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CTRI Number  CTRI/2025/01/079183 [Registered on: 21/01/2025] Trial Registered Prospectively
Last Modified On: 20/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Two Different Doses Of Epidural Tramadol For Postoperative Analgesia In Patients Undergoing Upper Abdominal Surgery 
Scientific Title of Study   A Comparative Study to Evaluate Two Different Doses of Epidural Tramadol for Postoperative Analgesia in Patients Undergoing Upper Abdominal Surgery 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Diya Rajan 
Designation  Resident Doctor 
Affiliation  B J Medical College, Ahmedabad  
Address  Dept of Anaesthesia, B.J. Medical College and hospital, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9495037715  
Fax    
Email  diyarajan001@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Nilesh Solanki 
Designation  Associate Professor 
Affiliation  B. J. Medical college Ahmedabad 
Address  Dept of Anaesthesia, B.J. Medical College and hospital, Asarwa, Ahmedabad

Ahmadabad
GUJARAT
380016
India 
Phone  9998991716  
Fax    
Email  nmscbaps@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nilesh Solanki 
Designation  Associate Professor 
Affiliation  B. J. Medical college Ahmedabad 
Address  Dept of Anaesthesia, B.J. Medical College and hospital, Asarwa, Ahmedabad


GUJARAT
380016
India 
Phone  9998991716  
Fax    
Email  nmscbaps@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, BJMC, Ahmedabad, Gujarat, India 380016 
 
Primary Sponsor  
Name  Government supply 
Address  B J Medical College, Civil Hospital, Ahmedabad, Gujarat, India, 380016 
Type of Sponsor  Government 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 
Dr Diya Rajan  Civil hospital Ahmedabad  Department of Anaesthesiology, BJMC Ahmedabad
Ahmadabad
GUJARAT 		 9495037715

diyarajan001@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
The Institutional Ethics Committee, B. J. Medical College & Civil Hospital, Ahmedabad   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K00-K95||Diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Inj. Tramadol 1mg/kg body weight   Inj. Tramadol 1mg/kg body weight, route of administration - Epidural catheter, dose repeated when NRS score more than or equal to 4, till 24hrs 
Comparator Agent  Inj. Tramadol 2mg/kg body weight  Inj. Tramadol 2mg/kg body weight, route of administration- Epidural catheter, dose repeated when NRS score more than or equal to 4, till 24hrs 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA grade I and II, Patients scheduled for upper abdominal surgeries, Elective surgeries 
 
ExclusionCriteria 
Details  ASA grade III, IV and V
Age less than 18 and more than 60 years
Patients refusing to give consent
Patients who are pregnant or lactating
Patients having any bleeding diathesis or are on anticoagulant therapy 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.To compare duration of analgesia in both groups
2.To study postoperative pain relief in both groups (by numerical rating scale for pain intensity) 		 24 hours postoperative  
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare postoperative complication in both groups.
2.Postoperative hemodynamic parameters in both groups.
 		 24 hours postoperative  
 
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 4 
Date of First Enrollment (India)   31/01/2025 
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="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  

The aim of postoperative analgesia is to provide subjective comfort with minimum side effects, with early ambulation and restoration of function. In upper abdominal surgery, the severity of postoperative pain is higher and it restricts the movement of diaphragm which increases the incidence of respiratory complications, hospital stay, surgical morbidity and mortality in these surgeries. Regional analgesia techniques like epidural analgesia with the introduction of local anaesthetics or opioids or mixture of the two in the epidural space is an established method of effective postoperative analgesia. Tramadol hydrochloride is an atypical centrally acting opioid with mixed opioid and non-opioid activity. Epidural tramadol has the benefit of lack of respiratory depresssant effect along with prolonged postoperative pain relief. The aim of the present study is to find out an optimum dose of tramadol hydrochloride to be used epidurally in upper abdominal surgery patients, based on body weight.

 

 
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