| CTRI Number |
CTRI/2022/07/044395 [Registered on: 27/07/2022] Trial Registered Prospectively |
| Last Modified On: |
23/07/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between opioid free and opioid based anaesthesia in laparoscopic surgeries |
|
Scientific Title of Study
|
Comparison between Opioid free and
Opioid based anesthesia for laparoscopic
surgeries : A prospective randomized study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Carolin Smita Kerketta |
| Designation |
Assistant Professor |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
C Block Qr no 103 GCS medical College Hospital and Research Centre, opp. DRM
office, Nr. Chamunda bridge, Naroda Road,
Anaesthesia Department, GCS medical College, Hospital and Research Centre, opp. DRM
office, Nr. Chamunda bridge, Naroda Road,
Ahmadabad
GUJARAT
380025
India |
| Phone |
9904451321 |
| Fax |
|
| Email |
carolinsmita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Carolin Smita Kerketta |
| Designation |
Assistant Professor |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
C Block Qr no 103,GCS medical College, Hospital and Research Centre, opp. DRM
office, Nr. Chamunda bridge, Naroda Road, Ahmedabad
Anaesthesia Department, GCS medical College, Hospital and Research Centre, opp. DRM
office, Nr. Chamunda bridge, Naroda Road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
9904451321 |
| Fax |
|
| Email |
carolinsmita@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Carolin Smita Kerketta |
| Designation |
Assistant Professor |
| Affiliation |
GCS Medical College, Hospital and Research Centre |
| Address |
C Block Qr no 103,GCS medical College, Hospital and Research Centre, opp. DRM
office, Nr. Chamunda bridge, Naroda Road, Ahmedabad
Anaesthesia department, GCS medical College, Hospital and Research Centre, opp. DRM
office, Nr. Chamunda bridge, Naroda Road, Ahmedabad
Ahmadabad
GUJARAT
380025
India |
| Phone |
9904451321 |
| Fax |
|
| Email |
carolinsmita@gmail.com |
|
|
Source of Monetary or Material Support
|
| GCS Medical College Hospital and Research Centre |
|
|
Primary Sponsor
|
| Name |
GCS Medical College Hospital and Research Centre |
| Address |
GCS medical College, Hospital and Research Centre, opp. DRM
office, Nr. Chamunda bridge, Naroda Road, Ahmedabad |
| 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 carolin smita kerketta |
GCS Medical College Hospital and Research Centre |
Anaesthesia Department, GCS medical College, Hospital and Research Centre, opp. DRM
office, Nr. Chamunda bridge, Naroda Road, Ahmedabad
Ahmadabad
GUJARAT |
9904451321
carolinsmita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, GCS medical college, |
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 |
Erector Spinae block with non opioids
|
: I.V Lignocaine – 1.5 mg/kg infusion
I.V Magnesium sulfate- 2 gm bolus slowly
Before extubation we will give USG guided Erector Spinae block – 0.5% Ropivacaine 30ml
|
| Comparator Agent |
opoid group
|
Fentanyl 0.5 mcg/kg as per vitals if they cross 20% of baseline intraoperatively |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I & II posted for underlying lap surgeries
Cholecystectomy
Appendicectomy
Diagnostic Lap
Who can understand & express pain
|
|
| ExclusionCriteria |
| Details |
Hepatic & renal insufficiency
Allergy to local anesthetic agent
consent refusal
asa 3 and 4
age>70 years |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the pain scores in post operative period using NRS score for 24hours |
o hour, 4 hours , 6hours, 12 hours , 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare intraoperative haemodynamic parameters
Duration of post operative analgesia
1st rescue analgesia time
Total analgesia consumed in 1st 24 hrs |
o hour, 4 hours , 6hours, 12 hours , 24 hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
01/08/2022 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
original research article |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim:
To compare opioid free anaesthesia with
opioid based technique for post operative pain relief in laparoscopic surgeries
Objectives:
•
Primary objective - To assess the pain scores in post
operative period using NRS score for
24hours.
•
Secondary Objective –
•To
compare intraoperative haemodynamic parameters
•Duration
of post operative analgesia
•1st rescue analgesia time
•Total
analgesia consumed in 1st
24 hrs
•Prospective
randomized controlled study
•
•Written
and informed consent will be obtained.
•Patients
of ASA Grade I & II posted for elective laparoscopic surgeries to be
included & randomly divided into two equal groups. •Postoperative
24 hours(0/2/4/6/12/24 hrs)
NRS : (0-10)
•Duration of analgesia
•Intra operative hemodynamic parameters
•Time to First Rescue Analgesia if NRS
>5
•Total dose of analgesic requirement post
operatively in 24hrs |