FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2019/06/019579 [Registered on: 07/06/2019] Trial Registered Prospectively
Last Modified On: 09/06/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of erector spinae block under sedation and general anesthesia on postopertaive recovery in patients undergoing breast brachytherapy 
Scientific Title of Study   Single-injection ultrasound guided erector spinae block compared to general anaesthesia in in patients undergoing Accelerated Partial Breast Irradiation-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  NISHKARSH GUPTA 
Designation  Associate Professor 
Affiliation  AIIMS 
Address  Department of Onco-Anesthesiology and Palliative Medicine Room no. 139, 1st floor, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi DELHI 110029 India

South
DELHI
110029
India 
Phone  09013310014  
Fax    
Email  drnishkarsh@rediffmail.com  
 
Details of Contact Person
Scientific Query
 
Name  NISHKARSH GUPTA 
Designation  Associate Professor 
Affiliation  AIIMS 
Address  Department of Onco-Anesthesiology and Palliative Medicine Room no. 139, 1st floor, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi DELHI 110029 India

South
DELHI
110029
India 
Phone  09013310014  
Fax    
Email  drnishkarsh@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  NISHKARSH GUPTA 
Designation  Associate Professor 
Affiliation  AIIMS 
Address  Department of Onco-Anesthesiology and Palliative Medicine Room no. 139, 1st floor, Dr B.R. Ambedkar Institute Rotary Cancer Hospital, AIIMS, New Delhi DELHI 110029 India
110029 India
South
DELHI
110029
India 
Phone  09013310014  
Fax    
Email  drnishkarsh@rediffmail.com  
 
Source of Monetary or Material Support  
Department of Onco-Anesthesiology and Palliative Medicine, DRBRAIRCH,AIIMS 
 
Primary Sponsor  
Name  AIIMS New Delhi 
Address  Room No 139, 1st floor, Dr B.R.A. Institute Rotary Cancer Hospital, AIIMS, Delhi, 110029  
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 
Nishkarsh Gupta  Department of Onco-Anesthesiology and Palliative Medicine  Room No 139, DRBRAIRCH, AIIMS New Delhi DELHI
South
DELHI 
9013310014

drnishkarsh@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee (AIIMS)   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group ESPB  Accelerated Partial Breast Irradiation under MAC along with ESPB block using 0.5% Ropivacaine (with a maximum volume of 30ml). 
Comparator Agent  Group GA  Accelerated Partial Breast Irradiation under general anaesthesia  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  Clinical diagnosis of early stage breast cancer for APBI.
ASA Physical status I, II, III
 
 
ExclusionCriteria 
Details  a. Patients Refusal
b. Patients with infection at the site of ESPB.
c. Patients with severe chest wall deformity.
d. Patients with history suggestive of coagulopathy or receiving any anticoagulants.
e. Presence of complications like mental illness, severe heart disease (NYHA classification ≥3), any renal or hepatic disorder before surgery. f. Allergic to any drug being used during the study.
 
 
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 
Discharge from PACU as assessed by PADSS more than equal to 9 after end of surgery.   Discharge from PACU as assessed by PADSS more than equal to 9 at regular intervals time 0,1,2,4 hrs. 
 
Secondary Outcome  
Outcome  TimePoints 
Postoperative pain VAS score
Postoperative Nausea vomiting( VAS score 30 mm)
Sore throat.
Analgesic medication
Antimemetic medication
Oxygen supplementation
Hemodynamic and respiratory profiles
Satisfaction score 
At time zero,30 minutes, and 1,2,8 and 24 hrs after completion of surgery.  
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   10/06/2019 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Breast cancer is a worldwide problem, accounting for 10.4% of all cancer incidence among women, making it the second most common type of non-skin cancer (after lung cancer) and the fifth most common cause of cancer death. The ‘surveillance, epidemiology and end results’ (SEER) program reported that in 2006, 60% of diagnosed breast cancers are early stage. The management of early-stage breast cancer includes  breast-conserving surgery (such as lumpectomy), a mastectomy (also called a modified radical mastectomy), radiation therapy and systemic treatments.

Despite the advantages of BCT, its utilization remains a problem due to convenience, access, cost and other logistical issues. In APBI, radiation can be delivered in a significantly shortened period, thereby potentially making the BCT option available and attractive to more women. APBI can be done under either local anaesthesia, general anaesthesia or regional blocks with sedation. Breast cancer surgery, such as mastectomy or lumpectomy with or without axillary lymph node dissection/biopsy, has frequently been performed using general anesthesia (GA). However, GA is associated with a high incidence of postoperative nausea and vomiting (PONV) that not only reduces patient satisfaction but also delays patient recovery after breast surgery. Recently, breast cancer surgery has often been performed under regional anesthesia techniques like Paravertebral block (PVB), erector spinae block etc.   A recent metaanalysis demonstrated that thoracic PVB has several advantages, such as better postoperative pain control, lower incidence of PONV, shorter recovery time and higher patient satisfaction, compared with GA alone in breast surgery.  To our knowledge, however, there are no reports of studies comparing GA with Erector Spinae block for Accelerated Partial Breast Irradiation. The first purpose of this study is to   compare these two anesthesia techniques in terms of post-anesthesia recovery time. Our  secondary aim was to compare perioperative hemodynamics because decreasing blood pressure is often observed during GA. We hypothesized that performing the procedure under  Erector Spinae block could facilitate postoperative recovery and avoid hypotension during anesthesia.


 
Close