| CTRI Number |
CTRI/2026/02/103861 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of different patient positions for administering injection in the spine |
|
Scientific Title of Study
|
Comparison of different patient positions for neuraxial access: a randomised controlled 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 |
Shivananda N V |
| Designation |
Consultant |
| Affiliation |
Manipal Hospital Whitefield |
| Address |
1st floor, Department of Anaesthesiology, Manipal Hospital Whitefield, ITPL Main Rd, KIADB Export Promotion Industrial Area, Krishnarajapura, Bengaluru
Bangalore KARNATAKA 560066 India |
| Phone |
9686585584 |
| Fax |
|
| Email |
drnvshivanand@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Shivananda N V |
| Designation |
Consultant |
| Affiliation |
Manipal Hospital Whitefield |
| Address |
1st floor, Department of Anaesthesiology, Manipal Hospital Whitefield, ITPL Main Rd, KIADB Export Promotion Industrial Area, Krishnarajapura, Bengaluru
Bangalore KARNATAKA 560066 India |
| Phone |
9686585584 |
| Fax |
|
| Email |
drnvshivanand@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Shivananda N V |
| Designation |
Consultant |
| Affiliation |
Manipal Hospital Whitefield |
| Address |
1st floor, Department of Anaesthesiology, Manipal Hospital Whitefield, ITPL Main Rd, KIADB Export Promotion Industrial Area, Krishnarajapura, Bengaluru
Bangalore KARNATAKA 560066 India |
| Phone |
9686585584 |
| Fax |
|
| Email |
drnvshivanand@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Manipal Hospital Whitefield, Bangalore, Karnataka, India. Pincode - 560066. |
|
|
Primary Sponsor
|
| Name |
Shivananda N V |
| Address |
Manipal Hospital Whitefield
ITPL Main Rd,
KIADB Export Promotion Industrial Area, Krishnarajapura, Bengaluru, Karnataka 560066 |
| Type of Sponsor |
Other [Self] |
|
|
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 Shivananda N V |
Manipal Hospital Whitefield |
1st floor,
Department of Anaesthesiology,
ITPL Main Rd,
KIADB Export Promotion Industrial Area, Krishnarajapura,
Bengaluru Bangalore KARNATAKA |
9686585584
drnvshivanand@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of Manipal Hospitals, Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 3||Administration, (2) ICD-10 Condition: 4||Measurement and Monitoring, (3) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Sitting position while hugging a pillow |
Patients positioned for neuraxial anaesthesia in sitting position while hugging a pillow. Total duration of intervention - maximum of 30 minutes. Frequency of intervention - maximum of 3 attempts. |
| Intervention |
Sitting position with the aid of a Mayo-trolley |
Patients positioned for neuraxial anaesthesia in sitting position with the aid of a Mayo-trolley. Total duration of intervention - maximum of 30 minutes. Frequency of intervention - maximum of 3 attempts. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients receiving neuraxial anaesthesia (spinal anaesthesia)
Patient under American society of Anaesthesiologists (ASA) I - III |
|
| ExclusionCriteria |
| Details |
Patients undergoing caesarean section
Patients with previous history of lumbar spine surgeries
Patients who are allergic to local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate if the success rate of neuraxial anaesthesia is higher for patients positioned with the aid of a Mayo-trolley in sitting position when compared to patients positioned in sitting position while hugging a pillow. |
0 hour to end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate if the interlaminar space while providing neuraxial anaesthesia is larger for patients positioned with the aid of a Mayo-trolley in sitting position when compared to patients positioned in sitting position while hugging a pillow. |
0 hour to end of surgery |
| To evaluate if the time taken for providing neuraxial anaesthesia is shorter for patients positioned with the aid of a Mayo-trolley in sitting position when compared to patients positioned in sitting position while hugging a pillow. |
0 hour to end of surgery |
| To evaluate if the patient satisfaction while providing neuraxial anaesthesia is better for patients positioned with the aid of a Mayo-trolley in sitting position when compared to patients positioned in sitting position while hugging a pillow. |
0 hour to end of surgery |
| To evaluate if the anaesthetist satisfaction while providing neuraxial anaesthesia is better for patients positioned with the aid of a Mayo-trolley in sitting position when compared to patients positioned in sitting position while hugging a pillow. |
0 hour to end of surgery |
|
|
Target Sample Size
|
Total Sample Size="626" Sample Size from India="626"
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)
|
28/02/2026 |
| 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="0" 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
|
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 neuraxial 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 thecal sac into a more superficial position. There are a few studies comparing different sitting positions including a traditional sitting position (TSP), forward bending or hamstring stretch position (HSP) and squatting position (SP) for reversing the lumbar lordosis and improving access to intervertebral space for neuraxial block. However, there are very few studies which have used a mayo trolley for supporting the upper body with the legs in pendant position while administering the spinal anaesthesia. In this study, we investigate if neuraxial anaesthesia has higher success rate when patients are positioned while sitting with legs in pendant position and upper body supported with the aid of a Mayo-trolley (Mayo-trolley pendant position) to administer when compared to patients positioned in sitting position while hugging a pillow (traditional sitting position). |