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CTRI Number  CTRI/2018/04/012915 [Registered on: 02/04/2018] Trial Registered Prospectively
Last Modified On: 11/06/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two pain reducing techniques after breast cancer surgery. 
Scientific Title of Study   Comparison of efficacy of Ultrasound guided Paravertebral Block versus Erector Spinae Plane block for Postoperative Analgesia in Modified Radical Mastectomy : A Randomized Controlled Trial  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shilpi Agarwal 
Designation  Senior Resident 
Affiliation  AIIMS , NEW DELHI 
Address  Department of Onco Anaesthesia and Palliative Medicine, DR BRAIRCH, AIIMS; New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  drshilpi87@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sachidanand Jee Bharati 
Designation  Associate Professor 
Affiliation  AIIMS , NEW DELHI 
Address  RN 139 , 1st Floor, Department of Onco Anaesthesia and Palliative Medicine, DR BRAIRCH, AIIMS; New Delhi

South
DELHI
110029
India 
Phone  9968436042  
Fax    
Email  sachidadr@yahoo.co.in  
 
Details of Contact Person
Public Query
 
Name  Dr Shilpi Agarwal 
Designation  Senior Resident 
Affiliation  AIIMS , NEW DELHI 
Address  Department of Onco Anaesthesia and Palliative Medicine, DR BRAIRCH, AIIMS; New Delhi


DELHI
110029
India 
Phone    
Fax    
Email  drshilpi87@gmail.com  
 
Source of Monetary or Material Support  
NA 
 
Primary Sponsor  
Name  AIIMS  
Address  AIIMS , New Delhi - 110029 
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 Shilpi Agarwal  AIIMS , New Delhi  RN 139 ,1st Floor , Deparment of Onco-Anaesthesia and Palliative Medicine, DRBRAIRCH,AIIMS ,New Delhi
South
DELHI 
9650797105

drshilpi87@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Aiims  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients with breast cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group E  Ultrasound guided Erector spinae plane block will be given at T5 level along with general anaesthesia in MRM 
Comparator Agent  Group P  Ultrasound guided Paravertebral block will be given at T4 level along with general anaesthesia in MRM 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1. ASA I and II
2. Patients posted for MRM
3. Patients giving written informed consent to participate in the study
 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Age <18 or > 70 years
3. Patients with BMI > 35kg/m2
4. Patient with infection at the site of injection
5. Coagulopathy
6. Spine deformity
7. Drug addicts or history of opioid dependence
8. Patients with history of allergy to opioids or local anaesthetics
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To measure the duration of post-operative analgesia (that is, time to first analgesic request from the time of giving block ).
 
Pain assessment would be done in immediate post (0 min), 30 min, 1 hr , 2hr , 6hr, 12 and 24 hr. 
 
Secondary Outcome  
Outcome  TimePoints 
1) Total rescue analgesic requirement in postoperative period.
2) To evaluate patient satisfaction in postoperative period.
 
Patient satisfaction would be evaluated at 24 hrs after surgery 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/04/2018 
Date of Study Completion (India) 16/05/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Acute postoperative pain due to insufficient pain control is a major risk factor for development of chronic pain after breast surgery. Regional anaesthesia is considered protective for cancer recurrence by its direct and indirect anti proliferative effects. Use of these techniques is associated with better pain control , decreased opioid consumption and their side effects. Paravertebral block is a established regional anaesthesia and analgesia technique for breast cancer surgeries.However erector spinae plane block is a novel interfacial block technique which can be a viable alternative to paravertebral block due to its fast , easy and safe execution . There are numerous studies on paravertebral block but there is a very limited literature on erector spinae plane block in breast surgeries and there is no study comparing paravertebral block with erector spinae plane block in breast surgeries.Thus we are performing this randomized controlled trial to compare the efficacy of paravertebral block with erector spinae plane block in breast surgeries in total 80 patients ( 40 in each group). In Group P , ultrasound guided paravertebral block will be given at T4 level with 20 ml of 0.5 % Ropivacaine and in Group E , ultrasound guided erector spinae plane block will be given at T5 level with 20 ml of 0.5 % Ropivacaine. After giving the block , GA will be given.Any block related complications will be noted. In postoperative period the efficacy of both the blocks will be compared in terms of duration of postoperative analgesia (time to first rescue analgesic ) , total number of rescue analgesics required and patient satisfaction .

 
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