| CTRI Number |
CTRI/2022/04/041964 [Registered on: 20/04/2022] Trial Registered Prospectively |
| Last Modified On: |
05/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ultrasound assisted versus landmark-guided paramedian technique of spinal anaesthesia in elderly patients. |
|
Scientific Title of Study
|
A study to compare ultrasound aided and landmark guided paramedian spinal anaesthesia in elderly patients. |
| Trial Acronym |
|
|
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 Rohtak |
| 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 Rohtak |
| 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 Rishmeet Kaur |
| Designation |
PG Student |
| Affiliation |
Pt. B. D. Sharma PGIMS Rohtak |
| Address |
Dept of Anaesthesiology,
Pt. B. D. Sharma PGIMS,
Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9054700026 |
| Fax |
|
| Email |
rishnirwan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesiology,
Pt. B. D. Sharma PGIMS,
Rohtak
(Haryana) |
|
|
Primary Sponsor
|
| Name |
Dept of Anaesthesiology Pt B D Sharma PGIMS Rohtak |
| 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
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 |
Landmark-guided paramedian technique spinal anaesthesia will be perormed |
In these patients, spinal anesthesia will be performed via paramedian approach using conventional landmark palpation technique. 0.5% heavy bupivacaine will be administered into intrathecal space. |
| Intervention |
Ultrasound aided paramedian technique spinal anesthesia will be performed |
In these patients, preprocedural ultrasound scan will be performed for skin marking of entry site of spinal needle. Spinal anesthesia will be performed via paramedian approach using the skin marking site as entry point. 0.5% heavy bupivacaine will be administered into intrathecal space. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
- Elderly patients (age≥60 years) scheduled to undergoing surgery under spinal anesthesia.
- Patients with ASA physical status classification I, II, III |
|
| ExclusionCriteria |
| Details |
- Patients having contraindication to spinal anaesthesia (coagulopathy, local infection, allergy to local anesthetic).
- Patients having marked spinal deformity and history of previous spinal surgery.
- Patients having BMI≥30.
- 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 the number of needle passes (the number of forward advancements of the spinal needle in a given interspinous space, i.e., withdrawal and redirection of spinal needle without exiting the skin.) |
1. Initiation of spinal anesthesia.
2. Completion of spinal anesthetic injection. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of skin insertion attempts (the number of times the spinal needle was withdrawn from the skin and reinserted) |
1. Initiation of spinal anesthesia.
2. Completion of spinal anesthetic injection. |
| Time for identifying landmarks. |
1. Initiation of spinal anesthesia |
| Time for administering spinal anaesthesia. |
1. Initiation of spinal anesthesia
2. Completion of spinal anesthetic injection. |
| Assessment of periprocedural discomfort. |
1. Initiation of spinal anesthesia.
2. Completion of spinal anesthetic injection. |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/04/2022 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Nil |
|
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 60
patients of either sex aged ≥60 years (ASA I,II,III) posted for surgery
under spinal anaesthesia. The aim of the
study is to compare preprocedural ultrasound aided and landmark guided
paramedian spinal anaesthesia in elderly patients. In ultrasound aided group, a preprocedural ultrasound scan will be performed and skin marking for spinal entry site will be done using ultrasound scan. Spinal anesthesia will be performed via paramedian approach using the skin marking site as entry point. In landmark guided group spinal anesthesia will be performed using conventional landmark-guided paramedian technique. The primary objective of the
study is to compare the two groups with regards to number of needle passes (the
number of forward advancements of the spinal needle in a given interspinous
space, i.e., withdrawal and redirection of spinal needle without exiting the
skin). The secondary objectives are to compare the two groups with regard to number of skin insertion attempts,time for identifying landmarks,time for administering spinal anaesthesia and assessment of periprocedural discomfort.
|