| 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
|
|
|
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
|
|
|
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. |