| CTRI Number |
CTRI/2018/03/012446 [Registered on: 09/03/2018] Trial Registered Retrospectively |
| Last Modified On: |
06/03/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the pain control effect of tramadol suppository with a combination of tramadol and diclofenac suppository after infraumbilical surgeries. |
|
Scientific Title of Study
|
Comparison of the analgesic effect of tramadol suppository with a combination of tramadol and diclofenac suppository after lower abdominal surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mahantesh Shivangouda Mudakanagoudar |
| Designation |
associate professor |
| Affiliation |
sdmcmsh dharwad |
| Address |
Associate professor .Dept of Anaesthesiology, SDM Medical College,Dharwad
Associate professor .Dept of Anaesthesiology, SDM Medical College,Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7829164500 |
| Fax |
0836247777 |
| Email |
drmontygoudar@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Mahantesh Shivangouda Mudakanagoudar |
| Designation |
associate professor |
| Affiliation |
sdmcmsh dharwad |
| Address |
Associate professor .Dept of Anaesthesiology, SDM Medical College,Dharwad
Associate professor .Dept of Anaesthesiology, SDM Medical College,Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7829164500 |
| Fax |
0836247777 |
| Email |
drmontygoudar@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Mahantesh Shivangouda Mudakanagoudar |
| Designation |
associate professor |
| Affiliation |
sdmcmsh dharwad |
| Address |
Associate professor .Dept of Anaesthesiology, SDM Medical College,Dharwad
Associate professor .Dept of Anaesthesiology, SDM Medical College,Dharwad
Dharwad
KARNATAKA
580009
India |
| Phone |
7829164500 |
| Fax |
0836247777 |
| Email |
drmontygoudar@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Shri Dharmasthal Manjunatheshwar College of Medical Sciences and Hospital , Dharwad |
|
|
Primary Sponsor
|
| Name |
Shri Dharmasthal Manjunatheshwar College Of Medical Sciences and Hospital |
| Address |
Shri Dharmasthal Manjunatheshwar College Of Medical Sciences and Hospital,Sattur Dharwad..580009 |
| 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 |
| Mahantesh Mudakanagoudar |
SDM medical college , Dharwad, Karnataka |
Associate professor .Dept of Anaesthesiology, SDM Medical College,Dharwad
Dharwad
KARNATAKA |
7829164500
drmontygoudar@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sdmcmshdharwad |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA 1 and 2 posted for lower abdominal surgeries, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.ASA class 1 and 2
2. Undergoing elective lower abdominal surgeries under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
1.ASA status more than 2;
2.major co-existing medical illness such as severe asthma, uncontrolled hypertension or diabetes; peptic ulcer disease or gastrointestinal bleeding; 3.already on long-term analgesics
4.known hypersensitivity to any of the study medications. |
|
|
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 |
| to compare the analgesic efficacy and side effect profile between the rectal tramadol 100mg with combination of rectal tramadol 50mg and rectal diclofenac 50mg in patients undergoing lower abdominal surgeries. |
90 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare nausea and vomiting |
90 min |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/03/2016 |
| Date of Study Completion (India) |
10/10/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="10"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To
reduce the side effects of both tramadol and diclofenac, combination of
tramadol and diclofenac with half of the standard dose of the both drugs were tried in this
study. Our Medline search
to best of our ability, did not find any study which has evaluated/compared
rectal tramadol (100 mg) with combination of rectal tramadol
50mg and rectal diclofenac 50mg. Thus, the aim of the study was
to compare the analgesic efficacy and side effect profile between the rectal
tramadol 100mg with combination of rectal tramadol 50mg and rectal diclofenac
50mg in patients undergoing lower abdominal surgeries. |