| CTRI Number |
CTRI/2025/10/096222 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
18/10/2025 |
| 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
|
Study Comparing Ultrasound Guidance and Conventional Technique for Thoracic Epidural Anesthesia in Major Abdominal Surgeries to Assess Procedural Efficacy |
|
Scientific Title of Study
|
"Efficacy of Real Time Ultrasound-Guided
(Paramedian Cross View) Versus Conventional Landmark Technique for
Thoracic Epidural Anesthesia in Patients Undergoing Major Abdominal
Surgeries: A Prospective Randomized Trial" |
| 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 Tejas Krishna |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
All India Institute of Medical sciences-Rishikesh, Department of Anaesthesiology, Virbhadra, Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8610462938 |
| Fax |
|
| Email |
tejasckrishna@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Additional professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
All India Institute of Medical sciences-Rishikesh, Department of Anaesthesiology, Virbhadra, Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Additional professor |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
All India Institute of Medical sciences-Rishikesh, Department of Anaesthesiology, Virbhadra, Rishikesh.
Dehradun
UTTARANCHAL
249203
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
|
Source of Monetary or Material Support
|
| Only hospital resources to be used.
AIIMS Rishikesh, Virbhadra road, Rishikesh, Uttarakhand 249203 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rishikesh |
| Address |
All India Institute of Medical Sciences Rishikesh, Virbhadra road, Rishikesh, Uttarakhand 249203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Praveen Talawar |
All India Institute of medical sciences Rishikesh |
Department of Anesthesia
6th floor, A BLOCK
Dehradun
UTTARANCHAL |
9654162941
praveenrt64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional landmark guided thoracic epidural anesthesia |
Thoracic epidural analgesia is given using the conventional landmark guided technique |
| Intervention |
Ultrasound guided Thoracic epidural analgesia |
Ultrasound Guided Thoracic Epidural Anesthesia is given using the paramedian cross view |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for major abdominal surgery
Age group between 18-60 years
ASA physical status I-III
Able and willing to provide written and informed consent
|
|
| ExclusionCriteria |
| Details |
•Refusal to give consent
•Lack of ability to cooperate or comprehend the study protocol
•Inability to maintain follow up or assess outcomes
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the first-pass success rate of real-time ultrasound-guided MTE catheter placement using the paramedian cross (PX) view as compared to conventional landmark technique in patients undergoing major abdominal surgery. |
The primary outcome will be assessed immediately at the end of the procedure after successful catheter placement |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare additional procedural parameters including - time for preparation, Time for insertion, Number of attempts, Number of needle redirections, Requirement for change of intervertebral space. Incidence of complications such as dural puncture, intravascular placement, catheter displacement, Postoperative outcomes including back pain and
Overall success rate
|
All secondary outcomes will be measured at the time of procedure, except postoperative back pain which will be assessed at 24hrs. |
|
|
Target Sample Size
|
Total Sample Size="82"
Sample Size from India="82"
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
|
N/A |
|
Date of First Enrollment (India)
|
03/11/2025 |
| 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="6"
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
|
Patients will be divided into 2 groups. Both groups will undergo thoracic epidural anaesthesia using the saline infusion loss of resistance technique. Group I: Thoracic epidural anaesthesia using real time ultrasound guided technique in paramedian cross view. Group II: Thoracic epidural anaesthesia in the conventional landmark technique using the paramedian approach. All the USG epidural catheter placements will be performed inside the operating room (OR). Upon arrival in the OR, standard American Society of Anesthesiology (ASA) monitoring will be initiated
|