FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080393 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 10/03/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Observational study 
Study Design  Other 
Public Title of Study   To estimate depth of lumbar epidural space from skin with help of Body Mass Index,length of vertebral column and abdominal circumference  
Scientific Title of Study   To evaluate which measurement is better in estimation of depth of lumbar epidural space from skin - Body Mass Index Vs ratio of length of vertebral column to abdominal circumference  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anil Parde 
Designation  Resident  
Affiliation  Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital Mumbai  
Address  G-1,Room No.101,Dept.of Anaesthesiology,Topiwala National Medical College and BYL NAIR charitable hospital mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  8793796443  
Fax    
Email  anilparde95@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Mangesh Gore  
Designation  Additional Professor  
Affiliation  Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital Mumbai  
Address  G-1,Room No 101, Dept of Anaesthesiology,Topiwala National Medical College and BYL NAIR charitable hospital mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  9223233165  
Fax    
Email  drmangeshg166@gmail.com  
 
Details of Contact Person
Public Query  
Name  Anil Parde 
Designation  Resident  
Affiliation  Topiwala National Medical College and Bai Yamunabai Laxman Nair Charitable Hospital Mumbai  
Address  G-1, Room No 101, Dept of Anaesthesiology,Topiwala National Medical College and BYL NAIR charitable hospital mumbai

Mumbai
MAHARASHTRA
400008
India 
Phone  8793796443  
Fax    
Email  anilparde95@gmail.com  
 
Source of Monetary or Material Support  
G-1, Room No 101,Dept of Anaesthesiology,Topiwala National Medical College and Bai Yamunabai Laxman Nair charitable hospital,mumbai-400008, Maharashtra,India. 
 
Primary Sponsor  
Name  Topiwala National Medical College and Bai Yamunabai Laxman Nair charitable hospital mumbai  
Address  Topiwala National Medical College and Bai Yamunabai Laxman Nair charitable hospital Dr A L Nair road mumbai 400008 
Type of Sponsor  Government medical college 
 
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 
DrAnil Parde   Topiwala National Medical College and Bai Yamunabai Laxman Nair charitable hospital mumbai   G-1, Room No 101,Dept of Anaesthesiology,Topiwala National Medical College and Bai Yamunabai Laxman Nair charitable hospital, mumbai 400008
Mumbai
MAHARASHTRA 		 8793796443

anilparde95@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee for Academic Research Projects( ECARP) PG Academic Committee, T.N. Medical College and BYL Nair ch hospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Ratio of vertebral column to abdominal circumference and body mass index  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients willing to participate in study.
ASA 1 and 2 patients.
Patients undergoing surgeries where epidural anaesthesia or analgesia indicated. 
 
ExclusionCriteria 
Details  Patient refusal.
Patient on anticoagulant therapy or deranged INR.
Patient with known contraindication to epidural catheter placement ( local infection, pathology like CNS disease including multiple sclerosis, guillane barre syndrome et cetera.) , previous spine surgery.
Patients with known allergies to local anaesthetic.
Pregnant patients.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
This study will help us to know which of the two ratios amongst BMI and ratio of length of vertebral column (C7-S1) to abdominal circumference is more accurate to predict depth of epidural space from skin.  During preanesthetic checkup body mass index, vertebral column length and abdominal circumference will be noted. On the day of surgery,depth of epidural space found on tuhoy needle will be noted during the procedure only. Therefore there will be no time point for observation. 
 
Secondary Outcome  
Outcome  TimePoints 
This study will help in better training of postgraduate residents & reduce the incidence of accidental dural puncture.  During Preanaesthetic checkup body mass index , vertebral column length & abdominal circumference will be noted. On the day of surgery, depth of epidural space found on tuhoy needle will be noted during the procedure only. Therefore there will be no time point in observation. 
 
Target Sample Size   Total Sample Size="84"
Sample Size from India="84" 
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   N/A 
Date of First Enrollment (India)   26/02/2025 
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)  Open to Recruitment 
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)  		 INTRODUCTION -
 Epidural block is one of the most commonly performed block in anaesthesia practice when it comes to lower abdominal and lower extremity surgeries.  The procedure is blind procedure,  wherein depth of epidural space is anticipated and cautiously achieved by using various techniques like loss of resistance, balloon technique et cetera. Conventionally positive meniscus sign is used to confirm epidural catheter in epidural space.
 Loss of resistance technique found sometimes difficult to teach as loss of resistance to needle and syringe after passing into spinal ligament can be found in two cases either in epidural space or paraspinal tissues. Nowadays many institutions abroad are using ultrasound machine to guide epidural space but in India where resources are not in abundance and everyone does not have ultrasound machine , this procedure is still performed as blind procedure. Usually senior anaesthesiologist who teaches students about this block , handholding for the procedure anticipates epidural space by taking into consideration the height, weight,  abdominal girth et cetera of the patient.
 Dr Emmanouil Stamatakis , Eleni Moka, Ioanna Siafaka, Erifilli Arygra, Athina Vadalouca proposed mathematical equation to anticipate depth of epidural space in greek population but this equation is little complex and cumbersome to practice on day to day basis. He mentioned height , weight,  body massage index and other parameters to be considered in this calculation. So we decided to study how it will be easier and less time consuming to place epidural catheter,  as it will not be possible to estimate the epidural space with help of mathematical equation everytime.
 In this study,  we are going to predict epidural space depth by comparing parameters like body mass index, abdominal circumference et cetera . We will estimate epidural space depth at lumbar region both with body massage index and ratio of length of vertebral column (seventh cervical  - first sacral  vertebra) to abdominal circumference . On the basis of results we get with these parameters,  we will compare which ratio gives better estimation of epidural space depth.
 Body mass index has weight as its component , but ratio of length of vertebral column to abdominal circumference does not take into consideration weight of the patient. Body mass index due its weight component tells you about obesity.  It is considered that all obese patients due to there weight have higher intra-abdominal pressure. There is direct co-relation that increased intra-abdominal pressure causes epidural space to reduce and so it may be achieved at less depth. Patients with intra-abdominal tumors or certain pathologist may not high weight, but due to pathology the pressure on epidural space may cause it to be at lower depth. In ratio of length of vertebral column to abdominal circumference weight component is absent.  So we are trying to estimate which one of them is more accurate to predict depth of epidural space. One point that we understand here is that as epidural space is potential space, it may or may not be altered due to all of the above factors. Still we will be able to evaluate the effect of contributing factors on body mass index as well as in ratio of length of vertebral column to abdominal circumference on depth of epidural space. 

AIM AND OBJECTIVES -
   AIM - Comparison between body mass index and ratio of length of vertebral column( se enth cervical  - first sacral  vertebra) to abdominal circumference in estimation of lumbar epidural space depth. 

   OBJECTIVES -
   1. Primary objective is to compare effectiveness of two different measurements in estimating of lumbar epidural space from skin.
    2.To evaluate which measurement is more practical in clinical settings for estimating lumbar epidural space depth. 
    3.Other objective is to enhance safety of procedure to place epidural catheter. 

STUDY DESIGN - It will be an observational study. 

PLACE OF STUDY  - Operation theatres of Topiwala National Medical College and Bai Yamunabai Laxman Nair charitable hospital,  mumbai.

DURATION OF STUDY - 18 months.

ETHICS - This study will be initiated after obtaining permission from institutional ethics committee and research committee.  Valid informed written consent will be taken prior to procedure. Identity of the patient will be kept confidential. 

MATERIAL AND METHODS -
  MATERIAL - 
                        1. Patients willing to participate in study. 
                        2. ASA 1 and 2 patients. 
                        3. Patients undergoing surgeries where epidural anaesthesia or analgesia is indicated.

SAMPLE SIZE -
   The review of literature does not show any studies using the ratio of length of vertebral column to abdominal circumference in estimating the depth of epidural space from skin. However there are few studies saying body mass index has a positive corelation with the depth of epidural space from skin. The sample size calculation for this study is based on the need to detect an anticipated effect size of 0.15 considering the variance of body mass index to be 0.11 using the following formula 
 Sample size (n) =  2( z1 - alpha÷2 + z1 - beta)2 × variance ÷ (effect size)2
Where alpha= 0.05 error
Beta= 95% power 
z1- alpha ÷2 = 1.96 at a 95% confidence interval
z1-beta = 0.84 at 80% power
effect size= 0.15
Variance=0.11

Inserting the values,
n=2(1.96+ 0.84)2 × 0.11÷(0.15)2
n= 2 × 7.84 × 0.11 ÷ 0.0225
n= 76.65 +7.665 (10% dropout)
n= 84.315.

Therefore the sample size of this study will be taken as approximately 84.

STATISTICAL ANALYSIS -
  Descriptive statistics will be used to summarize the demographic characteristics of the study population including mean, median, standard deviation and range for continuous Variables such as age, body mass index, ratio of length of vertebral column to abdominal circumference and depth of epidural space.
  Simple linear regression analysis will be conducted for each predictor variable ( BMI and length of vertebral column to abdominal circumference) separately against epidural space depth, followed by a multiple linear regression combining both predictors. Model performance will be assessed using the coefficient of determination (R-squared) with higher values indicating better predictive capability and the model with highest R- squared value will be considered the better predictor.
  The predictive accuracy of body mass index and ratio of length of vertebral column to abdominal circumference in estimating the depth of epidural space will be compared using appropriate statistical tests such as paired t-tests , wherein stronger associations will be indicated by higher t values.
  Statistical significance will be set at p less than 0.05 for all analyses. All statistical analysis will ne performed using appropriate software packages such as SPSS, R, SAS.

METHODOLOGY -
  1. After obtaining necessary approval and clearance for study from institutional ethics committee and research committee,  study begins with pre-anesthetic checkup which includes detailed history,  general and systemic examination,  vital parameters like heart rate,  blood pressure,  temperature , oxygen saturation. Valid informed written consent will be taken for the procedure. Prior to any intervention height in cm, weight in kg will be measured  and then  body mass index will be calculated in kg/cm2. Vertebral column length will be measured from 7th cervical vertebra to 1st sacral vertebra in sitting position without any flexion of back. Abdominal circumference in cm will be measured at the level of umbilicus during end of expiration in sitting position.  
  2. All patients will be kept nil by mouth for 8 hours. Upon arrival of patient to operating room, consent and nil by  mouth status will be checked. In operating room, preoperative vitals will be checked and noted , monitored for heart rate, non-invasive blood pressure, oxygen saturation and ECG after recording baseline values. A large bore intravenous cannula will be secured and patient will be preloaded with 10 ml/kg of ringer’s lactate solution considering fasting hours before epidural catheter placement and drug administration.
  3. Patient shall be placed in sitting position , under all aseptic precautions painting and draping will be done by anaesthesiologist. Then anaesthesiologist will perform procedure with 16/18 G tuhoy’s needle at L3-L4 interspace. Epidural space will be estimated by loss of resistance technique. The mark at which epidural space found on tuhoy’s needle will be noted. Then epidural catheter will be inserted and fixed after confirming positive meniscus sign.
 4. The mathematical equation for estimation of epidural space depth given in one of study done for the same in 2005 is as follows

       A) Formula  for predicting skin to lumbar epidural space distance in the general greek population is 
                     
                       3.307 + ( 0.00577 × age ) + ( 0.340 × gender ) + (0.02286 × weight ) + ( -0.00123 × height ) + (0.05065 × BMI ) + (0.199 × VI )
       
       B) Formula for predicting skin to lumbar epidural space distance in female population is 
    
                       8.401 + ( 0.002949 × age ) + ( 0.0748 × weight ) + ( - 0.0443 × height ) + ( - 0.0802 × BMI ) + ( 0.135 × VI ) + ( - 0.340 × PT )

     Variables - gender( female - 0, male - 1), age in years, weight in kg, height in cm, Body Mass Index (BMI) in kg/cm2 , vertebral interspace (VI) as L1-L2 = 1, L2-L3 = 2, L3- L4 = 3, population type (PT) as non- obstetric = 0, obstetric = 1 .

 The above said procedure will be done in 84 patients.  In each patient, body mass index and ratio of length of vertebral column to abdominal circumference along with mark on the tuhoy’s needle at which epidural space found will be noted. With the help of data obtained after the procedure , simple linear regression analysis will be conducted to know whether BMI or ratio of length of vertebral column ( seventh cervical vertebra - first sacral vertebra ) to abdominal circumference giving approximate estimation of epidural space depth.


 
Close