| CTRI Number |
CTRI/2024/11/077442 [Registered on: 27/11/2024] Trial Registered Prospectively |
| Last Modified On: |
27/11/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing epidural 0.125 percent bupivacaine infusion alone versus with 2 mcg per ml fentanyl for postoperative pain relief in abdominal surgeries under general anaesthesia |
|
Scientific Title of Study
|
A comparative study of epidural 0.125 percent Bupivacaine infusion versus combination of epidural Bupivacaine 0.125 percent with 2 mcg per ml Fentanyl infusion for post operative pain relief in abdominal surgeries under general anaesthesia. |
| 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 Paran Gupta |
| Designation |
Post graduate resident |
| Affiliation |
Varun arjun medical college and rohilkhand hospital |
| Address |
Department of anaesthesia varun arjun medical college and rohilkhand hospital lucknow road banthara district shahjahanpur Shahjahanpur
UTTAR PRADESH
242307 India
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
8875084975 |
| Fax |
|
| Email |
guptaparan1998@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bashir Ahmad Mir |
| Designation |
Professor |
| Affiliation |
Varun arjun medical college and rohilkhand hospital |
| Address |
Department of anaesthesia varun arjun medical college and rohilkhand hospital lucknow road banthara district shahjahanpur Shahjahanpur
UTTAR PRADESH
242307 India
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9682536855 |
| Fax |
|
| Email |
mirbashir96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Arushi Saxena |
| Designation |
Assistant Professor |
| Affiliation |
Varun arjun medical college and rohilkhand hospital |
| Address |
Department of anaesthesia varun arjun medical college and rohilkhand hospital lucknow road banthara district shahjahanpur Shahjahanpur
UTTAR PRADESH
242307 India
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7253879849 |
| Fax |
|
| Email |
arushi.dr.1702@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun arjun medical college and rohilkhand hospital lucknow road banthara district shahjahanpur. Uttar pradesh (India) Pin code- 242307 |
|
|
Primary Sponsor
|
| Name |
Dr Paran Gupta |
| Address |
room no. 1004 department of anaesthesia first floor varun arjun medical college and rohilkhand hospital lucknow road banthara. district shahjahanpur Uttar pradesh, India Pin code- 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 Paran Gupta |
Rohilkhand hospital banthara shahjahanpur |
Department of anaesthesia varun arjun medical college banthara district shahjahanpur Uttar pradesh India Shahjahanpur
UTTAR PRADESH
Shahjahanpur
UTTAR PRADESH |
8875084975
guptaparan1998@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Varun Arjun Medical College & Rohilkhand Hospital NH-24 Banthara shahjahanpur Uttar Pradesh 242307 India |
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 0.125% bupivacaine infusion |
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 bupivacaine 0.125% with 2 mcg/ml fentanyl infusion |
Patients will receive an initial bolus of 8 ml of epidural analgesia infusion using 0.125% bupivacaine with 2 mcg/ml fentanyl of 5 ml per hour. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologists ASA grade I and II
Patients who gave written informed consent
Patients who are suitable for epidural analgesia based on preoperative assessment including coagulation profile evaluation and absence of contraindications to regional anaesthesia techniques
Patients who are able to communicate effectively and provide reliable feedback regarding pain intensity and any adverse effects experienced during the study period
Weight : 50 - 70 kg, Height : 150 - 180 cm, BMI : 20 - 30 kg/m2.
|
|
| ExclusionCriteria |
| Details |
Patients younger than 18 years old.
Patient not willing .
Infection at the site of block.
Patients with known allergy to local anaesthetics (such as bupivacaine) or opioids (such as fentanyl), or those with a history of adverse reactions to these medications.
Patients with coagulation disorders or those receiving anticoagulant therapy.
Patients with abnormal psychological profile on drugs like antileptic & other drugs acting on CNS .
Patient with pre-existing neurological disorders (e.g., neuropathy, myopathy) that may affect the assessment of pain or increase the risk of neurological complications related to epidural analgesia.
Patients who are unable to provide informed consent
Patient who take analgesics for last 48 hours.
Patient having chronic pain at the site of injection
Base line blood pressure less than 100/60 mmHg
|
|
|
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% infusion and combination of epidural bupivacaine 0.125% with 2 mcg/ml fentanyl infusion |
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)
|
11/12/2024 |
| 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 0.125% Bupivacaine infusion V/S Combination of Epidural Bupivacaine 0.125% with 2 mcg/ml Fentanyl Infusion for Post operative Pain relief in abdominal surgeries under General anaesthesia" 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 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 B : Patients in this group will receive a 0.125% Bupivacaine infusion in the post-operative recovery room Group BF : Patients in this group will receive a 0.125% Bupivacaine + 2 mcg/ml Fentanyl infusion infusion in the post-operative recovery room G. Patient Monitoring : SBP, DBP, 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 hypotension, nausea , vomiting and motor blockade and other side effects will be recorded |