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
Final Enrollment numbers achieved (Total)= "96"
Final Enrollment numbers achieved (India)="96" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/05/2025 
Date of Study Completion (India) 03/04/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 03/04/2026 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Completed 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

Identification of intervertebral space level is an essential step in neuraxial block. The spinal cord terminates distally as conus medullaris at the level of the lower border of L1 in adults. The ideal site for spinal anaesthesia is below conus medullaris to avoid trauma to the spinal cord. Identification of the level of intervertebral space is important to have a safe neuraxial block avoiding damage to the spinal cord. Even for epidural analgesia, we need to accurately identify the intervertebral space level. If an epidural catheter is placed at the wrong levels, it leads to inaccurate catheter threading, and surgical response cannot be prevented. 

Intervertebral spaces can be identified by palpation of landmark techniques like identifying intercristal line or tuffier’s line which corresponds to the line drawn between two iliac crests and traditionally corresponds to the level of the L4 vertebral body or L4 - L5 interspace. Inferior angle of scapula corresponds to T7 vertebral body.


The present study is conducted to identify accuracy among anaesthesiology trainees in identifying the level of intervertebral spaces by palpation in patients undergoing elective lower limb surgeries, where the identification by palpation may not be accurate, particularly in elderly patients with age-related degenerative changes of the spine and difficulty in positing due to associated osteoarthritis and fracture-related pain.  In previous studies, the accuracy in identifying intervertebral space by palpation of landmark technique by consultant anesthesiologists was found to be less when compared to ultrasound. In this study accuracy of identifying intervertebral space by palpation method by anaesthesiology residents having experience < 1 year, 1-2 years, 2-3 years, 3-4 years will be assessed and compared with ultrasound imaging and c-arm imaging to know the range of errors made by residents and if there is any difference with increasing level of experience among residents. 

After shifting the patient to the operation theatre, the patient will be instructed and placed in the sitting position and a paper scale  will be sticked with a double adhesive tape in the paramedian position. Four anesthesiology residents with experience of 1year, 2years, 3years, 4years will be asked to palpate intervertebral spaces T9 - T10 and L3 - L4 and the corresponding numbers on the paper scale will be noted in R1, R2, R3, R4 columns in the data collection sheet. The quality of surface landmarks is graded according to the overall ease with which these landmarks could be palpated (4-point scale: visible, Felt easy, Felt with difficulty, Not felt). Investigator then identifies intervertebral spaces T9 - T10 and  L3 - L4 with a curvilinear ultrasound probe and the corresponding number on the paper scale is noted in the data collection sheet. With the patients in the supine position, a c-arm image in the anteroposterior plane is taken and the intervertebral spaces  T9 - T10 and  L3 - L4 identified and the corresponding numbers on the paper scale is noted in the data  collection sheet. All the palpatory readings will be compared with ultrasound and c-arm findings  in data collection sheet. With the c-arm being the gold standard, the intervertebral levels identified by the c-arm will be taken as zero. Palpatory and ultrasound markings are compared with the level of c-arm and if it is 1 mark cranial to c-arm marking it is taken as +1, if it is at the level of c-arm marking it is taken as 0 and if it is 1 mark caudal to c-arm marking it is taken as -1. Demographic data will be  recorded in the form of age, gender, height, weight, and BMI. The data collected will be entered into an Excel sheet. Statistical analysis will be done using SPSS software. Descriptive statistical analysis will be done using mean ± standard deviation for continuous variables and categorical variables will be expressed as frequency. The kappa coefficient will be used to assess the agreement between different methods of identification of intervertebral spaces.


 
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