CTRI Number |
CTRI/2022/01/039789 [Registered on: 28/01/2022] Trial Registered Prospectively |
Last Modified On: |
27/01/2022 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of two drug combination for Laparoscopic Cholecystectomy for post operative pain relief |
Scientific Title of Study
|
Comparison of intravenous lignocaine with intravenous lignocaine and Magnesium Sulphate combination for Laparoscopic Cholecystectomy |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Shreyas Jaiswal |
Designation |
Junior Resident |
Affiliation |
IGIMS |
Address |
Department of Anesthesia and critical care , IGMIS, Sheikpura, Patna
Patna BIHAR 800014 India |
Phone |
|
Fax |
|
Email |
shreyasbony@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Alok Kumar |
Designation |
Senior resident (SR) |
Affiliation |
IGIMS |
Address |
Department of Anesthesia and critical care , IGMIS, Sheikpura, Patna
Patna BIHAR 800014 India |
Phone |
|
Fax |
|
Email |
alok4138starex@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Alok Kumar |
Designation |
Senior resident (SR) |
Affiliation |
IGIMS |
Address |
Department of Anesthesia and critical care , IGMIS, Sheikpura, Patna
Patna BIHAR 800014 India |
Phone |
|
Fax |
|
Email |
alok4138starex@gmail.com |
|
Source of Monetary or Material Support
|
Dr Alok , department of Anesthesia and ccm , IGIMS , Sheikpura , Patna -800004 |
|
Primary Sponsor
|
Name |
Dr Alok Kumar |
Address |
Department of Anesthesia and critical care , IGIMS , Sheikpura, Patna |
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 Alok Kumar |
IGIMS , Sheikpura, Patna |
First floor , Ward Block , Department of Anesthesia and CCM , IGIMS , Sheikpura, Patna Patna BIHAR |
9028300731
alok4138starex@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethical Committee, IGIMS |
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 |
Infusion of lignocaine post operatively |
These patients will receive only intravenous lignocaine 2mg/kg in bolus in 50 ml and maintained at 3mg/kg/hour. |
Intervention |
Post op infusion of lignocaine and magnesium sulphate |
These patients will receive the combination of intravenous lignocaine and magnesium sulphate 50mg/kg in bolus of 50 ml and maintained at 15 mg/kg/hour and lignocaine at same dose. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1)Patients aged 18 to 50 years of both sex undergoing laproscopic cholecystectomy under general anesthesia.
2)ASA 1 and 2.
3)Consenting patients
|
|
ExclusionCriteria |
Details |
1)Patient refusal
2)ASA 3 & 4
3)Allergy to drugs
4)Seropositive and COVID 19 positive
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Centralized |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1)Quality of recovery score in post operative laproscopic cholecystectomy over 24 hours
2)To compare post-operative analgesia in the group with lignocaine and a group with combination of lignocaine and magnesium sulphate by NRS score at 0, 2, 4, 12 and 24 hour. |
1)Quality of recovery score in post operative laproscopic cholecystectomy over 24 hours
2)To compare post-operative analgesia in the group with lignocaine and a group with combination of lignocaine and magnesium sulphate by NRS score at 0, 2, 4, 12 and 24 hour. |
|
Secondary Outcome
|
Outcome |
TimePoints |
To compare hemodynamics between the two groups intra-operatively and post operatively. |
Intar-operative and post- operative for 24 hours |
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
31/01/2022 |
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="6" Days="0" |
Recruitment Status of Trial (Global)
|
Other (Terminated) |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
Nil |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Post operative pain management is one of the most crucial step in a health care system. Opioid such as remifentanil are being used extensively. However its use are associated with many side effect like respiratory depression, chest wall rigidity, nausea, vomiting, drowsiness, pruritis, urinary retention, immunomodulation and post operativehyperalgesia(a paroxidal side effect of opioid). Alternative drugs are being studied and lignocaine and magnesium sulphate has been chosen for its lesser side effect and more beneficial. Systemic lignocaine is associated with less post operative pain due to its antinociceptive, antihyperanalgesia and antiinflamatory properties making lesser use of analgesia and general anaesthetic. On the other hand magnesium sulphate is NMDA receptor blocker that can prevent central sensitization after peripheral lesion or inflammation in the tissue because of inhibition of NMDA Receptor in the dorsal horn of spinal cord. In this study we compare the effectiveness of intravenous Lignocaine with intravenous Lignocaine and Magnesium sulphate combination for laparoscopic Cholecystectomy. |