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CTRI Number  CTRI/2020/11/028900 [Registered on: 04/11/2020] Trial Registered Prospectively
Last Modified On: 29/10/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized Factorial Trial 
Public Title of Study   A clinical trial to evaluate the efficacy of wound instillation with ropivacine with fentanyl or dexmedetomidine or morphine for post operative analgesia in patients undergoing mastectomy. 
Scientific Title of Study   To evaluate the efficacy of instillation of ropivacaine with fentanyl or dexmedetomidine or morphine through surgical drains for post operative analgesia in patients undergoing mastectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Naveen Malhotra 
Designation  professor 
Affiliation  Pt BD SHARMA PGIMS ROHTAK 
Address  Department of Anesthesiology and Critical care PGIMS ROHTAK

Rohtak
HARYANA
124001
India 
Phone    
Fax    
Email  drnaveenmalhotra@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Sanjay Johar 
Designation  professor 
Affiliation  Pt BD SHARMA PGIMS ROHTAK 
Address  Department of Anesthesiology and Critical care PGIMS ROHTAK

Rohtak
HARYANA
124001
India 
Phone  9416050652  
Fax    
Email  sanjays321@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Naveen Malhotra 
Designation  professor 
Affiliation  Pt BD SHARMA PGIMS ROHTAK 
Address  Department of Anesthesiology and Critical care PGIMS ROHTAK


HARYANA
124001
India 
Phone    
Fax    
Email  drnaveenmalhotra@yahoo.co.in  
 
Source of Monetary or Material Support  
PT BD SHARMA PGIMS ROHTAK 
 
Primary Sponsor  
Name  PT BD SHARMA PGIMS ROHTAK 
Address  PT BD SHARMA PGIMS ROHTAK HARYANA 124001 
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 Sumit PG Student Department of Anaesthesiology  Pt BD Sharma PGIMS  Department of Anesthesiology and Critical care
Rohtak
HARYANA 		 8447094050

sumitdas211@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee PGIMS/UHS ROHTAK  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  wound instillation with local anaesthetics through surgical drain   wound instillation with 40 ml 0.25 % ropivacaine with 4.5 mg morphine ( frequency: Single Dose ) through surgically placed drains to manage Post mastectomy pain. The drugs will be administered locally through surgical drains at the end of surgery. The surgical drains will be clamped for a period of twenty minutes after instillation of the study drug. After a dwell time of twenty minutes the clamp will be released to allow the drug solution (if any) in to the negative pressure suction drain.  
Comparator Agent  wound instillation with local anaesthetics through surgical drain   wound instillation with ropivacaine with 50 microgram fentanyl or 1 microgram/kg dexmedetomidine through surgically placed drains to manage Post mastectomy pain. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Adult female patients
Age between 30-70 years
ASA Physical Status Class I & II scheduled for mastectomy with axillary clearance.
 
 
ExclusionCriteria 
Details  Patients with uncontrolled cardiovascular, pulmonary, hepatic, renal, neurologic, psychiatric diseases or diabetes mellitus; major blood loss during surgery or continued excessive blood collection in to the drains and having allergy to the study drugs. 
 
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 
1 Pain Score
2 Duration of analgesia
3 Need for rescue analgesia
4 Side effects if any 		 Intra operative and 24 hour post operative period 
 
Secondary Outcome  
Outcome  TimePoints 
Heart rate Blood pressure Spo2
Visual Analogue Score at Rest
Visual Analogue Score on movement 		 Intra operative and 24 hour post operative period 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
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   N/A 
Date of First Enrollment (India)   05/11/2020 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

There are many studies on  wound instillation with ropivacaine and bupivacaine, that has produced promising results in postoperative pain management. But few studies have been done to evaluate the efficacy of instillation of ropivacaine with fentanyl or dexmedetomidine or morphine in surgical field for postoperative analgesia. Therefore we propose to conduct this study to evaluate the efficacy of instillation of ropivacaine with fentanyl or dexmedetomidine or morphine through surgical drains for post operative analgesia in patients undergoing mastectomy.

 
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