FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056238 [Registered on: 08/08/2023] Trial Registered Prospectively
Last Modified On: 03/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparison between plain general anesthesia and ultrasound guided erector spinae plane block for postoperative pain in breast cancer surgeries 
Scientific Title of Study   A comparative study of ultrasound guided erector spinae plane block with conventional general anesthesia for postoperative analgesia in modified radical mastectomy: A prospective randomised controlled study 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kavya S 
Designation  Post graduate student 
Affiliation  Baroda medical college, vadodara 
Address  Department of Anesthesiology Gate no.4, OT Block, second floor, Baroda medical college, SSG hospital, jail road, Anandapura, vadodara.

Vadodara
GUJARAT
390001
India 
Phone  9791187041  
Fax    
Email  kavyasurishyam94@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Swati Bhatt 
Designation  Professor 
Affiliation  Baroda medical college, vadodara 
Address  Department of Anesthesiology Gate no.4, OT block, second floor, Baroda medical college, SSG hospital , jail road, Anandapura, vadodara.

Vadodara
GUJARAT
390001
India 
Phone  9879372038  
Fax    
Email  drswatibhatt2015@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DR Swati Bhatt 
Designation  Professor 
Affiliation  Baroda medical college, vadodara 
Address  Department of Anesthesiology Gate no.4, OT block, second floor, Baroda medical college, SSG hospital , jail road, Anandapura, vadodara.

Vadodara
GUJARAT
390001
India 
Phone  9879372038  
Fax    
Email  drswatibhatt2015@yahoo.com  
 
Source of Monetary or Material Support  
Baroda medical college vadodara Gujarat- 390001 
 
Primary Sponsor  
Name  Baroda medical college 
Address  Baroda medical college, SSG hospital, jail road, Anandapura, vadodara 
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 Kavya S  SSG hospital Medical college Baroda  Ward D1, COT, OT block, second floor, Department of General Surgery, Baroda medical college vadodara Gujarat - 390001
Vadodara
GUJARAT 		 9791187041

kavyasurishyam94@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Human Research and Postgraduate Research Baroda medical college and SSG hospital vadodara  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  Conventional general anesthesia  patient was preoxygenated and intubated with IV Fentanyl 2ug/kg, propofol 2mg/kg and vecuronium 0.1mg/kg. Anaesthesia was maintained with a mixture of air-oxygen and sevoflurane. ● Intraoperative fentanyl bolus given at 0.5ug/kg IV were given whenever there was a response to pain as assessed by a 20 percent increase in hemodynamic from baseline. ● And then , neuromuscular reversal was provided with 50ug/kg of neostigmine and 10ug/kg of glycopyrrolate. Patient was extubated and monitored post operatively.  
Intervention  Ultrasound guided Erector spinae plane block  Using a linear transducer probe at T4 level in sitting position with 23G spinal needle, erector spinae plane is identified and confirmed by hydro dissection. Total volume of 20ml of 0.5percent concentration levobupivacaine is injected.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  ASA – II and III
Patient posted for elective Modified Radical Mastectomy.
Patient able to give verbal and informed consent.
Patient able to understand VAS regarding assessment of pain.
 
 
ExclusionCriteria 
Details  Patient refusal
Allergy to local anaesthetics.
Patient with local site infection
Pregnant and lactating females
Patient who are unable to give consent
Patient with coagulopathy disorder
Patient with uncontrolled medical conditions like hypertension, diabetes mellitus, renal failure., etc
Patient with cardiac, renal, respiratory, neurological conditions
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of post operative analgesia between two groups.  baseline, after block, after GA, 2min, 5min,10min, 20min, 30min, 60min, 90min, 120min 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic stability
Post operative requirement of rescue analgesia if VAS more than 4
Complications associated with the block. 		 immediately postop, half hour, 1hour,2hour, 4hour, 6hour, 8hour, 12hour, 24hour 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   01/09/2023 
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="0"
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  

Our aim of study is to evaluate efficacy of Ultrasound Guided Erector Spinae Plane Block in Modified Radical Mastectomy , to compare  duration of post operative analgesia between two groups, to monitor hemodynamic changes, to observe requirement of analgesic consumption and complications.

 80 adult female patients of Age 18-65 years of ASA II , III  scheduled for Modified Radical Mastectomy will be randomised into 2 groups. Group GE (General anaesthesia + Erector Spinae Plane block) will be receiving 20 ml of 0.5% Levobupivacaine by Ultrasound Guided Erector Spinae Plane Block at T4 unilaterally in sitting position preinduction followed by general anaesthesia. Group G (General anaesthesia) will be induced by conventional general anaesthesia (Fentanyl 2mcg/kg, Propofol 2mg/kg, Vecuronium 0.1mg/kg). Hemodynamics (HR, SBP, DBP, SPO2, EtCO2) will be noted during baseline, after block and at every 20 minutes till the surgery gets completed. Fentanyl Citrate will be supplemented if there will be 20% increase in hemodynamics from baseline. Duration of post operative analgesia in 24hours , VAS score and No. of rescue analgesia will be noted.

 
Close