| CTRI Number |
CTRI/2025/07/090553 [Registered on: 09/07/2025] Trial Registered Prospectively |
| Last Modified On: |
23/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
comparision of fentanyl versus dexmedetomidine in addition to ropivacaine in TAP block in laparoscopic cholecystectomy for post operative pain relief |
|
Scientific Title of Study
|
Evaluation of fentanyl vs dexmedetomidine as adjuvant with ropivacaine in USG guided transversus abdominis plane block for laparoscopic cholecystectomy on post operative analgesia a comparative study |
| 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 Lakshmi Mahajan |
| Designation |
Professor |
| Affiliation |
Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9855286122 |
| Fax |
|
| Email |
drlakshmimahajan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Navjot Singh Brar |
| Designation |
Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of General Sugery, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
9872674396 |
| Fax |
|
| Email |
drnavjotbrar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaspinder Kaur |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research
Amritsar
PUNJAB
143001
India |
| Phone |
8283830917 |
| Fax |
|
| Email |
dosanjh220794@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar, 143001 |
|
|
Primary Sponsor
|
| Name |
SGRD |
| Address |
Sri Gur Ram Das Institute of Medical Sciences and Research, Mehta Road, Vallah, Amritsar,143001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 RUCHI GUPTA |
SGRD |
OT 2 and 3, Department of Anaesthesia, Sri Guru Ram Das Institute of Medical
Sciences and Research, Amritsar, 143001
Amritsar
PUNJAB |
09814320805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical |
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 |
| Comparator Agent |
Postoperative pain |
Group A will receive 20 ml of ropivacaine 0.2% plus 1 mcg per kg of fentanyl will be diluted to 25 ml with 0.9% NS.
|
| Comparator Agent |
Postoperative Pain |
Group B will receive 20 ml of ropivacaine 0.2% plus 1 mcg per kg of Dexmedetomidine will
be diluted to 25ml with 0.9% NS.
|
| Comparator Agent |
Postoperative pain |
Group C will receive 20 ml ropivacaine 0.2% will be diluted to 25 ml with 0.9% NS. |
| Intervention |
Ultrasound guided transversus abdominis plane block |
Immediately after induction Ultrasound guided subcostal transverse abdominis plane (TAP) block will be given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I and II. |
|
| ExclusionCriteria |
| Details |
1. Acute cholecystitis.
2. Carcinoma Gall bladder
3. Hypersensitivity to study drugs
4. Pregnant females
5. Bleeding disorders
6. Opioid addicts.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia by both the drugs when used as adjuvants to
Ropivacaine given through sub coastal TAP block using VAS. |
at
0, 2, 4, 6, 12, and 24hrs after surgery.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Side effects like hypotension, bradycardia, postoperative nausea
vomiting, respiratory depression or any other complication arising during the study will
be assessed. |
till 24 hrs of surgery |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/08/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Introduction:Postoperative pain management is crucial for enhancing patient recovery and
reducing hospital stays. The Transversus Abdominis Plane (TAP) block, guided by ultrasound,
is a popular regional anesthesia technique for abdominal surgeries. Ropivacaine, a long-acting
local anesthetic, is commonly used in TAP blocks. However, the addition of adjuvant
analgesics such as Fentanyl and Dexmedetomidine may further enhance pain relief.
Aims and Objectives: This study aims to compare the analgesic efficacy of Fentanyl and
Dexmedetomidine as adjuvants to Ropivacaine in patients undergoing abdominal surgery with
an ultrasound-guided TAP block.
Methodology:A randomized, double-blind, controlled trial will be conducted with patients
scheduled for elective abdominal surgery. Participants will be randomly assigned to three
groups: Group R (Ropivacaine alone), Group RF (Ropivacaine with Fentanyl), and Group RD
(Ropivacaine with Dexmedetomidine). All patients will receive an ultrasound-guided TAP
block. Primary outcomes will include pain scores at rest and during movement, assessed at 1,
4, 8, 12, and 24 hours postoperatively using a Visual Analog Scale (VAS). Secondary
outcomes will include total opioid consumption in the first 24 hours postoperatively, incidence
of side effects, and patient satisfaction scores.
Outcome/Significance:This study will provide valuable insights into optimizing
postoperative pain management protocols for abdominal surgery. If successful, the findings
could support the use of Dexmedetomidine as a preferred adjuvant to Ropivacaine in TAP
blocks, improving patient outcomes and enhancing recovery. |