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CTRI Number  CTRI/2018/05/013660 [Registered on: 03/05/2018] Trial Registered Prospectively
Last Modified On: 01/05/2018
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing two techniques of ultrasound guided nerve block for postoperative pain relief in patients for breast surgery. 
Scientific Title of Study   Ultrasound guided paravertebral block plus pectoral I block versus paravertebral block alone for postoperative analgesia in patients undergoing modified radical mastectomy: a prospective randomised study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anirban Roy 
Designation  Associate consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  anaesthesia office, room no 10,SSRB 5th floor, Sir Ganga Ram Hospital
1/27, 2nd floor old rajinder nagar. New Delhi
New Delhi
DELHI
110060
India 
Phone  9910181136  
Fax    
Email  dr.anirvan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anirban Roy 
Designation  Associate consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  anaesthesia office, room no 10,SSRB 5th floor, Sir Ganga Ram Hospital
1/27 , 2nd floor old rajinder nagar, New Delhi
New Delhi
DELHI
110060
India 
Phone  9910181136  
Fax    
Email  dr.anirvan@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Anirban Roy 
Designation  Associate consultant 
Affiliation  Sir Ganga Ram Hospital 
Address  anaesthesia office, room no 10,SSRB 5th floor, Sir Ganga Ram Hospital
1/27 2nd floor old rajinder nagar, New Delhi
New Delhi
DELHI
110060
India 
Phone  9910181136  
Fax    
Email  dr.anirvan@gmail.com  
 
Source of Monetary or Material Support  
Sir Ganga Ram Hospital, New Delhi 
 
Primary Sponsor  
Name  Sir Ganga Ram Hospital 
Address  Room no 10, SSRB 5th floor,sir ganga ram hospital, old rajinder nagar 
Type of Sponsor  Research institution and hospital 
 
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 Anirban Roy  Sir Ganga Ram Hospital  Anesthesia office. Room no 10, SSRB 5th floor, old rajinder nagar, New Delhi
New Delhi
DELHI 		 9910181136

dr.anirvan@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ethics Committee Sir Ganga Ram Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients having carcinoma breast undergoing modified radical mastectomy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group A: receiving general anaesthesia   Patients will receive standard general anaesthesia 
Intervention  Group B: receiving Ultrasound guided Paravertebral block and general anesthesia   Patients in GROUP B will receive ultrasound guided thoracic paravertebral block at level opposite the third, fourth, and fifth thoracic spine, ipsilateral to the side of surgery, under strict aseptic precautions with the patient in the lateral position. The probe will be placed in a parasagittal plane over the transverse process of T3, T4 and T5 vertebrae, approximately 2.5 cm lateral to the spinous processes. A 22-gauge, 50 mm, echogenic needle will be inserted in the thoracic paravertebral space. The block will be deemed satisfactory when the pleural membrane was displaced downwards during injection of 5 ml of 0.375% ropivacaine in each space. 
Intervention  Group C: receiving Ultrasound guided Paravertebral block and Pecs I block with general anesthesia  Patients in GROUP C will receive Paravertebral block as above along with pectoral I block under aseptic precautions. The probe will be placed below the lateral third of the clavicle, similar to what is done when performing infraclavicular brachial plexus block. After recognition of the appropriate anatomical structures, the block will be performed by using a 20gauge Tuohy needle. The needle will be advanced to the tissue plane between the pectoralis major muscle (PMm) and pectoralis minor muscle (Pmm) in the vicinity of the pectoral branch of the acromiothoracic artery, and 0.2 mL/kg of 0.375% ropivacaine will be deposited in the targeted area.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  1. Gender: female patients undergoing elective unilateral MRM surgery.
2. ASA physical status I, II and III
3. Age more than 18 years
 
 
ExclusionCriteria 
Details  1. Patient’s refusal
2. Declining to give written informed consent,
3. History of allergy to the medications used in the study,
4. Contraindications to regional anesthesia (including coagulopathy and local infection),
•Prior breast surgery except for diagnostic biopsies,
• History of treatment for a chronic pain condition and/or psychiatric disorder.
•ASA grade physical status III/IV
•Metabolic disorders (liver and kidney disease)
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Difference in duration of analgesia between three groups  Difference in duration of analgesia between three groups 
 
Secondary Outcome  
Outcome  TimePoints 
Intraoperative analgesic consumption  Throughout intraoperative period 
Acute postoperative pain relief as assessed by visual analogue scale (VAS)  At o, 30, 60, 90,120 minutes postoperatively 
Postoperative nausea and vomiting (PONV)  At 0, 30, 60, 90, 120 minutes postoperatively 
Patient satisfaction  At 0, 30, 60,90, 120 minutes postoperatively 
Assess difference in postoperative pain scores at 3 and 6 months   At 3 and 6 months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   10/05/2018 
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="2"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Breast cancer is most commonly diagnosed malignancy. Acute postoperative pain is a risk factor in development of chronic post mastectomy pain and seen in 40%patients after surgery. It has profound effect on health related quality of life, anxiety, depression, postoperative nausea and vomiting.They also show lower rates of satisfaction, increased hospital costs.
Regional anaesthesia techniques provide better control of acute pain leading to less postoperative chronic pain. Mechanism is decreased central sensitisation and improve patient outcome in terms of acute and persistent post surgical pain (PPSP). 
The advancement of ultrasound technology has increased interest in performing thoracic paravertebral and pectoral block
Our study prospectively compares ultrasound guided thoracic paravertebral block versus ultrasound guided paravertebral and pectoral I block in patients undergoing modified radical mastectomy surgery for duration of analgesia, postoperative pain,perioperative analgesic consumption, postoperative nausea and vomiting and PPSP.
 
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