| CTRI Number |
CTRI/2023/09/058015 [Registered on: 26/09/2023] Trial Registered Prospectively |
| Last Modified On: |
23/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Compare Tramadol with lignocaine and ropivacaine to assess pain relief in children undergoing hernia surgeries |
|
Scientific Title of Study
|
“EFFECT OF TRAMADOL WITH 2%LIGNOCAINE AND ADRENALINE VERSUS 0.2% ROPIVACAINE IN WOUND INFILTRATION IN PAEDIATRIC HERNIOTOMY PATIENTS FOR POSTOPERATIVE PAIN RELIEF : A RANDOMIZED CONTROLLED DOUBLE BLINDED STUDYâ€
|
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ramya krishna |
| Designation |
PG RESIDENT |
| Affiliation |
IMS AND SUM HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY,
IMS AND SUM HOSPITAL,
BHUBANESWAR,751003
Khordha
ORISSA
750017
India |
| Phone |
9666397123 |
| Fax |
|
| Email |
ramya.manjula134@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
RANJITA ACHARYA |
| Designation |
PROFESSOR |
| Affiliation |
IMS SUM HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
IMS AND SUM HOSPITAL
BHUBANESWAR
Khordha
ORISSA
751003
India |
| Phone |
9666397123 |
| Fax |
|
| Email |
drranjitaacharya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ramya Krishna |
| Designation |
PG resident |
| Affiliation |
IMS SUM HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY
IMS AND SUM HOSPITAL
BHUBANESWAR
Khordha
ORISSA
750017
India |
| Phone |
9666397123 |
| Fax |
|
| Email |
ramya.manjula134@gmail.com |
|
|
Source of Monetary or Material Support
|
| INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL
BHUBANESWAR
751003
ODISHA |
|
|
Primary Sponsor
|
| Name |
INSTUTITE OF MEDICAL SCIENCES AND SUM HOSPITAL |
| Address |
DEPARTMENT OF ANESTHESIOLOGY, BHUBANESWAR. |
| Type of Sponsor |
Private 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 |
| Dr Ramya manjula |
IMS SUM HOSPITAL |
department of anesthesiology
Khordha
ORISSA |
9666397123
ramya.manjula134@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE OF MEDICAL SCIENCES AND SUM HOSPITAL |
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 |
Inj. 0.2% Ropivacaine |
Inj. 0.2% Ropivacaine 0.3ml/kg for wound infiltration to assess postoperative pain relief duration |
| Intervention |
Inj. Tramadol with 2%Lignocaine and Adrenaline
|
Tramadol 2mg/kg with 2%Lignocaine and Adrenaline in total 0.3ml/kg
for wound infiltration we assess the postoperative pain relief duration after wound infiltration in pediatric herniotomy cases |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing paediatric herniotomy cases
3-8 yrs age group
ASA 1&2 |
|
| ExclusionCriteria |
| Details |
Patients under ASA III, ASA IV
Patients with coagulation disorders
Patient known allergic to local anesthetic agents and opioids
Skin infection at local sites
Parents or guardians refusal to give consent |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wong baker faces pain scale is used to compare postoperative Pain relief |
0,1,2,4,12,24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Need for rescue analgesic
Hemodynamic parameters(MAP, SpO2,HR)
Side effects(nausea vomiting itching) |
0,1,2,4,12,24 hrs |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
04/10/2023 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
A randomised controlled prospective double blinded study is being done to compare the effect of pain relief in paediatric herniotomy cases using wound infiltration with study drugs as tramadol with 2% lignocaine and adrenaline vs 0.2 % ropivacaine. |