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CTRI Number  CTRI/2024/05/067143 [Registered on: 10/05/2024] Trial Registered Prospectively
Last Modified On: 03/05/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare two methods of perioperative pain relief in patients undergoing breast surgery 
Scientific Title of Study   Comparison between costotransvere block and erector spinae plane block for perioperative analgesia in patients undergoing modified radical mastectomy -A prospective randomised double blinded trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aanchal Bharuka 
Designation  Consultant Anaesthesiologist 
Affiliation  Basavatarakam Indo-American Cancer Hospital and Research Institute,Hyderabad 
Address  Department of Onco-Anaesthesiology, Pain And Palliative Medicine, Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills Road no 10, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  8978185520  
Fax    
Email  doc.aanchalb@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Aanchal Bharuka 
Designation  Consultant Anaesthesiologist 
Affiliation  Basavatarakam Indo-American Cancer Hospital and Research Institute,Hyderabad 
Address  Department of Onco-Anesthesiology, Pain and Palliative Medicine ,Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills Road no 10, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  8978185520  
Fax    
Email  doc.aanchalb@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aanchal Bhrauka 
Designation  Consultant Anaesthesiologist 
Affiliation  Basavatarakam Indo-American Cancer Hospital and Research Institute,Hyderabad 
Address  Department of Onco-Anesthesiology, Pain and Palliative Medicine, Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills, Road no 10, Hyderabad

Hyderabad
TELANGANA
500034
India 
Phone  8978185520  
Fax    
Email  doc.aanchalb@gmail.com  
 
Source of Monetary or Material Support  
Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills, Road no 10, Hyderbad -500034,Telangana, India 
 
Primary Sponsor  
Name  Dr Aanchal Bharuka 
Address  Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills, Road no 10, Hyderbad -500034,Telangana, India 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
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 Aanchal Bharuka  Basavatarakam Indo-American Cancer Hospital and Research Institute  Department of Onco-Anesthesiology, Pain and Palliative Medicine, Block 1, Fourth Floor, Basavatarakam Indo-American Cancer Hospital and Research Institute, Banjara Hills, Road no 10, Hyderabad -500034, Telangana, India
Hyderabad
TELANGANA 
8978185520

doc.aanchalb@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee BIACHRI  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 
Intervention  Costo-transverse block   A high frequency linear USG transducer will be placed 2-2.5cm lateral to the spinous process of the 4th thoracic vertebra. CTB block will be performed unilaterally on the ipsilateral side of surgery. The skin and subcutaneous layers, trapezius and erector spinae muscles, third and fourth transverse processes, intertransverse and superior costotransverse ligaments (SCTL) as well as the pleura will be placed in the field of view. A needle will be advanced parallel to the SCTL, will be stopped immediately before reaching the cranial part of the fourth rib. Here, 25ml 0.5% bupivacaine will be injected. In-plane technique will be used and the needle will be advanced cephalo-caudally. 
Comparator Agent  Erector spinae plane block  A linear high‐frequency US probe will be used for performing the block, which will be placed in craniocaudal orientation in the midline. The probe will then be moved laterally to identify T4 transverse process (TP), which is usually at 2.5–3 cm from spinous process laterally. ESM, rhomboidus major, and trapezius muscle will be identified.A 10 cm block needle will be introduced in‐plane craniocaudally under vision and navigated till the TP is encountered. Hydro dissection with 2 ml normal saline will be done to confirm separation of ESM from TP. Under US guidance, 25ml 0.25 % bupivacaine will be injected and drug spread will be seen in the ESP plane craniocaudally in real time.  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  ASA 1 2 3
BMI LESS THAN 35
SURGERY MRM 
 
ExclusionCriteria 
Details  PATIENT REFUSAL
AGE LESS THAN 25YEARS AND MORE THAN 65 YERAS
ASA 4
BMI MORE THAN 35
LOCAL ANESTHETIC ALLERY
INFECTION AT THE INFECTION SITE
COAGULOPATHY
RENAL DYSFUNCTION
HEPATIC DYSFUNCTION
 
 
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 
to compare the analgesic efficacy for post operative pain management with respect to 24hr morphine consumptiom  0,30,60,90,120 mins
4,6,8,12,16,20,24 hrs
 
 
Secondary Outcome  
Outcome  TimePoints 
1.to assess and compare time required to perform the block
2.to assess and compare intraoperative hemodynamics - before ansd after skin incision
3.to assess and compare intraoperative fentanyl consumption
4.to assess and compare intraoperative complication between both groups  
before skin incision, after skin incision
30,60,90,120,150 mins 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   20/05/2024 
Date of Study Completion (India) 20/03/2025 
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)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [doc.aanchalb@gmail.com].

  6. For how long will this data be available start date provided 01-10-2025 and end date provided 01-10-2030?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

INTRODUCTION

 

There is an increasing incidence of cancer and breast cancer is the most common cancer in women accounting to 25.8 per 100,000 women, in India1.  Surgery remains the prime modality of treatment for these patients. About 10-20% of surgical patients experience acute post-operative pain, which may progress to post mastectomy pain syndrome in 25-60% patients if adequate pain relief is not provided2.

Regional anesthesia techniques provide excellent perioperative analgesia 3and also reduce post-operative nausea, vomiting.  Several regional anaesthesia techniques have been described for perioperative analgesia, however no single technique is proven better than the other. Erector spinae plane block and costo-transverse plane block are recent additions under US guided posterior thoracic blocks. Seelam et al used US guided ESPB for female patients undergoing modified radical mastectomy and evaluated its analgesic efficacy in reducing perioperative pain4. Nielsen et al in his cadaveric study, described US guided costo- transverse block as relatively new peri-paravertebral block. They checked for spread of injected dye in this block and erector spinae plane block5. The spread of local anaesthetic in costotransverse block involved better spread to ventral ramus than erector spinae plane block which possibly will give better analgesia.

Methodology :After obtaining written informed consent computer generated randomization will be done. Patients will be  randomized to receive either a single‐shot US‐guided ESPB (ESP group) or single-shot US- guided costo transverse block After confirming nil by mouth status , patients will be wheeled in operation room and ASA standard monitors will be connected. General anaesthesia using iv Xylocard 1.5 mg/kg ,iv Fentanyl 2mcg/kg (ideal body weight ), iv Propofol 1.5 -2mg/kg.and  neuromuscular block will be achieved with  atracurium 0.5mg/kg. Airway will be secured with an appropriately sized Supraglottic airway/ ETT General anesthesia will be maintained with oxygen- medical air and Sevoflurane using volume controlled ventilation and dial concentration adjusted to target end tidal concentration of  isoflurane of 1.2 .Dexamethasone 0.1mg/kg,  iv Magnesium 40mgs/kg, iv Paracetamol 20mg/kg (maximum 1 gm) will be given after induction.as a part of multimodal analgesia. Post induction patients will be placed in lateral decubitus position and as per group allocated either US guided  ESPB or US guided costo transverse block will be performed . Fentanyl 0.5 mcg/kg (maximum 50 mcg) will be administered to all the patients who have a sympathetic response to pain on incision i.e. if the heart rate and blood pressure is raised by at least 20% of baseline. Post extubation patient will be shifted to a high‐dependency unit. The Numerical rating scale will be used to assess pain postoperatively. Intravenous paracetamol 1 g every 8 h will be continued in the postoperative period. Intravenous morphine will be used as rescue analgesic in both groups, if the NRS score was more than 4, 3mg iv morphine will be administered, and patient will be reassessed after 15 mins. If NRS is more than 4 a repeat dose of 3mg of morphine will be given.

US‐guided ESPB technique :A linear array high‐frequency US probe (GE VENUE GO TM) will be used for performing the block, which will be placed in craniocaudal orientation in the midline. The probe will then be moved laterally to identify T4 transverse process (TP), which is usually at 2.5–3 cm from spinous process laterally. ESM, rhomboidus major, and trapezius muscle will be identified. Under aseptic precautions 10 cm block needle (StimuplexUltra 36022 G, B‐Braun) will be introduced in‐plane craniocaudally under vision and navigated till the TP is encountered. Hydro dissection with 2 ml normal saline will be done to confirm separation of ESM from TP. Under US guidance, 25ml 0.5% bupivacaine will be injected and drug spread will be seen in the ESP plane craniocaudally in real time.

USG guided CTB block :A high frequency linear USG transducer will be placed 2-2.5cm lateral to the spinous process of the 4th thoracic vertebra. CTB block will be performed unilaterally on the ipsilateral side of surgery. The skin and subcutaneous layers, trapezius and erector spinae muscles, third and fourth transverse processes, intertransverse and superior costotransverse ligaments (SCTL) as well as the pleura will be placed in the field of view. A needle will be advanced parallel to the SCTL, will be stopped immediately before reaching the cranial part of the fourth rib. In-plane technique will be used  and the needle will be advanced  cephalo-caudally. Here, 25ml 0.5% bupivacaine will be injected.

 


 
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