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CTRI Number  CTRI/2023/07/055300 [Registered on: 17/07/2023] Trial Registered Prospectively
Last Modified On: 17/07/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A comparison of quality of recovery after erector spinae block given with 20ml vs 30 ml of 0.375% Ropivacaine in patients undergoing modified radical mastectomy. 
Scientific Title of Study   A randomized double blind study comparing quality of recovery after erector spinae block given with 20ml vs 30ml of 0.375% Ropivacaine in patients undergoing modified radical mastectomy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nirakar Pahadi 
Designation  DNB trainee 
Affiliation  Tata Main Hospital , Jamshedpur 
Address  Dept of Anaesthesiology , Tata Main Hospital , Jamshedpur
Dept. of Anaesthesiology , Tata Main Hospital , Jamshedpur, 831001
Purbi Singhbhum
JHARKHAND
831001
India 
Phone  9040143917  
Fax    
Email  nirakarpahadi190@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Srividhya 
Designation  Senior Consultant 
Affiliation  Tata Main Hospital , Jamshedpur 
Address  Dept of Anaesthesiology , Tata Main Hospital , Jamshedpur
Dept. of Anaesthesiology , Tata Main Hospital , Jamshedpur, 831001
Purbi Singhbhum
JHARKHAND
831001
India 
Phone  7763807752  
Fax    
Email  drsrividhya@tatasteel.com  
 
Details of Contact Person
Public Query
 
Name  Dr Srividhya 
Designation  Senior Consultant 
Affiliation  Tata Main Hospital , Jamshedpur 
Address  Dept of Anaesthesiology , Tata Main Hospital , Jamshedpur
Dept. of Anaesthesiology , Tata Main Hospital , Jamshedpur, 831001
Purbi Singhbhum
JHARKHAND
831001
India 
Phone  7763807752  
Fax    
Email  drsrividhya@tatasteel.com  
 
Source of Monetary or Material Support  
TATA MAIN HOSPITAL , JAMSHEDPUR 
 
Primary Sponsor  
Name  Tata Main Hospital  
Address  Dept. of Anaesthesiology , Tata Main Hospital , Jamshedpur, 831001 
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 
Nirakar Pahadi  Tata Main Hospital  Dept. of Anaesthesiology , Tata Main Hospital , Jamshedpur, 831001
Purbi Singhbhum
JHARKHAND 
9040143917

nirakarpahadi190@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE , Tata Main Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Different volume of Ropivacaine 0.375%  In this arm general anaesthesia will be induced and after giving erector spinae plane block 30ml of 0.375% Ropivacaine will be administered. 
Intervention  ERECTOR SPINAE PLANE BLOCK   In this arm general anesthesia will be induced and after giving erector spinae plane block 20ml of 0.375% Ropivacaine will be administered. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Female 
Details  ASA grade 1 to 3.
Patients undergoing single side modified radical mastectomy for breast cancer. 
 
ExclusionCriteria 
Details  Patients refusing to participate in study.
Bilateral breast surgery.
Patients with allergy to local anesthetics.
Patients with coagulopathy , infection at site of block and patients with neurological deficits.
Patients on anti depressants or psychiatric drugs.
Patients previously on pain medication. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean QoR (Quality of Recovery) 40 Score  24 HOURS 
 
Secondary Outcome  
Outcome  TimePoints 
Mean 24 hours VAS score.
Mean opioid consumption in first 24 hours post operatively.
Duration of block (Time of administration of block to first dose of rescue analgesic). 
0, 30, 60, 90 minutes and then 2, 4, 6, 12, 16, 20 and 24 hours. 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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)   28/07/2023 
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="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  
     Modified radical mastectomy is one of the most frequently practiced surgery . In MRM there is substantial dissection of nerve fibres. so, post op analgesia is difficult to provide. The incidence of post mastectomy pain syndromes is 20-60%. Quality of recovery after the surgery becomes an important parameter for a good postoperative outcome. One of the components of quality of recovery is good post operative pain management . Regional anaesthesia in the form of  fascial blocks have taken the lead in this field. Erector Spinae Block - decreases acute post op pain, improve the quality of recovery in patients undergoing MRM surgeries.
     Research question: Is the quality of recovery (QoR 40 Score) better when erector spinae plane block is given with 20ml of 0.375% Ropivacaine as compared to 30 ml of 0.375% Ropivacaine in patients undergoing modified radical mastectomy?
     Objectives: Primary objective is to compare patient improvement with Quality of Recovery 40 (QoR 40) day after surgery. Secondary objective is  24 - hour postoperative pain scores (VAS) , post operative opioid consumption, time of first dose of rescue analgesic .
     Methodology: Randomized Prospective Double blind study from 1.04.23 – 31.10.24 at Tata Main Hospital, Jamshedpur. Randomization will be done by computer generated random number. Blinding:  the patient will be blind to the volume of drug used. Also, the person collecting the data and analyzing in the postoperative period will be different from the person doing the ESP Block. First GA will be administered with IV Fentanyl 2 mcg/kg, Propofol 2.5mg/kg, Vecuronium 0.1mg/kg at induction & ET intubation . After that patient is shifted to lateral position and a Single shot ESP block – US guided 13-6 Mhz (Sonosite  M turbo), at T4 level using 100mm 20G USG needle (Stimuplex Ultra 360) is done . A volume of 0.375% Ropivacaine according to the group assigned is administered. Blocks will be performed by an anaesthesiologist who has previously done 25 or more ESPB before the commencement of study. Group A - patients will receive ultrasound guided ESPB with 20 ml of 0.375% Ropivacaine of along with general anaesthesia . Group B – patients will receive ultrasound guided ESPB with 30 ml of 0.375% Ropivacaine  along with general anaesthesiaPatient is  made Supine and 60 minutes after induction – Morphine 0.1 mg/kg IV is given. Maintenance in the form of O2/N2O, Vecuronium, Isoflurane is administered. Paracetamol 1gm IV half hour before end of surgery and 8 hourly postop and rescue analgesia in the form of  Injection Tramadol 1.5 mg/kg  when VAS≥4 is administered. Observations in the form of QoR - 40 Score (using QoR-40 Recovery  Assessment Format), VAS score at 0,30,60,90(mins) 2 hours, 4,6,12,16,20,24 hours , time of first rescue analgesic, total requirement of opioid in first24 hours and vital parameters – HR, SBP, DBP, MAP, SpO2 ( Baseline, at induction, 5 minutes for first 10 mins and 10 mins till end of surgery will be recorded. Complications in the form of pnuemothorax, intramuscular Injection, bleeding will be recorded. Outcome variables will be: mean QoR 40 Score, mean 24hour VAS score, mean opioid consumption in first 24 hours post operatively, duration of block ( Time of administration of block to first dose of rescue analgesic).
 
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