| CTRI Number |
CTRI/2009/091/000108 [Registered on: 06/04/2009] |
| Last Modified On: |
28/02/2013 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
Modification(s)
|
To determine the efficacy and safety of Inj Diclofenac 75mg/ml given intradeltoid with Injection Diclofenac 75mg/3ml given intragluteal in the management of postoperative pain in obese patients. |
Scientific Title of Study
Modification(s)
|
A randomized comparative study evaluating efficacy and tolerability of injection Diclofenac sodium 75mg/1ml given intradeltoid versus injection Diclofenac sodium 75mg/3ml given intragluteal in the management of post operative pain in obese patients. |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
DrVijayaJaiswal |
| Designation |
|
| Affiliation |
|
| Address |
TroikaaPharmaceuticalsLimited
CommerceHouse1SatyaMarg Bodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
|
| Fax |
|
| Email |
vijayajaiswal@troikaapharma.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Vijaya Jaiswal |
| Designation |
|
| Affiliation |
|
| Address |
Troikaa Pharmaceuticals Limited
Commerce House 1 Satya Marg Bodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
|
| Fax |
07926856246 |
| Email |
vijayajaiswal@troikaapharma.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Vijaya Jaiswal |
| Designation |
|
| Affiliation |
|
| Address |
Troikaa Pharmaceuticals Limited
Commerce House 1 Satya MargBodakdev
Ahmadabad
GUJARAT
380054
India |
| Phone |
|
| Fax |
07926856246 |
| Email |
vijayajaiswal@troikaapharma.com |
|
Source of Monetary or Material Support
Modification(s)
|
| Troikaa Pharmaceuticals Limited |
|
Primary Sponsor
Modification(s)
|
| Name |
Troikaa Pharmaceuticals Limited |
| Address |
Commerce House 1, Opp.Rajvansh Apartment,
Satya Marg Bodakdev Ahmedabad 380054
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
Details of Secondary Sponsor
Modification(s)
|
|
Countries of Recruitment
Modification(s)
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr. JaishrI Bogra, |
Chhatrapati Shahuji Maharaj Medical University, U. P. |
Professor &Head, Department of Anestehsiology, ,Chhatrapati Shahuji Maharaj Medical University, -226 003
Lucknow
UTTAR PRADESH |
09839075895
jaishri.bogra@gmail.com |
| Dr. Madan Hardikar |
Hardikar Hospital |
1160/61 University Road,Shivajinagar-411005
Pune
MAHARASHTRA |
+912025535326
hardikar@vsnl.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Ethics Committee, Hardikar Hospital |
Approved |
| Office of the Research Cell, Chhatrapati Shahuji Maharaj Medical University, U. P. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Post Operative Pain , |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Injection Diclofenac sodium 75 mg/ 1 ml |
75 mg given intra-deltoid repeated every 12 hours for 2 days. |
| Comparator Agent |
Injection Diclofenac sodium 75 mg/ 3 ml |
75 mg given intra-gluteal repeated every 12 hours for 2 days. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group of 18 to 65 years
Patients of both sexes
Patients with BMI greater or equal to 25
Patients undergoing operative procedures requiring hospitalization for at least 48 hours
Patients with moderate to severe pain at baseline VAS 4 to10 |
|
| ExclusionCriteria |
| Details |
1.Patients below 18 years and above 65 years of age
2.Patients with BMI < or = 25
3.OPD patients/ patients requiring hospitalization less than 48 hours
4.Patients with compromised renal function
5.Pregnant and lactating women
6.Patients with history of bronchial asthma, peptic ulceration, bronchitis
7.Patients with coagulation disorders, especially bleeding disorders
8.Mentally retarded patients
9.Unwilling patients
10.Patients with known hypersensitivity to propylene glycol, diclofenac sodium any other NSAIDs or any component of either of the study formulations
11.Patients with a baseline VAS score of 3 or less than 3 |
|
Method of Generating Random Sequence
Modification(s)
|
Computer generated randomization |
Method of Concealment
Modification(s)
|
An Open list of random numbers |
Blinding/Masking
Modification(s)
|
Open Label |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Degree of pain relief, as assessed by a 5- point scale by patients |
At the end of 1, 4, 8 and 12 hours as compared to basal after each dose. |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Global efficacy by patients and investigator. |
End of Study (After 48 hrs) |
| Pain at the site of injection as assessed by visual analogue scale (VAS) |
At 1 hour and 12 hours after each dose. |
| Physicians evaluation of swelling, redness and induration at the site of injection |
After each dose
|
| Systemic Adverse Reactions and Rescue Medication |
Upto 48 hours. |
|
Target Sample Size
Modification(s)
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
Modification(s)
|
Phase 4 |
Date of First Enrollment (India)
Modification(s)
|
07/12/2008 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Submiited to Indian Journal of Anesthesia |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Non steroidal anti inflammatory drugs are alternatives to opioids as sole analgesic after minor surgery or as adjuvant to opioid analgesics following major surgery. One of the most commonly used NSAID for postoperative pain is diclofenac. Currently injection diclofenac is available as a 3 ml formulation and needs to be given deep intra-muscular usually intra-gluteal. A new formulation of injection diclofenac with reduced injection volume (1ml) has recently become available for clinical practice. Due to a lower injection volume it can also be given intra-deltoid. The aim of the study is to compare the efficacy and safety of the newer 1 ml formulation of injection diclofenac with the existing formulation in the management of post operative pain in obese patients. |