| CTRI Number |
CTRI/2024/10/075044 [Registered on: 10/10/2024] Trial Registered Prospectively |
| Last Modified On: |
21/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare two local anesthetics with opioid and without opioid in spinal anesthesia for lower abdominal and lower extremity surgeries |
|
Scientific Title of Study
|
A comparative study of hyperbaric levobupivacaine 0.5 percentage alone vs hyperbaric levobupivacaine 0.5 percentage with fentanyl in spinal anesthesia for lower abdominal and lower extremity surgeries |
| 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 Shantanu Yadav |
| Designation |
Junior Resident |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9773948196 |
| Fax |
|
| Email |
yadavshantanu86@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Kumar Bhaskar |
| Designation |
Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9837027227 |
| Fax |
|
| Email |
vkbhaskar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shivam Jaisawal |
| Designation |
Assistant Professor |
| Affiliation |
Varun Arjun Medical College and Rohilkhand Hospital |
| Address |
Department of Anesthesia Varun Arjun Medical College and Rohilkhand Hospital Lucknow Road,Banthra,Shahjahanpur
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7873657121 |
| Fax |
|
| Email |
Shivamjaiswal88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College and Rohilkhand Hospital,Lucknow
Road,Banthra,Shahjahanpur,Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Shantanu Yadav |
| Address |
Varun Arjun Medical College and Rohilkhand Hospital,Lucknow
Road,Banthra,Shahjahanpur,Uttar Pradesh,India,242307 |
| 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 Shantanu Yadav |
Rohilkhand Hospital ,Banthra ,Shahjahanpur |
Room no -1004,,Department of anaesthesia,Varun Arjun Medical College and Rohilkhand Hospital,Lucknow
Road,Banthra,Shahjahanpur,Uttar Pradesh
Shahjahanpur
UTTAR PRADESH |
9773948196
yadavshantanu86@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,Varun Arjun Medical College ,Banthra,Shahjahanpur,uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:4||Measurement and Monitoring. Ayurveda Condition: NIL, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyperbaric Levobupivacaine 0.5% |
Hyperbaric Levobupivacaine 0.5% alone in 1st group who are undergoing Lower Abdominal and Lower Extremities Surgeries |
| Comparator Agent |
Hyperbaric Levobupivacaine 0.5% with fentanyl |
Hyperbaric Levobupivacaine 0.5% with fentanyl in 2nd group who are undergoing Lower Abdominal and Lower Extremities Surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients aged 18 to 65 years scheduled for elective lower abdominal or lower extremity surgeries
2.American Society of Anaesthesiologists (ASA) physical status I or II
|
|
| ExclusionCriteria |
| Details |
1.Hypersensitivity to Local Anaesthetics or Opioids
2.Cardiac dysfunction
3.Respiratory Disease
4.Coagulation Disorders
5.Pregnancy
6.Inability to Provide Informed Consent
7.ASA Physical Status III or higher
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Hyperbaric Levoupivacaine 0.5% with Fentanyl in
Spinal Anesthesia for Lower Abdominal & Lower
Extremity Surgeries found to have longer
duration of sensory and motor blockage then
hyperbaric levobupivacaine 0.5% alone |
Primary outcome assessed in 5 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Quality of subarachnoid block, hemodynamic
stability,
perioperative analgesia in patients undergoing
for Lower
Abdominal & Lower Extremity Surgeries are
better in patients receiving levobupivacine 0.5% with
fentanyl as compared to patients receiving
levobupivacine 0.5% alone |
secondary outcome assessed in 1 hour |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/09/2025 |
| 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="0"
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
|
The aim of the study is to compare and determine the effects of intrathecally administered 0.5% hyperbaric levobupivacaine alone and 0.5% hyperbaric levobupivacaine with fentanyl (25mcg) on reduction of higher blocks incidence simultaneously assess the onset, duration of sensory and motor block, quality of subarachnoid block, hemodynamic stability, perioperative analgesia and any adverse drug reactions in patients undergoing for Lower Abdominal and Lower Extremity Surgeries. |