| CTRI Number |
CTRI/2025/06/089761 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Optimal Angles of Needle Entry in Lower Thoracic Vertebrae for Thoracic Epidural by Paramedian Approach – A Pilot Study |
|
Scientific Title of Study
|
Determination of Optimal Angles of Entry at Three Lowest Thoracic Vertebrae Using Fixed Distance from Midline for Performance of Thoracic Epidurals by Paramedian Approach with Landmark Technique – A Comparative Pilot 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 Madhav Aghi |
| Designation |
Post Graduate Resident |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and Research Sharda University Greater Noida, Gautam Budh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9728623007 |
| Fax |
|
| Email |
madhavaghi789@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashok Kumar Sethi |
| Designation |
Professor |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology
School of Medical Sciences and Research Sharda University Greater Noida
Gautam Budh Nagar
Department of Anaesthesiology
School of Medical Sciences and Research Sharda University Greater Noida
Gautam Budh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
8368116645 |
| Fax |
N/A |
| Email |
newdraksethi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhav Aghi |
| Designation |
Post Graduate Resident |
| Affiliation |
School of Medical Sciences and Research Sharda University |
| Address |
Department of Anaesthesiology School of Medical Sciences and Research Sharda University Greater Noida, Gautam Budh Nagar
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
9728623007 |
| Fax |
|
| Email |
madhavaghi789@gmail.com |
|
|
Source of Monetary or Material Support
|
| School of Medical Sciences and Research Sharda University Gautam Buddha Nagar Uttar pradesh 201306 India
|
|
|
Primary Sponsor
|
| Name |
School of Medical Sciences and Research and Sharda Hospital Greater Noida |
| Address |
School of Medical Sciences and Research Sharda University Gautam Buddha Nagar Uttar pradesh 201306 India
|
| Type of Sponsor |
Private 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 Madhav Aghi |
School of Medical Sciences and Research |
Block 2F Department of Anaesthesiology Sharda University, Knowledge Park III, Greater Noida, Gautam Buddha Nagar, Uttar Pradesh – 201306 India
Gautam Buddha Nagar
UTTAR PRADESH |
9728623007
madhavaghi789@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee School of Medical Sciences and Research Sharda University Greater Noida |
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 |
| Intervention |
Epidural catheter in paramedian space |
1 and half cm lateral and 1 and half cm caudal |
| Comparator Agent |
Not Applicable |
Single arm study with no comparator group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective thoracic surgery requiring thoracic epidural analgesia
2. ASA Physical Status I and II
3. Patients who provide written informed consent |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Infection at site of injection
3. Coagulopathy or on anticoagulants
4. Spine deformity or prior thoracic spine surgery
5. Allergy to local anesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Angle of entry of epidural needle at T10–T12 vertebral levels using fixed midline distance |
Angle of entry of epidural needle at T10–T12 vertebral levels using fixed midline distance |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts required for successful epidural placement |
Intraoperative Assessment |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
10/07/2025 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This is a prospective observational pilot study conducted to determine the optimal angles of epidural needle entry at the three lowest thoracic vertebral levels using a fixed distance from the midline. The study uses the paramedian approach guided by landmark technique. Adult patients undergoing elective thoracic surgery will be included. The primary aim is to evaluate the angle of entry and compare the values at T10, T11, and T12 levels. Secondary outcomes include number of attempts, complications, and time taken for epidural placement.
|