| CTRI Number |
CTRI/2021/10/037110 [Registered on: 05/10/2021] Trial Registered Prospectively |
| Last Modified On: |
15/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Post operative analgesia of Nefopam in laparoscopic surgery |
|
Scientific Title of Study
|
COMPARISION OF POST OPERATIVE ANALGESIC EFFECT OF NEFOPAM HYDROCHLORIDE AND DICLOFENAC SODIUM IN LAPROSCOPIC SURGERY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Darshan n |
| Designation |
junior Resident |
| Affiliation |
P D U Medical college , Rajkot |
| Address |
Department of Anaesthesiology
OPD Building 3rd floor
P D U MEDICAL COLLEGE RAJKOT
near hospital chowk
Rajkot
sri gavi ranganatha nilaya
gandhi nagara 3rd cross
chickmagalur
karnataka 577101
Rajkot
GUJARAT
360001
India |
| Phone |
07353543443 |
| Fax |
|
| Email |
darshann59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana S Parmar |
| Designation |
Professor and HOD |
| Affiliation |
P D U Medical college , Rajkot |
| Address |
Department of Anaesthesiology
OPD Building 3rd floor
P D U medical college
Near hospital chowk
Rajkot
Department of Anaesthesiology
OPD Building 3rd floor
P D U medical college
Near hospital chowk
Rajkot
Rajkot
GUJARAT
360001
India |
| Phone |
07353543443 |
| Fax |
|
| Email |
drvandanapithadia@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Darshan n |
| Designation |
junior Resident |
| Affiliation |
P D U Medical college , Rajkot |
| Address |
Department of Anaesthesiology
OPD Building 3rd floor
P D U medical college
Near hospital chowk
Rajkot
Department of Anaesthesiology
OPD Building 3rd floor
P D U medical college
Near hospital chowk
Rajkot
Rajkot
GUJARAT
360001
India |
| Phone |
07353543443 |
| Fax |
|
| Email |
darshann59@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
P D U medical college
Rajkot |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology P D U medical college Rajkot |
| Address |
P D U Medical college
near hospital chowk
Rajkot 360001 |
| 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 |
| Darshan N |
P D U MEDICAL COLLEGE RAJKOT |
Department of Anaesthesiology
Near hospital chowk
Rajkot
Rajkot
GUJARAT |
7353543443
darshann59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INDTITUTIONAL ETHICS COMMITEE,PDU MEDICAL COLLEGE RAJKOT |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K37||Unspecified appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Diclofenac Sodium |
1.5mg/kg IV given before 15-20 mins of Extubation |
| Intervention |
NEFOPAM HYDROCHLORIDE |
0.3-0.4mg/kg IV given before 15-20 mins of Extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All Abdominal Laparoscopic surgeries of ASA grade 1 ,2, 3 |
|
| ExclusionCriteria |
| Details |
patient refusal,
hepatic and renal insufficiency,
patients on tricyclic anti depressants and MOA inhibitor ,
pregnancy and lactation ,
convulsive disorder |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nefopam as compared to NSAIDS , due to its opioid sparing effect and no effect on platelet function it may prove to be useful non opioid adjuvant in laparoscopic abdominal surgeries |
6-10 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| decreased post operative nausea and vomiting and post operative shivering |
Baseline,1 hour , 2 hour |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/10/2021 |
| Date of Study Completion (India) |
15/11/2021 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="6" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This Study is a randomized , double blind ,parallel group single center trial comparing post operative analgesic effect of nefopam hydrochloride and diclofenac sodium in laparoscopic surgery . The primary outcome measures will be duration of post operative analgesia . The secondary outcome will be of effect of nefopam on post operative nausea and vomiting ,post operative shivering . |