| CTRI Number |
CTRI/2019/02/017850 [Registered on: 27/02/2019] Trial Registered Prospectively |
| Last Modified On: |
26/02/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
postoperative pain |
|
Scientific Title of Study
|
A multi-centric, comparative, randomized, double blind, parallel group, phase III clinical trial study to evaluate efficacy, safety & tolerability of the continuous intravenous infusion of Tramadol Infusion 0.1 % w/v versus Tramadol 50 mg/ ml injection for the treatment of patients with postoperative pain |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NEX/AKU/TRA/CT-III/2014 Version 3.1, Date 29 Aug 2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrikant Deshpande |
| Designation |
Investigator |
| Affiliation |
Ashirwad Hospital and Research Centre, |
| Address |
Ashirwad Hospital and Research Centre, Maratha Section, Ulhasnagar
Thane
MAHARASHTRA
421004
India |
| Phone |
9987553071 |
| Fax |
|
| Email |
pm_medaffairs@nexuscro.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangesh Khadakban |
| Designation |
Clinical Operations |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9167243914 |
| Fax |
|
| Email |
mangesh.khadakban@nexuscro.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangesh Khadakban |
| Designation |
Clinical Operations |
| Affiliation |
Nexus Clinical Research (India) Ltd. |
| Address |
Nexus Clinical Research (India) Ltd
32A Nexus Centre For Clinical Excellence,
Shiravane Road Service Industry Sector 1
Mumbai Pune Highway Nerul,
Navi Mumbai India
Mumbai (Suburban)
MAHARASHTRA
400706
India |
| Phone |
9167243914 |
| Fax |
|
| Email |
mangesh.khadakban@nexuscro.com |
|
|
Source of Monetary or Material Support
|
| Akums Drugs & Pharmaceutical Ltd India |
|
|
Primary Sponsor
|
| Name |
Akums Drugs Pharmaceutical Ltd India |
| Address |
304, Mohan Place,Local Shopping Complex,Block - C, Saraswati Vihar,New Delhi - 110034 |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NEXUS CLINICAL RESEARCH INDIA LTD |
Nexus Solitaire, Plot no. 4A, Sector 9, Nerul (East),
Navi Mumbai- 400706
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrikant Deshpande |
Ashirwad Hospital and Research Centre |
Department of Medicine, Second Floor, Maratha Section Ulhasnagar
Thane
MAHARASHTRA |
9987553071
pm_medaffairs@nexuscro.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ashirwad Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Tramadol Infusion 0.1 % w/v |
Akums Drugs & Pharmaceutical Ltd India
Infusion, intravenously.
After recovery from anesthesia, Initial intravenous loading dose of 100 mg tramadol bolus, followed by an infusion of 0.1%w/v at 12.5 mg/hour for 12 hours should be given. |
| Comparator Agent |
Trump Injection (Tramadol hydrochloride 50 mg/ ml) |
Injection, intravenously
After recovery from anesthesia, Initial intravenous loading dose of 100 mg bolus Tramadol injection, followed by 50-100 mg tramadol injection with given time of interval (2-3hours) only when there is pain to the patient. (at the discretion of investigator). |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients of ASA(American Society of Anesthesiologists) physical status I and II determined to undergo elective surgery of any etiology under general anesthesia (Hip/Knee Arthroplasty, Open Cholecystectomy).
2 Hospital stay at least for 24 hours is needed.
3 Cooperative and understanding skills.
4 Agreement to informed consent form. |
|
| ExclusionCriteria |
| Details |
1 Hypersensitivity to any of the drugs components or other drug from same class.
2 Patient unable to refrain from alcohol, psychoactive drugs, and sedatives including sleeping preparations (e.g. benzodiazepines) for the duration of their participation in the study
3 Patient with history of drug of abuse.
4 Patients at risk for respiratory depression, patients with increased intracranial pressure or head injury, suffering from severe headache.
5 Pregnant and lactating woman |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine change in Visual Analog scale pain score |
at day 1 (48 hours), day 2 (72 hours) and at end of study from baseline, |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine change in Visual Analog scale pain score |
till 24 hours (average cumulative scores during 24 hours post dose) as compared to baseline score. |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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 |
|
Date of First Enrollment (India)
|
05/03/2019 |
| 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="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This will be a phase III, multi-centric, comparative, randomized, double blind, parallel group, clinical study. The study will begin with screening evaluation. Clinical test reports (If available) of patients will be assessed at screening. Patients of ASA(American Society of Anesthesiologists) physical status I and II determined to undergo elective surgery of any etiology under general anesthesia (Hip/Knee Arthroplasty, Open Cholecystectomy) satisfying all the inclusion criteria at randomization visit will be randomized to either of the study arms after surgery. |