| CTRI Number |
CTRI/2023/05/052926 [Registered on: 19/05/2023] Trial Registered Prospectively |
| Last Modified On: |
07/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trail to compare opioid and opioid free anaesthesia for postoperative relief of pain in patients undergoing laproscopic urological surgery |
|
Scientific Title of Study
|
Comparison of Opioid based and Opioid free anaesthesia for postoperative analgesia in Laparoscopic Urological Surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shradha Prasad |
| Designation |
Post Graduate Resident |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive care. Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9953503730 |
| Fax |
|
| Email |
shradhaprasad3@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shipra Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive care. Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811420866 |
| Fax |
|
| Email |
Shipra.mamc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shipra Aggarwal |
| Designation |
Associate Professor |
| Affiliation |
Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi |
| Address |
Department of Anaesthesia and Intensive care. Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9811420866 |
| Fax |
|
| Email |
Shipra.mamc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
Shradha Prasad |
| Address |
Department of Anaesthesia and Intensive care. Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi |
| 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 |
| Shradha Prasad |
Vardhman Mahavir Medical College and Safdarjung Hospital |
Urology OT, Second Floor, Super Speciality Block, Vardhman Mahavir Medical College and Safdarjung Hospital, Ansari Nagar, New Delhi, 110029
New Delhi
DELHI |
9953503730
shradhaprasad3@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Vardhman Mahavir Medical College and Safdarjung Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Opioid based anaesthesia using injection Fentanyl. |
Patients undergoing urological laparoscopic surgery will be given opioid based anaesthesia for induction with Injection Fentanyl 1 mcg/kg iv over 10 minutes followed by continuous infusion of inj fentanyl 0.5 mcg/kg/hr till the end of surgery. At the end of induction and before the start of surgery bilateral TAP block will be given with 15 ml of 0.25% bupivacaine on each side under usg guidance. |
| Intervention |
Opioid free anaesthesia using injection dexmedetomidine. |
Patients undergoing urological laparoscopic surgery will be given opioid free anaesthesia for induction using injection dexmedetomidine 1 mcg/kg over 10 mins followed by continuous infusion of inj dexmedetomidine 0.5/mcg/kg/hr till the end of surgery. At the end of induction and before the start of surgery bilateral TAP block will be given with 15 ml of 0.25% bupivacaine on each side under usg guidance. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologist physical I and II planned for elective laparoscopic urological surgery. |
|
| ExclusionCriteria |
| Details |
1. Patients receiving opioids for chronic analgesic therapy.
2. Contraindications to TAP block.
3. Inability to comprehend Visual Analog Score.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Visual Analog Scale at rest |
1 hour after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Visual Analog Scale on coughing and at rest.
2.Time to first rescue analgesia and the total analgesic requirement.
3.Post Anaesthetic Discharge Scoring System (PADSS) |
1.0,2,4,6 and 24 hours
2.First 24 hour.
3.At 24 hour. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/11/2023 |
| Date of Study Completion (India) |
30/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/12/2024 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None 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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- 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 - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Shipra.mamc@gmail.com].
- For how long will this data be available start date provided 01-07-2026 and end date provided 01-07-2029?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
THIS STUDY IS A PROSPECTIVE, INTERVENTIONAL, RANDOMIZED COMPARATIVE CONTROLLED TRIAL WITH AN AIM TO COMPARE OPIOID-BASED ANAESTHESIA AND OPIOID FREE ANAESTHESIA FOR POSTOPERATIVE ANALGESIA IN PATIENTS UNDERGOING LAPAROSCPIC UROLOGICAL SURGERY. THE STUDY WILL BE DONE IN A SINGLE CENTRE IN INDIA. THE PRIMARY OUTCOME MEASURE WILL BE COMPARING THE VAS- R ( VISUAL ANALOG SCALE ON REST) 1 HOUR AFTER SURGERY IN BOTH THE GROUPS. THE SECONDARY OUTCOMES INCLUDE COMPARING BOTH GROUPS WITH REGARDS TO VAS-C AND VAS-R AT 0,2,4, 6, AND 24 HOURS; TIME TO FIRST RESCUE ANALGESIA AND TOTAL ANALGESIC REQUIREMENT IN THE FIRST 24 HOURS; AND PADS SCORE AT 24 HOURS. |