| CTRI Number |
CTRI/2024/07/070848 [Registered on: 18/07/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Different Position for Performing Spinal Anaesthesia |
|
Scientific Title of Study
|
Comparison of Lateral Decubitus and Sitting Positions for Subarachnoid Block
PERFORMING SUBARACHNOID BLOCK: 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 |
Christeena Benny |
| Designation |
Postgraduate Student |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and OT Technology
K S Hegde Medical Academy
Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9019638755 |
| Fax |
|
| Email |
bennychristy919@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Sripada G Mehandale |
| Designation |
Professor and HOD |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of
Anaesthesiology
K S Hegde Medical Academy
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9448384310 |
| Fax |
|
| Email |
sripadamehandale@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Christeena Benny |
| Designation |
Postgraduate Student |
| Affiliation |
K S Hegde Medical Academy |
| Address |
Department of Anaesthesia and OT Technology
K S Hegde Medical Academy
Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9019638755 |
| Fax |
|
| Email |
bennychristy919@gmail.com |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy
Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
|
|
Primary Sponsor
|
| Name |
K S Hegde Medical Academy |
| Address |
Deralakatte Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Type of Sponsor |
Private 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 |
| Christeena Benny |
Justice K S Hegde Charitable Hospital |
Department of Anaesthesiology
Deralakatte
Mangaluru
Dakshina Kannada
KARNATAKA |
9019638755
bennychristy919@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: Z408||Encounter for other prophylactic surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All patients undergoing elective surgery under subarachnoid block. |
|
| ExclusionCriteria |
| Details |
Refusal to consent
Inability to lie down in lateral decubitus or sitting position
Difficult back
Previous spine surgery
Obese patients with BMI> 30
Contraindication for subarachnoid block |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out & compare Success rate of inducing subarachnoid block
Time taken for lumbar puncture Number of attempts & needle redirection in lateral decubitus & sitting positions.
|
intraoperative period while administering anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To find out & compare
Patient satisfaction with positioning for subarachnoid block
Performer’s satisfactions with the positioning while inducing subarachnoid block
Technician’s satisfactions in positioning the patient |
after administering anaesthesia |
To find out & compare
Patient satisfaction with positioning for subarachnoid block
Performer’s satisfactions with the positioning while inducing subarachnoid block
Technician’s satisfactions in positioning the patient |
after administering anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
30/07/2024 |
| 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="0"
Months="6"
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
|
While both lateral decubitus and sitting positions are frequently
employed, their comparative efficacy and patient satisfaction remain subject of
investigation. Therefore, we compared these two positions concerning procedural
success, duration, patient satisfaction, and healthcare provider satisfaction was
undertaken. we
hypothesized that the success rate of subarachnoid block is better in sitting position
and is better for operator but patient will be comfortable in lateral position. |