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CTRI Number  CTRI/2025/04/085160 [Registered on: 21/04/2025] Trial Registered Prospectively
Last Modified On: 17/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Spinal anaesthesia in four different sitting positions  
Scientific Title of Study   An observational study to identify the intervertebral space for the ease of spinal anaesthesia in four different sitting positions  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Y Sandhya Rani 
Designation  Junior Resident in Department of Anaesthesiology  
Affiliation  Hamidia Hospital, Gandhi Medical College  
Address  Operation theatre, 2nd floor ,Department of Anaesthesiology ,Hamidia hospital,Gandhi medical college, Bhopal,Madhya pradesh

Bhopal
MADHYA PRADESH
462001
India 
Phone  8455017545  
Fax    
Email  sandhyayenukoti519@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Yashwant Dhawale  
Designation  Professor in Department of Anaesthesiology  
Affiliation  Hamidia Hospital, Gandhi medical college 
Address  Operation theatre, 2nd floor ,Department of Anaesthesiology ,Hamidia hospital,Gandhi medical college, Bhopal,Madhya pradesh

Bhopal
MADHYA PRADESH
462001
India 
Phone  9425667373  
Fax    
Email  yashwantdhawalegmc@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neelesh Nema 
Designation  Assistant professor in department of Anaesthesiology  
Affiliation  Hamidia hospital, Gandhi medical college  
Address  Operation theatre, 2nd floor ,Department of Anaesthesiology ,Hamidia hospital,Gandhi medical college, Bhopal,Madhya pradesh

Bhopal
MADHYA PRADESH
462001
India 
Phone  9893427372  
Fax    
Email  neeleshnema@yahoo.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Gandhi medical college,Bhopal  
 
Primary Sponsor  
Name  Department of Anaesthesiology Gandhi medical college  
Address  Second floor, block1 Gandhi medical college and hospital Bhopal,Madhya Pradesh  
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 
Dr Y Sandhya Rani   Hamidia hospital, Gandhi medical college Bhopal   Department of Anaesthesiology, Gandhi medical college and Hamidia hospital Bhopal,MP
Bhopal
MADHYA PRADESH 
8455017545

sandhyayenukoti519@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K402||Bilateral inguinal hernia, withoutobstruction or gangrene, (2) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group 18-60years of either sex, ASA grade II scheduled for lower abdominal surgeries, perineal and pelvic girdle surgeries  
 
ExclusionCriteria 
Details  Patient refusal. Localised sepsis. Raised icp. Any anatomical site abnormality. Any neurological deficit spinal stenosis myelopathy cardiac patients BMI:28 allergy to local anaesthetics Coagulopathies lumbar surgical scar  
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To identify interspinous space, reduce number of spinal needle bone contacts and number of attempts.  Perioperatively 
 
Secondary Outcome  
Outcome  TimePoints 
To determine success rates, systolic , diastolic and mean arterial pressure changes after spinal anaesthesia induction and any adverse effects. To assess motor block onset time and sensory block time along with the ease of spinal positioning   Till 50 mins after induction  
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   29/04/2025 
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="5"
Days="1" 
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  

Spinal anesthesia is a neuraxial anesthesia technique in which local anesthetic is placed directly in the intrathecal space (subarachnoid space). The subarachnoid space houses sterile cerebrospinal fluid (CSF), the clear fluid that bathes the brain and spinal cord. There are roughly about 130 to 140 mL of CSF in an adult human which continually cycles throughout the day. Approximately 500 mL of CSF gets produced daily. Spinal anaesthesia is the most commonly used  anaesthetic technique for patients undergoing surgical procedure like infra-umbilical, perineum, pelvicgirdle. Spinal anaesthesia is useful in patients where severe respiratory disease or a difficult airway increases the risk of general anaesthesia.                             

                  Patient positioning during administration of spinal anesthesia is very important. Poor positioning may cause repeated spinal needle insertions and increase the risk of back pain, post-dural puncture headache (PDPH), epidural hematoma, and neural trauma. The sitting position is frequently used for patients undergoing spinal anesthesia, especially when low lumbar and sacral levels of sensory anesthesia are needed for the surgical procedure. The most important point for performing a neuroaxial block in a sitting position is reducing lumbar lordosis, resulting in easier access to the intervertebral space; on the other hand, lumbar flexion pushes the theca sac into a more superficial position

                 It is sometimes difficult for some patients to optimally flex their hips and knees making traditional position for induction of spinal anaesthesia difficult to achieve.Hence, there are a few  different modified sitting positions for this purpose like forward bending position(hamstring stretch position),squatting position and crossed-leg sitting position.

                    The traditional sitting position (TSP) is the most common position for spinal or epidural anesthesia where the patient sits on the operating table, with both feet placed on a stool, and both hips and knees maximally flexed . Four decades ago, a new sitting position was introduced to reduce lumbar lordosis for “easier” spinal puncture; this position involved maximum extension of the knees, adduction of the hips, and forward bending. Based on this idea, modified sitting positions have been introduced for spinal or epidural anesthesia. In these positions, the patients are sat up on the operating table, but the legs remain on the table, which is different from the TSP. In the hamstring stretch position (HSP), the knees are maximally extended , whereas in the squatting position (SP), both the hips and knees are maximally flexed .Similar success rates have been reported in studies comparing TSP with modified sitting positions for epidural or spinal anesthesia.

 
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