| CTRI Number |
CTRI/2023/11/060016 [Registered on: 20/11/2023] Trial Registered Prospectively |
| Last Modified On: |
27/06/2025 |
| 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
|
A study about the intraoperative effects and postoperative pain management of General Anesthesia in comparison to combined Epidural and General Anesthesia in elective Lumbar spine surgery. |
|
Scientific Title of Study
|
Comparing the effect and outcomes between General Anesthesia Vs Combined Epidural and General Anesthesia in Elective Lumbar Spine Surgery: A Randomized Control 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 Priyadharshini V |
| Designation |
Junior Resident in the Department of Anesthesiology |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE, HOSPITAL & RESEARCH CENTRE, VIJAYAPURA. |
| Address |
Department of Anaesthesiology, Third floor,
Shri B M Patil Medical College Hospital & Research Centre
Bangaramma sajjan campus,Solapur Road Vijayapura
Karnataka State
Department of Anaesthesiology,
Third floor,
Shri B M Patil Medical College Hospital & Research Centre
Bangaramma sajjan campus,Solapur Road Vijayapura
Karnataka State
Bijapur
KARNATAKA
586103
India |
| Phone |
9092149947 |
| Fax |
|
| Email |
priz1694@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijayakumar T K |
| Designation |
Professor in the Department of Anesthesiology |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE, HOSPITAL & RESEARCH CENTRE, VIJAYAPURA. |
| Address |
Department of Anaesthesiology,
Third Floor,
Shri B M Patil Medical College Hospital & Research Centre
Bangaramma sajjan campus,Solapur Road Vijayapura
Karnataka State
Department of Anaesthesiology,
Third Floor,
Shri B M Patil Medical College Hospital & Research Centre
Bangaramma sajjan campus,Solapur Road Vijayapura
Karnataka State
Bijapur
KARNATAKA
586103
India |
| Phone |
9844095250 |
| Fax |
|
| Email |
drvijay8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijayakumar T K |
| Designation |
Professor in the Department of Anesthesiology |
| Affiliation |
SHRI B M PATIL MEDICAL COLLEGE, HOSPITAL & RESEARCH CENTRE, VIJAYAPURA. |
| Address |
Department of Anaesthesiology,
Third Floor,
Shri B M Patil Medical College Hospital & Research Centre
Bangaramma sajjan campus,Solapur Road Vijayapura
Karnataka State
Department of Anaesthesiology,
Third Floor,
Shri B M Patil Medical College Hospital & Research Centre
Bangaramma sajjan campus,Solapur Road Vijayapura
Karnataka State
Bijapur
KARNATAKA
586103
India |
| Phone |
9844095250 |
| Fax |
|
| Email |
drvijay8@gmail.com |
|
|
Source of Monetary or Material Support
|
| SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
SHRI B M PATIL MEDCIAL COLLEGE HOSPITAL AND RESEARCH CENTRE, BLDE (DU) |
| Address |
Shri. B. M. Patil Medical College Hospital & Research Centre
Bangaramma sajjan campus,Solapur Road
Vijayapura-586103
Karnataka State
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 Vijaykumar T K |
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Shri. B. M. Patil Medical College Hospital & Research Centre, Bangaramma sajjan campus,Solapur Road
Vijayapura
Karnataka State
India
Bijapur
KARNATAKA |
9844095250
drvijay8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, (2) ICD-10 Condition: G55||Nerve root and plexus compressionsin diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A Randomised Control Trial conducted to study the intraoperative effects and postoperative pain management of general anaesthesia in comparison to combined epidural and general anaesthesia in elective lumbar spine surgery. |
Administering a combination of Epidural with General Anesthesia to provide adequate depth of anaesthesia and postoperative pain management. |
| Comparator Agent |
General Anesthesia versus Combined Epidural with General Anesthesia in Lumber Spine Sugery. |
observing the outcomes in intraoperative parameters and postoperative Analgesic requirement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2. In patients diagnosed with lumbar spine disease involving one or two levels. |
|
| ExclusionCriteria |
| Details |
patients refusal for consent for epidural. patients with systemic anticoagulation ailments. patients with septicemia. patients with local infection at the site of epidural. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and show the efficacy of Combined Epidural with General Anesthesia over sole General Anesthesia in variables such as Mean arterial pressure, Heart Rate, blood loss and amount of anesthetic agents used. |
Intraoperative monitoring of hemodynamic variables for every 15 minutes till the end of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain assessment & duration at which analgesic rescues were given. |
Pain assessment at 2hours, 4 hours, 6 hours, 12 hours & 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
Final Enrollment numbers achieved (Total)= "64"
Final Enrollment numbers achieved (India)="64" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/11/2023 |
| Date of Study Completion (India) |
31/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [priz1694@gmail.com].
- For how long will this data be available start date provided 10-04-2023 and end date provided 31-10-2025?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
AIM OF THE STUDY: To compare
the effect and outcomes both intraoperatively and postoperatively following the
sole general anesthesia and combined epidural/general anesthesia in Lumbar
spine disc surgeries.
PRIMARY OBJECTIVE: To
assess and show the efficacy of combined epidural and general anesthesia over
sole general anesthesia in variables such as Mean arterial blood pressure,
Heart rate, Blood loss and amount of anesthetic agents used.
METHODOLOGY: - Patients who are undergoing lumbar spine surgeries will be randomly grouped under Group ’A’ and Group ’B’. Group A being patients receiving General anesthesia and Group B being patients receiving a combined Epidural and General anesthesia.
- Group B patients will initially be given epidural single injection of 18ml
of 0.25% Bupivacaine (45mg) + 25mcg of Fentanyl (2 ml) in 18 ml of distilled
water administered either at the same or a level below the level of surgery in
the sitting position, using Epidural Tuohy 18G under strict aseptic precautions. Following epidural Group B patients will be administered General anesthesia.
|