| CTRI Number |
CTRI/2024/11/076765 [Registered on: 13/11/2024] Trial Registered Prospectively |
| Last Modified On: |
12/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of midline and adjacent to midline approach to spinal anaesthesia assisted by ultrasound done before spinal anaesthesia in elderly patients. |
|
Scientific Title of Study
|
Comparison of preprocedural ultrasound aided midline and modified paramedian technique for spinal anaesthesia in elderly patients. |
| 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 Jatin Lal |
| Designation |
Professor |
| Affiliation |
Pt. B. D. Sharma PGIMS |
| Address |
Dept of Anaesthesiology,
Pt. B. D. Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin Lal |
| Designation |
Professor |
| Affiliation |
Pt. B. D. Sharma PGIMS |
| Address |
Dept of Anaesthesiology,
Pt. B. D. Sharma PGIMS, Rohtak
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajdeep Yadav |
| Designation |
Junior Resident |
| Affiliation |
Pt. B. D. Sharma PGIMS |
| Address |
Dept of Anaesthesiology,
Pt. B. D. Sharma PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8447504715 |
| Fax |
|
| Email |
raj.cool294@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesiology,
Pt. B. D. Sharma PGIMS,
Rohtak 124001,
Haryana, India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
Pt. B. D. Sharma PGIMS,
Rohtak 124001 Haryana |
| 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 Jatin Lal |
Pt. B. D. Sharma PGIMS |
Department of Anaesthesiology,
New Modular OT Complex,
Rohtak 124001
Rohtak
HARYANA |
9728265511
dr.jatinlal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound aided Midline technique |
In these patients, preprocedural ultrasound scan will be performed for skin marking of entry site of spinal needle. Spinal anesthesia will be performed via midline approach using the skin marking site as entry point. 0.5% heavy bupivacaine will be administered into intrathecal space.The duration will be from start of preprocedural ultrasound till the completion of spinal anaesthetic injection. |
| Intervention |
Ultrasound aided Modified Paramedian technique. |
In these patients, preprocedural ultrasound scan will be performed for skin marking of entry site of spinal needle. Spinal anesthesia will be performed via modified paramedian approach using the skin marking site (0.5 cm lateral on the right of midline) as entry point. 0.5% heavy bupivacaine will be administered into intrathecal space. The duration of the intervention will be from start of preprocedural ultrasound till the completion of spinal anaesthetic injection. |
|
|
Inclusion Criteria
|
| Age From |
65.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age 65 - 90 years.
2. Patients with ASA physical status classification I, II and III.
3. Patients scheduled to undergo surgery under spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients having contraindication to spinal anaesthesia (coagulopathy, local infection, allergy to local anesthetic).
2. Patients having marked spinal deformity.
3. Patients having history of previous spinal surgery.
4. Patients having BMI≥30.
5. Patients unwilling to participate. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the two groups with regards to first attempt success rate for subarachnoid block. |
At the time of completion of spinal anaesthetic injection. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of needle passes |
At the time of Completion of spinal anaesthetic injection. |
| Number of skin insertion attempts |
At the time of Completion of spinal anaesthetic injection. |
| Time for identifying ultrasound aided landmarks |
1. Time at start of identification of Ultrasound aided landmarks.
2. Time at the completion of identification of ultrasound aided landmarks. |
| Time for administering spinal anaesthesia |
1. Time at initiation of spinal anesthesia.
2. Time at completion of spinal anaesthetic injection. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
23/11/2024 |
| Date of Study Completion (India) |
16/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The present study will be conducted in the Department of Anaesthesiology and Critical care, Pt B. D. Sharma, PGIMS, Rohtak, in 80 patients of either sex aged ≥65 years (ASA I,II,III) posted for surgery under spinal anaesthesia. The aim of the study is to compare preprocedural ultrasound aided midline and modified paramedian approach to subarachnoid block in elderly patients. A preprocedural ultrasound scan will be performed and skin marking for spinal entry site will be done using ultrasound scan. Spinal anaesthesia will be performed via midline and modified paramedian (needle insertion point will be 0.5 cm lateral to the right of midline) approach using the skin marking site as entry point. The primary objective of the study is to compare the two groups with regards to first attempt success rate for subarachnoid block. The secondary objectives are to compare the two groups with regard to number of needle passes & skin insertion attempts, time for identifying ultrasound aided landmarks and time for administering spinal anaesthesia. |