| CTRI Number |
CTRI/2025/11/096954 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
04/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing pain relief of drugs like Dexmedetomidine vs Buprenorphine vs Dexamethasone in patients undergoing abdominal surgeries |
|
Scientific Title of Study
|
A double blinded randomized controlled study comparing analgesic efficacy of Dexmedetomidine versus Buprenorphine versus Dexamethasone as an adjuvant to Bupivacaine in ultrasound guided combined tranversus abdominis plane block and rectus sheath block for postoperative pain relief in patients undergoing abdominal surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manfred Francis Cardozo |
| Designation |
Junior resident Department of Anaesthesiology |
| Affiliation |
Seth V.C Gandhi and M.A Vora Municipal General Hospital |
| Address |
RMO QUARTERS, ROOM NO 706, SETH V. C. GANDHI and M. A. VORA MUNICIPAL
GENERAL HOSPITAL (RAJAWADI HOSPITAL),
NEAR POST OFFICE,
GHATKOPAR EAST MUMBAI,
Maharashtra-400077
Mumbai
MAHARASHTRA
400077
India |
| Phone |
9518700716 |
| Fax |
|
| Email |
manfredcvoss@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Reena Nebu |
| Designation |
Head of Department, Department of Anaesthesiology |
| Affiliation |
Seth V.C Gandhi and M.A Vora Municipal General Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, SETH V. C. GANDHI and M. A. VORA MUNICIPAL
GENERAL HOSPITAL (RAJAWADI HOSPITAL),
NEAR POST OFFICE,
GHATKOPAR EAST MUMBAI,
Maharashtra-400077
Mumbai
MAHARASHTRA
400077
India |
| Phone |
9820024211 |
| Fax |
|
| Email |
reenanebu@rediff.com |
|
Details of Contact Person
Public Query
|
| Name |
Manfred Francis Cardozo |
| Designation |
Junior resident Department of Anaesthesiology |
| Affiliation |
Seth V.C Gandhi and M.A Vora Municipal General Hospital |
| Address |
RMO QUARTERS, ROOM NO 706, SETH V. C. GANDHI and M. A. VORA MUNICIPAL
GENERAL HOSPITAL (RAJAWADI HOSPITAL),
NEAR POST OFFICE,
GHATKOPAR EAST MUMBAI,
Maharashtra-400077
Mumbai
MAHARASHTRA
400077
India |
| Phone |
9518700716 |
| Fax |
|
| Email |
manfredcvoss@gmail.com |
|
|
Source of Monetary or Material Support
|
| INFRASTRUCTURAL SUPPORT- Seth V.C Gandhi and M.A Vora Municipal General Hospital,Near Post Office, Ghatkopar East Mumbai Maharashtra, 400077 |
|
|
Primary Sponsor
|
| Name |
DrManfred Francis Cardozo |
| Address |
Seth V.C Gandhi and M.A Vora Municipal General Hospital |
| 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 Manfred Francis Cardozo |
Main operation theatre and wards of Seth V.C Gandhi and M.A Vora Municipal General Hospital |
SETH V. C. GANDHI and M. A. VORA MUNICIPAL
GENERAL HOSPITAL (RAJAWADI HOSPITAL),
NEAR POST OFFICE,
GHATKOPAR EAST MUMBAI,
Maharashtra-400077
Mumbai
MAHARASHTRA |
9518700716
manfredcvoss@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| HBT MEDICAL COLLEGE AND DR RN COOPER INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K819||Cholecystitis, unspecified, (2) ICD-10 Condition: N858||Other specified noninflammatory disorders of uterus, (3) ICD-10 Condition: K429||Umbilical hernia without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A |
Dexmedetomidine + 0.125% Bupivacaine
Using 1 microgam/kilogram of dexmedetomidine as an adjuvant to 0.125% concentration local bupivacaine in given combined ultrasound guided transversus abdominis plane block plus rectus sheath block |
| Comparator Agent |
Group B |
Buprenorphine + 0.125% Bupivacaine
Using 3 microgam/kilogram of buprenorphine as an adjuvant to 0.125% concentration local bupivacaine in given combined ultrasound guided transversus abdominis plane block plus rectus sheath block |
| Comparator Agent |
Group C |
Dexamethasone + 0.125% Bupivacaine
Using 0.08 milligam/kilogram of dexamethasone as an adjuvant to 0.125% concentration local bupivacaine in given combined ultrasound guided transversus abdominis plane block plus rectus sheath block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA GRADE 1 and 2 patients.
Patients undergoing elective abdominal surgeries.
Patients giving written informed consent. |
|
| ExclusionCriteria |
| Details |
Age less than 18 years, Age greater than 65 years.
No genders are excluded.
Patient refusal to participate in the study.
Any contraindication to regional anaesthesia.
Patients with neurological or psychiatric problems.
Patient allergic to study drugs.
Patients with uncontrolled hypertension or bradycardia.
Patients on chronic opioid therapy and other pain medications.
ASA GRADES 3 and above. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the postoperative analgesic efficacy of dexmedetomidine versus buprenorphine versus dexamethasone in combined transversus abdominis plane block and rectus sheath block in abdominal surgeries in providing postoperative analgesia as measured by visual analogue scale and numeric rating scale at specific time intervals. |
30 minutes
2 hours
4 hours
6 hours
10 hours
16 hours
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate duration of analgesia in hours provided by each drug by assessing the time until the first dose of rescue analgesic is required postoperatively. |
30 MINUTES
2 HOURS
4 HOURS
6 HOURS
10 HOURS
16 HOURS
24 HOURS |
| To compare the total amount of rescue analgesic administered in the first 24 hours post surgery among the 3 groups. |
30 MINUTES
2 HOURS
4 HOURS
6 HOURS
10 HOURS
16 HOURS
24 HOURS |
| To assess the incidence of postoperative complications |
30 MINUTES
2 HOURS
4 HOURS
6 HOURS
10 HOURS
16 HOURS
24 HOURS |
|
|
Target Sample Size
|
Total Sample Size="87"
Sample Size from India="87"
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 3 |
|
Date of First Enrollment (India)
|
15/11/2025 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [manfredrocks@gmail.com].
- For how long will this data be available start date provided 26-01-2029 and end date provided 26-01-2034?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The main objective of this study is to compare analgesic efficacy between dexmedetomidine, buprenorphine and dexamethasone in ultrasound guided transversus abdominis plane block and rectus sheath block in providing postoperatvie analgesia to patients. As per new guidelines it is recommended to include a mode of regional anaesthesia in providing pain relief to patients wherever possible. No study has compared the 3 drugs as adjuvants. Some drugs provide a faster onset of pain relief, some drugs might start their action late but can last longer. Hence with this study we can conclude which drugs can be used for short term as well as long term pain relief. |