| CTRI Number |
CTRI/2022/03/041115 [Registered on: 15/03/2022] Trial Registered Prospectively |
| Last Modified On: |
14/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
The study is a comparative study between intravenous Lignocaine with intravenous Lignocaine and magnesium sulphate combination for laparoscopic Nephrectomy to evaluate the effectiveness of pain management during post operative in 24 hours |
|
Scientific Title of Study
|
Comparison of intravenous Lignocaine with intravenous Lignocaine and Magnesium sulphate combination for laparoscopic Nephrectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
manom konyak |
| Designation |
Junior resident 1st year |
| Affiliation |
Indira Gandhi Institute of Medical Science,Patna,Bihar. |
| Address |
Department of Anaesthesia and critical care Medicine,
IGIMS,Patna,
Bihar.
wagiem ward ,mon,nagaland
Patna
BIHAR
800001
India |
| Phone |
8731955881 |
| Fax |
|
| Email |
nokzei22@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
manom konyak |
| Designation |
Junior resident 1st year |
| Affiliation |
Indira Gandhi Institute of Medical Science,Patna,Bihar. |
| Address |
Department of Anaesthesia and Critical Care Medicine,
IGIMS,Patna,
Bihar.
wagiem ward ,mon,nagaland
Patna
BIHAR
800001
India |
| Phone |
8731955881 |
| Fax |
|
| Email |
nokzei22@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Swati |
| Designation |
Additional Professor. |
| Affiliation |
Indira Gandhi Institute of Medical Science,Patna,Bihar |
| Address |
Department of Anaesthesiology and Critical Care Medicine,IGIMS,Patna,Bihar.
Patna
BIHAR
800001
India |
| Phone |
9113463130 |
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indira Gandhi Institute of Medical Science,Patna,Bihar. |
|
|
Primary Sponsor
|
| Name |
Indhira gandhi institue of medical sciencePatna |
| Address |
Department of Anaesthesiology and Critical Care Medicine,Ward BLOCK,First floor,Patna,Bihar. |
| 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 |
| Manom Konyak |
Indira Gandhi Institute of Medical Sciences |
Department of Anaesthesiology and Critical Care Medicine,IGIMS,Sheikhpura , Patna,Bihar
Patna
BIHAR |
8731955881
nokzei22@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,IGIMS,Patna,Bihar. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
To assess the effectiveness of post operative pain in laparoscopic nephrectomy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Elective laparoscopic Nephrectomy |
|
| ExclusionCriteria |
| Details |
1 Refused consent,
2 Allergic to local anaesthetic agent and opiods
3 on long term analgesic to chronic pain
4 Impaired liver function
5 Has a history of arrhythmia
6 Viral marker reactive
7 Covid 19 positive. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| quality of recovery score |
at 24 hr postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
hemodynamics every 30 min after starting infusion.
NRS pain score
total opioid consumption |
24 hrs postoperative period |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 4 |
|
Date of First Enrollment (India)
|
01/04/2022 |
| 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="1"
Months="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
study not yet started. After completion of study I will send for publication |
|
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 - None of the above
- 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 (Others) - can be mailed
- For how long will this data be available start date provided 15-04-2021 and end date provided 09-06-2023?
Response (Others) -
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
The study is taken to compare the management of pain in post laparoscopic Nephrectomy with the combination of intravenous Lignocaine and the combination of intravenous Lignocaine and magnesium sulphate for better pain control during the post operative period |