| CTRI Number |
CTRI/2024/08/072249 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare two local anesthetics for epidural post operative pain management in lower limb surgeries and lower abdominal surgries |
|
Scientific Title of Study
|
A comparative study of epidural bupivacaine vs epidural ropivacaine for the relief of post operative pain in lower limb surgeries and lower abdominal surgries |
| 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 Swati Deswal |
| 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 |
9350936901 |
| Fax |
|
| Email |
swatideswal2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ravindra Nath Shukla |
| Designation |
HOD and Professor Anesthesia |
| 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 |
7080470075 |
| Fax |
|
| Email |
richanshu45@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 Swati Deswal |
| 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 Swati Deswal |
Rohilkhand Hospital ,Banthra ,Shahjahanpur |
Room No-104,first Floor,Department of Anesthesia,Varun Arjun Medical College and Rohilkhand Hospital,Lucknow Road,Banthra,242307
Shahjahanpur
UTTAR PRADESH |
9350936901
swatideswal2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,VAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural Bupivacaine 0.125% |
Patients will receive an initial bolus of 8 ml of epidural analgesia infusion using 0.125% bupivacaine of 5 ml per hour. |
| Comparator Agent |
Epidural Ropivacaine 0.1% |
Patients will receive an initial bolus of 8 ml of epidural analgesia infusion using 0.1% of Ropivacaine 5 ml per hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists ASA physical status I-II
Except Pregnant or Lactating women
Informed consent will be obtained from the patients for participating in the study
|
|
| ExclusionCriteria |
| Details |
Patients with known allergies to Local Anesthesia
Patients with contraindications to epidural anesthesia
For example infection at the injection site and coagulopathy
Patients with chronic pain conditions or on longterm opioid therapy
Patients with neurological or psychiatric conditions that may interfere with pain assessment
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Compare the post operative analgesic effect after administration of epidural bupivacaine 0.125% and ropivacaine 0.1% |
From starting of infusion till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Determine the requirement for rescue analgesia postoperatively when patient is on Epidural infusion |
From starting of infusion till 24 hours |
|
|
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)
|
05/09/2024 |
| 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="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 Study “A Comparative Study Of Epidural Bupivacaine Vs Epidural Ropivacaine For The Relief Of Post Operative Pain In Lower Limb Surgeries And Lower Abdominal Surgries†will be conducted in Department of Anesthesia ,Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur, Uttar Pradesh 242307 A. The study will be conducted on subjects undergoing Lower Limb and Lower Abdominal Surgeries presenting to PAC Room in Department of Anesthesia ,Varun Arjun Medical College and Rohilkhand Hospital, Banthra, Shahjahanpur based on Inclusion and Exclusion criterias B. All patients selected for the study will undergo datailed history taking and written informed consent C. PAC assessment D. Laboratory assessment E. Patients will be admitted one day before the surgery F. Patients will be allocated randomly into 2 groups Group A : Patients in this group will receive a 0.125% Bupivacaine infusion in the post-operative recovery room Group B : Patients in this group will receive a 0.1% Ropivacaine infusion in the post-operative recovery room G. Patient Monitoring : SBP, DBP, MAP, HR and VAS SCORE recorded at specified intervals after starting epidural infusion for the first 24 hours H. Adverse Events : Any adverse events , such as cardiac toxicity and motor blockade and other side effects , will be recorded |