| CTRI Number |
CTRI/2023/06/054076 [Registered on: 19/06/2023] Trial Registered Prospectively |
| Last Modified On: |
17/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
COMPARISON STUDY INJECTION HEAVY BUPIVACAINE 0.5% VS INJECTION HEAVY BUPIVACAINE 0.5% WITH FENTANYL IN LOWER ABDOMINAL AND LOWER LIMB SURGERIES |
|
Scientific Title of Study
|
A Comparative Study of Hyperbaric Bupivacaine (0.5%)
alone V/S Hyperbaric Bupivacaine (0.5%) with Fentanyl in spinal anaesthesia
for lower Abdominal & lower extremity surgery (surgeries) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Anurag Agarwal |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College |
| Address |
Room No 1004, 1st floor, Department of Anaesthesia, Varun Arjun Medical College & Rohilkhand Hospital
7080470075
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
9720704175 |
| Fax |
|
| Email |
aagarwal74@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R N Shukla |
| Designation |
Professor & HOD |
| Affiliation |
Varun Arjun Medical College |
| Address |
Room No 1002, 1st floor, Department of Anaesthesia, Varun Arjun Medical College & Rohilkhand Hospital
Shahjahanpur
UTTAR PRADESH
242307
India |
| Phone |
7080470075 |
| Fax |
|
| Email |
richanshu45@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Anurag Agarwal |
| Designation |
Post Graduate Resident |
| Affiliation |
Varun Arjun Medical College |
| Address |
Room No 1004, 1st floor, Department of Anaesthesia, Varun Arjun Medical College & Rohilkhand Hospital
UTTAR PRADESH
242307
India |
| Phone |
9720704175 |
| Fax |
|
| Email |
aagarwal74@gmail.com |
|
|
Source of Monetary or Material Support
|
| Varun Arjun Medical College & Rohilkhand Hospital Shahjahanpur Uttar Pradesh 242307 |
|
|
Primary Sponsor
|
| Name |
Anurag Agarwal |
| Address |
Varun Arjun Medical college, Banthra Shahjahanpur |
| 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 |
| Anurag Agarwal |
Varun Arjun Medical College |
Department of Anaestheology, 1st floor, Room No- 1050
Shahjahanpur
UTTAR PRADESH |
9720704175
aagarwal74@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Commitee VAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl as an additive to bupivacaine |
To determine the effects of intrathecally(route) administered fentanyl (25mcg) on hemodynamics (Blood Pressure, heart rate, duration of motor and sensory block) in spinal anaesthesia.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of age 18-60 years
2. American society of Anaesthesiologist (ASA) physical status I/II
3. Planned for elective surgery under Spinal anaesthesia. |
|
| ExclusionCriteria |
| Details |
1. Patients refusing consent
2. Patients having local sepsis at site where spinal anesthesia is to given.
3. Patients with known bleeding or coagulation disorders
4. Patients with spinal deformity
5. Patients with Cardiopulmonary diseases
6. Patients with Neurological or psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hyperbaric Bupivacaine 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 bupivacaine 0.5% alone |
Primary outcome assessed in 6 weeks |
|
|
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 bupivacine 0.5% with fentanyl as compared to patients receiving bupivacine 0.5% alone. |
Secondary outcome was assessed in 8 weeks |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
29/06/2023 |
| 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
|
Not Yet |
|
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 (Others) - nil
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response (Others) - nil
- For what types of analyses will this data be available?
Response (Others) - nil
- By what mechanism will data be made available?
Response (Others) - nil
- For how long will this data be available start date provided 01-12-2022 and end date provided 01-01-2024?
Response (Others) - nil
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The aim of the study is to compare and determine the effects of intrathecally administered 0.5% hyperbaric bupivacaine alone and 0.5% hyperbaric bupivacaine 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 & Lower Extremity Surgeries. |