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CTRI Number  CTRI/2018/03/012463 [Registered on: 12/03/2018] 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 per anal tramadol and iv diclofenac against per anal tramadol and iv paracetamol for post operative pain relief in patients for lower abdominal surgeries. 
Scientific Title of Study   Comparison of rectal tramadol and intravenous diclofenac versus rectal tramadol and intravenous paracetamol for postoperative analgesia in patients undergoing 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  M.B.B.S M.D 
Affiliation  sdmcmsh dharwad 
Address  Associate professor .Dept of Anaesthesiology, SDM Medical College,Dharwad



580009
Other 
Phone  7829164500  
Fax    
Email  drmontygoudar@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Mahantesh Shivangouda Mudakanagoudar 
Designation  M.B.B.S M.D 
Affiliation  sdmcmsh dharwad 
Address  Associate professor .Dept of Anaesthesiology, SDM Medical College,Dharwad



580009
Other 
Phone  7829164500  
Fax    
Email  drmontygoudar@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Mahantesh Shivangouda Mudakanagoudar 
Designation  M.B.B.S M.D 
Affiliation  Associate professor 
Address  Associate professor .Dept of Anaesthesiology, SDM Medical College,Dharwad



580009
Other 
Phone  7829164500  
Fax    
Email  drmontygoudar@yahoo.co.in  
 
Source of Monetary or Material Support  
Shri Dharmasthal Manjunatheshwar college of medical sciences and hospital, sattur , Dharwad 
 
Primary Sponsor  
Name  SDM Medical College and Hospital 
Address  SDM Medical College and Hospital,SATTUR,DHARWAD..Pin- 580009 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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  Mahantesh   Associate professor .Dept of Anaesthesiology, SDM Medical College,Dharwad
Dharwad
KARNATAKA 		 7829164500
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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients posted for lower abdominal surgeries,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  1 Age-20-40yrs
- 2 ASA 1 and 2
- 3 Lower abdominal elective surgeries (as far as possible surgeries which has duration in ≤ 2 hours)

 
 
ExclusionCriteria 
Details  1 Patient refusal
2 Age <20 and >40 years
3 ASA 3 and 4
4 Patients with renal and liver impairment
5 Patients with bleeding diathesis
- Sensitive to opioids and NSAID
 
 
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 effect of tramadol suppository with a combination of tramadol and diclofenac suppository in lower abdominal surgeries.

 		 90 min 
 
Secondary Outcome  
Outcome  TimePoints 
To compare nausea and vomiting   90 min 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 1 
Date of First Enrollment (India)   12/12/2017 
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="10"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

 Studies have shown that tramadol is not an effective analgesic when used alone. To improve the quality of analgesia tramadol is usually combined with paracetamol or other NSAIDs. But there are no studies comparing tramadol suppository with a combination of tramadol and diclofenac in suppository form. So we decided to conduct this study.

 
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