| CTRI Number |
CTRI/2019/03/018052 [Registered on: 12/03/2019] Trial Registered Prospectively |
| Last Modified On: |
09/03/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study to find out how many patients develop hearing loss after getting spinal anaesthesia with different sizes and types of spinal needles. |
|
Scientific Title of Study
|
A randomized controlled double blinded study comparing the incidence of hearing loss following subarachnoid block with pencil point needle and two different sizes of Quincke’s needle
. |
| Trial Acronym |
|
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Secondary IDs if Any
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Priyadharshini |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road,
Ammapettai, Nellikuppam,
Kancheepuram 603108
Tamil Nadu, India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9894395131 |
| Fax |
|
| Email |
priyadebu93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinod Krishnagopal |
| Designation |
Professor |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road,
Ammapettai, Nellikuppam,
Kancheepuram 603108
Tamil Nadu, India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9841557566 |
| Fax |
|
| Email |
vinodkrishnagopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Priyadharshini |
| Designation |
Post graduate |
| Affiliation |
Shri Sathya Sai Medical College and Research Institute |
| Address |
Department of Anaesthesiology
Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road,
Ammapettai, Nellikuppam,
Kancheepuram 603108
Tamil Nadu, India
Kancheepuram
TAMIL NADU
603108
India |
| Phone |
9894395131 |
| Fax |
|
| Email |
priyadebu93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai Medical College and Research Institute
Thiruporur Guduvanchery Main Road
Ammapettai Nellikuppam
Kancheepuram 603108
Tamil Nadu India |
|
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Primary Sponsor
|
| Name |
K Priyadharshini |
| Address |
74/81,Srinivasa nagar,
sakkottai post,
kumbakonam 612401
Thanjavur district |
| Type of Sponsor |
Other [principal investigator] |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| K Priyadharshini |
Shri Sathya Sai Medical College and Research Institute |
Surgery OT
2nd Floor Operation Theatre Complex
Thiruporur Guduvanchery main road,
Ammapettai, Nellikuppam,
Kancheepuram 603108
Kancheepuram
TAMIL NADU |
9894395131
priyadebu93@gmail.com |
| K Priyadharshini |
Shri Sathya Sai Medical College and Research Institute |
ENT Audiometry room
1st Floor ENT OPD
Thiruporur Guduvanchery main road, Ammapettai, Nellikuppam, Kancheepuram 603108
Kancheepuram
TAMIL NADU |
9894395131
priyadebu93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Human Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, (2) ICD-10 Condition: N30-N39||Other diseases of the urinary system, (3) ICD-10 Condition: K46||Unspecified abdominal hernia, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
23 gauge quinckes babcock spinal needle |
used to Inject 2.4ml of 0.5% Bupivacaine hyperbaric intrathecally once. |
| Intervention |
27 gauge pencil point spinal needle |
used to Inject 2.4ml of 0.5% Bupivacaine hyperbaric intrathecally once. |
| Intervention |
27 gauge quinckes babcock spinal needle |
used to Inject 2.4ml of 0.5% Bupivacaine hyperbaric intrathecally once. |
| Comparator Agent |
NIL |
NIL |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient posted for lower abdominal surgeries and perineal surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1. ASA III and above physical status
2. History of existing hearing disorders(otitis media, Meniere’s disease)
3. History of any hearing disorders during preanaesthestic assessment
confirmed by audiometry
4.Previously existing but undiagnosed hearing loss
5. On ototoxic medications
6. History of chronic headache,migraine,tinnitus
7. History of cardiac disease
8. History of coagulopathies
9. Emergency surgeries
10. pregnancy
11. Previous history of head injury
12. Not willing for audiometry |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| To compare the occurence of hearing loss by pure tone audiometry |
Post operative period after spinal anaesthesia |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| To find the incidence of post dural puncture headache |
Post operative period after spinal anaesthesia |
|
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Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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 |
|
Date of First Enrollment (India)
|
12/03/2019 |
| 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="6"
Days="0" |
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Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
This is a randomized controlled double blinded study to compare the occurence of hearing loss following spinal anaesthesia between two sizes of quinckes babcock needle and 27 gauge size pencil point needle among 66 patients undergoing subarachnoid block for lower abdominal and perineal surgeries. The primary outcome of this study is to compare the occurence of hearing loss by pure tone audiometry and the secondary outcome is to find the incidence of post dural puncture headache. |