| CTRI Number |
CTRI/2024/06/069293 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing efficacy of ultrasound guided central neuraxial block with traditional landmark guided technique |
|
Scientific Title of Study
|
Comparison of Ultrasound Guided and Landmark Guided Technique of Spinal Anaesthesia A Prospective Randomised 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 |
Dr Kaushik Raghu Ramaiah Medikonda |
| Designation |
Resident doctor |
| Affiliation |
D. Y. Patil Hospital and Research centre |
| Address |
D.Y.Patil Hospital and Research centre,Room number 15, A block, 2nd floor Main OT complex, Anaesthesia department,Ayyappa temple road, Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
07090964080 |
| Fax |
|
| Email |
kaushik2420@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jayshree vaswani |
| Designation |
Head of department |
| Affiliation |
Dr D Y Patil Hospital and Research centre |
| Address |
D.Y.Patil Hospital and Research centre,Room number 15, A block, 2nd floor Main OT complex, Anaesthesia department,Ayyappa temple road, Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
09820438822 |
| Fax |
|
| Email |
jp_vaswani@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kaushik Raghu Ramaiah Medikonda |
| Designation |
Resident doctor |
| Affiliation |
Dr D Y Patil hospital and research centre |
| Address |
D.Y.Patil Hospital and Research centre,Room number 15, A block, 2nd floor Main OT complex, Anaesthesia department,Ayyappa temple road, Vidyanagar, Sector 7, Nerul, Navi Mumbai, Maharashtra 400706
Thane
MAHARASHTRA
400706
India |
| Phone |
07090964080 |
| Fax |
|
| Email |
kaushik2420@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr DY Patil school of medicine and hospital |
|
|
Primary Sponsor
|
| Name |
Dr Kaushik Raghu Ramaiah Medikonda |
| Address |
Dr DY Patil school of medicine and hospital, Ayyappa temple road, Sector 5, Nerul, Navi Mumbai |
| Type of Sponsor |
Other [Self] |
|
|
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 Kaushik Raghu Ramaiah Medikonda |
Dr DY Patil school of medicine and hospital |
Dr DY Patil school of medicine and hospital,Anaesthesia department ,2nd floor Main OT complex, Ayyappa temple road, Vidyanagar, Sector 5, Nerul, Navi Mumbai, Maharashtra
Thane
MAHARASHTRA |
7090964080
kaushik2420@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for Biomedical and Health Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: 1||Obstetrics, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Landmark guided spinal anaesthesia |
Using traditional landmark techniques to identify spinal space for administration spinal anaesthesia |
| Intervention |
Ultrasound guided Spinal anaesthesia |
Ultrasound guided examination of spinal space after giving patient optimum position in the OT for administration of spinal anaesthesia, end point of intervention being backflow of CSF through needle hub |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving consent
Patient scheduled for elective lower abdominal, lower limb surgeries under spinal anaesthesia
|
|
| ExclusionCriteria |
| Details |
Patients of pediatric age group
Patients with deranged PT/INR, coagulopathy
Patients with decompensated cardiovascular status
Local infection at site of infection
Indeterminate neurologic disease
Patients with Spine deformities
Patients with previous history of spine surgery
Lactating and pregnant patients |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare success rates at first pass between ultrasound guided spinal anaesthesia and landmark guided spinal anaesthesia |
Administration of Spinal anaesthesia at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare number of attempts for Dural puncture |
Administration of Spinal anaesthesia at baseline |
| Compare number of passes for dural puncture |
Administration of Spinal anaesthesia at baseline |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
29/06/2024 |
| 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="1"
Months="2"
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
|
Identification of subarachnoid space is traditionally achieved by landmark guided approach. Surface landmarks are useful for identification of the spinal space, but maybe difficult to palpate in obese patients and patients with edema. Sonography provides a preview of spinal anatomy, identify midline and helps in determination of spinal space. Aim of this study is to determine whether an ultrasound guided technique could reduce the number of needle passes required for successful dural puncture compared with landmark guided technique. |