| CTRI Number |
CTRI/2024/02/062526 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
General Anaesthesia which is given without opioids for laparoscopic Cholecystectomy surgery versus general anesthesia given with opiods to compare post-operative pain scores with Visual Analogue Scale |
|
Scientific Title of Study
|
Opioid-free anaesthesia for laparoscopic Cholecystectomy surgery -A prospective randomised study in a tertiary care hospital to compare post-operative pain scores with opioid -base technique |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nikhil Bhagat |
| Designation |
Junior Resident in Department of Anaesthesia |
| Affiliation |
Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha |
| Address |
Department of Anaaesthesiology, Main Operation Theatre Complex,Mahatma Gandhi institute of medical sciences, sevagram,wardha, Maharashtra
Wardha
MAHARASHTRA
442102
India |
| Phone |
8788272256 |
| Fax |
|
| Email |
bhagatnikhil619@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dhiraj Bhandari |
| Designation |
Professor in Department of Anaaesthesia |
| Affiliation |
Mahatma Gandhi institute of medical sciences, sevagram |
| Address |
Department of Anaaesthesiology, Main Operation Theatre Complex,Mahatma Gandhi institute of medical sciences, sevagram,wardha, Maharashtra
Wardha
MAHARASHTRA
442102
India |
| Phone |
9970195086 |
| Fax |
|
| Email |
dhirajbhandari@mgims.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Nikhil Bhagat |
| Designation |
Junior Resident in Department of Anaesthesia |
| Affiliation |
Mahatma Gandhi institute of medical sciences, sevagram,wardha |
| Address |
Department of Anaaesthesiology, Main Operation Theatre Complex,Mahatma Gandhi institute of medical sciences, sevagram,wardha, Maharashtra
Wardha
MAHARASHTRA
442102
India |
| Phone |
8788272256 |
| Fax |
|
| Email |
bhagatnikhil619@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Mahaarashtra 442102 |
|
|
Primary Sponsor
|
| Name |
Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, Maharashtra 442102 |
| Address |
Department of Anaesthesiology, Maain Operation Theatre Complex,Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha 442102 |
| Type of Sponsor |
Government 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 |
| DrNikhil Bhagat |
Kasturba Hospital, Mahatma Gandhi Institute of Medical Sciences |
Department of Anaesthesiology, Main Operation Theatre Complex, Mahatma Gandhi Institute of Medical Sciences, Sevagram Wardha, Maharashtra 442102
Wardha
MAHARASHTRA |
8788282256
bhagatnikhil619@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (2) ICD-10 Condition: K811||Chronic cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Pentazocine given intravenously as opioid analgesic for studying post operative analgesia in ASA grade 1 and ASA grade 2 patients of age group 18 to 60 years undergoing laparoscopic cholecystectomy surgery |
15 milligrams of Pentazocine given intravenously as a single dose in 5 minutes for pre operative analgesia in ASA grade 1 and ASA grade 2 patients of age group 18 to 60 years undergoing laparoscopic cholecystectomy surgery |
| Intervention |
Studying effect of erector spinae block for post operative analgesia with magnesium sulphate plus 1 percent lignocaine as blocking agents |
Single dose of 2 grams of Magnesium Sulphate plus 20 millilitres of 1 percent lignocaine infiltration given in 5 minutes as erector spinae interfascial plane block for studying its post operative analgesia in ASA grade 1 and ASA grade 2 patjents of age group 18 to 20 years undergoing elective laparoscopic cholecystectomy surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of Anaesthesiologists (ASA) physical status I/II patients.
2. Patients aged between 18-65 yr.
3. Patients with both male and female gender.
4. Duration of surgery less than 4 hrs.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Studying post operative analgesia |
Immediate post operative period,1 hour, 2 hours, 4 hours, 6 hours and 12 hours of post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative nausea and vomiting, hemodynamic stability including heart rate, blood pressure |
Immediate post operative period, 1 hour, 2 hours, 4 hours, 6 hours and 12 hours of post operative period |
|
|
Target Sample Size
|
Total Sample Size="74"
Sample Size from India="74"
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)
|
16/02/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/02/2024 |
| 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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.
- 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 - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [bhagatnikhil619@gmail.com].
- For how long will this data be available start date provided 05-02-2024 and end date provided 04-02-2026?
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
|
We are studying post operative analgesia in laparoscopic cholecystectomy surgery with erector spinae block with 2 grams of Magnesium Sulphate plus 20 millilitres of 1 percent lignocaine against 15 milligrams of Pentazocine |