| CTRI Number |
CTRI/2022/01/039578 [Registered on: 19/01/2022] Trial Registered Prospectively |
| Last Modified On: |
19/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
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Public Title of Study
|
Comparison of skin to subarachnoid space distance as assessed by ultrasound depth in standard paramedian approach with needle insertion 1cm lateral and 1cm caudal to spine process and modified paramedian approach with entry point 1cm lateral spinal block in patients age 50 years or above |
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Scientific Title of Study
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A prospective randomized comparison of preprocedural ultrasound assisted standard paramedian and modified paramedian techniques for subarachnoid block in 50 years or above patients |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anu |
| Designation |
Junior resident |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Junior resident
Department of Anaesthesiology
Indira Gandhi Medical College Shimla
Himachal Pradesh
171001
India
Shimla HIMACHAL PRADESH 171001 India |
| Phone |
7018019065 |
| Fax |
|
| Email |
anurana1509@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr Arti Sharma |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Department of Anaesthesiology
Indira Gandhi Medical College
Shimla
Himachal Pradesh
171001
India
Shimla HIMACHAL PRADESH 171001 India |
| Phone |
9418299888 |
| Fax |
|
| Email |
aartisharma309@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr Arti Sharma |
| Designation |
Associate Professor |
| Affiliation |
Indira Gandhi Medical College Shimla |
| Address |
Department of Anaesthesiology
Indira Gandhi Medical College
Shimla
Himachal Pradesh
171001
India
Solan HIMACHAL PRADESH 171001 India |
| Phone |
9418299888 |
| Fax |
|
| Email |
aartisharma309@gmail.com |
|
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Source of Monetary or Material Support
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| Department of Anaesthesiology, IGMCH, Shimla, Himachal Pradesh |
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Primary Sponsor
|
| Name |
Dr Anu |
| Address |
Junior resident
Department of anaesthesia
IGMC Shimla |
| Type of Sponsor |
Other [Self] |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anu |
Indira Gandhi Medical College Hospital Shimla |
Department of Anaesthesia
Block c
Indira Gandhi Medical College Hospital Shimla Shimla HIMACHAL PRADESH |
7018019065
anurana1509@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee IGMC Shimla |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Preprocedural ultrasound assisted subarachnoid block in patients age 50 years or above by modified paramedian approach |
Subarachnoid block shall be given by modified paramedian approach in which needle will be insert 1cm lateral to spinous process |
| Intervention |
Preprocedural ultrasound assisted subarachnoid block in patients age 50 years or above by standard paramedian approach |
Subarachnoid block shall be given by standard paramedian approach in which needle will be insert1cm lateral and 1cm caudal to spinous process |
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Inclusion Criteria
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| Age From |
50.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients 50 year or above posted for infra umbilical surgery and willing to participate in study |
|
| ExclusionCriteria |
| Details |
Patients refusal for spinal anaesthesia or unwilling to participate in the study
Patients allergic to local anaesthetics
Local infection or scarring at the site of needle insertion
Patients with spinal deformities congenital or acquired and previous spine surgery
Any history of bleeding disorders
Any complication or adverse events during previous surgery under spinal anaesthesia
Patients with morbid obesity |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
Comparison of number of attempts in standard paramedian approach needle insertion 1cm lateral and 1cm caudal to spinous process and modified paramedian approach with entry point 1cm lateral to spinous process
|
0 minute
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Secondary Outcome
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| Outcome |
TimePoints |
1. Comparison of Preprocedural ultrasound measured depth for needle insertion for spinal anaesthesia and actual depth of needle insertion while administration of spinal anaesthesia using standard paramedian approach and modified paramedian approach
2. Comparison of first attempt success rate in both paramedian groups
3.Comparison of incidence of bloody tap in both groups
4.Comparison of incidence of paraesthesia in both groups
5.Comparison of incidence of post rural puncture headache in both groups within 24 hours postoperatively |
Baseline |
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Target Sample Size
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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" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
20/01/2022 |
| 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 |
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Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
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Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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NIL |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [anurana1509@gmail.com].
- For how long will this data be available start date provided 13-11-2023 and end date provided 29-11-2027?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
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Brief Summary
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Title of the project: A Prospective randomized comparison of preprocedural ultrasound assisted standard paramedian and modified paramedian technique of subarachnoid block in patients 50 years or above. Primary objective: 1 Comparison of number of attempts of in standard paramedian approach (needle insertion 1cm lateral and 1cm caudal to spinous process) and modified paramedian approach with entry point 1cm lateral to spinous process. 2 Comparison of preprocedural ultrasound measured depth for needle insertion for spinal anaesthesia and actual depth of needle insertion while administrations of spinal anaesthesia using standard paramedian approach and modified paramedian approach. 3 Comparison of first attempt success rate in both paramedian groups. Secondary objective: 1 Comparison of incidence of incidence of bloody tap in both groups. 2 Comparison of incidence of paraesthesia in both groups. 3 Comparison of incidence of post dural puncture headache in both groups within 24 hours postoperatively. Spinal anaesthesia is most preferred technique for elderly patients with multiple comorbidities. Directing the needle into the vertebral canal is sometimes difficult in elderly patients because of narrow interspinous and interlaminar spaces. Preprocedural ultrasound scanning of spine before spinal anaesthesia help to overcome the common limitations like multiple attempts, postdural puncture headache, bloody tap and neurological injuries. On reviewing the literature we could find that there is no consensus whether which approach is better or gold standard. There are many studies which comparing midline and paramedian approach but review of literature reveal very few or limited studies comparing preprocedural ultrasound assisted paramedian approach in elderly patients. Hence this particular study was undertaken.
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