| CTRI Number |
CTRI/2025/03/082915 [Registered on: 20/03/2025] Trial Registered Prospectively |
| Last Modified On: |
12/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare drug having pain relieving action given via regional method versus given intravenously
after block in patients undergoing lower abdominal surgeries |
|
Scientific Title of Study
|
A Comparitive Study Of Dexmeditomidate Versus Fentanyl As An Additive To Bupivacaine In Ultrasound Guided Transverse Abdominis Plane Block For Patients Undergoing Lower Abdominal Surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sakshi Gupta |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
DR.D.Y. Patil Medical College,Hospital And Research Centre,Pimpri Pune Pune |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
7007445037 |
| Fax |
|
| Email |
sakshig536@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subha Vazhakalayil Jose |
| Designation |
Professor,Department Of Anaesthesia |
| Affiliation |
DR.D.Y. Patil Medical College,Hospital And Research Centre,Pimpri Pune Pune |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9558224077 |
| Fax |
|
| Email |
dr.subhajose@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subha Vazhakalayil Jose |
| Designation |
Professor,Department Of Anaesthesia |
| Affiliation |
DR.D.Y. Patil Medical College,Hospital And Research Centre,Pimpri Pune Pune |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA
411018
India |
| Phone |
9558224077 |
| Fax |
|
| Email |
dr.subhajose@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central pharmacy,5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and
Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode - 411018 |
|
|
Primary Sponsor
|
| Name |
DrSAKSHI GUPTA |
| Address |
Department of Anaesthesia, 5th Floor, Hi-tech building, Dr. D.Y.Patil
Medical College, Hospital and Research Centre, Sant Tukaram
Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
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 SAKSHI GUPTA |
DR.D.Y. Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune |
Department of Anaesthesia,5 Floor,Hi-Tech Building DR.D.Y. Patil Medical College Hospital and Research Centre Sant Tukaram Nagar Pimpri Pune 411018 Carnation Girls Hostel , Dr D Y
Patil Medical College Pune
Pune
MAHARASHTRA
411018
India
Pune
MAHARASHTRA |
07007445037
sakshig536@gmail.coM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub- Committee |
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 |
DEXMEDITOMIDINE |
transabdominal plane block with 20ml of 0.25%
bupivacaine hydrochloride + 1ug/kg dexmedetomidine |
| Comparator Agent |
FENTANYL |
transabdominal plane block with
20ml of 0.25%
bupivacaine hydrochloride +1ug/kg fentanyl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I or II fit patients.
2. Ages between 18 and 65 years
3. Patients undergoing lower abdominal surgeries .
4. Haemodynamically stable patients with all routine investigations within normal limits without
any other co-morbidities.
5. Patients who are not on any cardiac related drugs.
6. Availability of written informed consent from concerned patient. |
|
| ExclusionCriteria |
| Details |
1. Patients not willing to participate in this study.
2. Patients with ASA physical status III and above physical status.
3. Patients less than 18 years and above 65 years of age.
4. Patients with uncontrolled systemic disorders like neurological, cardiac, metabolic, renal,
pulmonary disorders, hepatic disease with coagulation abnormalities etc.
5. Patients having local infection at the site where needle for block was to be inserted
6. Patients with bleeding or coagulation disorders.
7. Patients with known allergies to the study drugs. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the analgesic efficacy of dexmeditomidine versus fentanyl as an additive to bupivacaine in ultrasound-guided
transverse abdominis plane block in patients undergoing lower abdominal surgeries. |
After administration of the block, comparison
between the two groups of onset and duration of
sensory and motor blockade, duration ofanalgesia and time to rescue to analgesia will be assessed at baseline, after injection of study drug, at 5 mins, 10 mins, 15 mins, 30 mins and
10 mins after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the analgesic efficacy of dexmeditomidine versus fentanyl as an additive to bupivacaine in ultrasound-guided
transverse abdominis plane block in patients undergoing lower abdominal surgeries. |
Duration of analgesia will be assessed post surgery once the effects of the block decrease & time to rescue to analgesia will be assessed 2
hours after surgery & hourly until intervention is required |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/01/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a prospective, randomized,doube blinded comparative study to to compare dexmedetomidine versus fentanyl as an additive to bupivacaine in ultrasound-guided transverse abdominis plane block in patients undergoing lower abdominal surgeries.
Parameters that will be compared will be the duration of the analgesia and the post operative VAS scores and time to rescue analgesia. |