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CTRI Number  CTRI/2021/03/031983 [Registered on: 15/03/2021] Trial Registered Prospectively
Last Modified On: 17/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To compare the effect of depositing drug below erector spinae and rhomboid muscles using ultrasound in relieving pain after breast cancer surgery 
Scientific Title of Study   A Comparison of ultrasound guided Erector spinae plane block versus Rhomboid intercostal block for perioperative analgesia in Breast cancer Surgery: 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  Dr Satish kumar 
Designation  Junior Resident 
Affiliation  AIIMS PATNA 
Address  Department of Anesthesiology AIIMS PATNA
PHULWARISHARIF PATNA BIHAR
Patna
BIHAR
801507
India 
Phone  8210014760  
Fax    
Email  satish.psc@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shagufta Naaz 
Designation  Associate Professor 
Affiliation  AIIMS PATNA 
Address  Department of Anesthesiology AIIMS PATNA
Phulwarisharif Patna Bihar
Patna
BIHAR
801507
India 
Phone  7765937919  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Shagufta Naaz 
Designation  Associate Professor 
Affiliation  AIIMS PATNA 
Address  Department of Anesthesiology AIIMS PATNA
Phulwarisharif Patna Bihar
Rohtas
BIHAR
801507
India 
Phone  7765937919  
Fax    
Email  drshaguftanaaz@gmail.com  
 
Source of Monetary or Material Support  
AIIMS PATNA 
 
Primary Sponsor  
Name  AIIMS PATNA 
Address  PHULWARISHARIF PATNA BIHAR PIN 801507 
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 Satish Kumar  AIIMS PATNA  Department of Anesthesiology AIIMS Patna
Patna
BIHAR 
8210014760

satish.psc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee AIIMS Patna  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  Ultrasound guided Erector spinae plane block   Ultrasound guided Erector spinae plane block will be administered after induction of general anesthesia for perioperative analgesia in breast cancer surgery. 
Comparator Agent  Ultrasound guided Rhomboid intercostal block  Ultrasound guided Rhomboid intercostal block will be administered after induction of general anesthesia for perioperative analgesia in breast cancer surgery. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Female 
Details  1.Female with breast cancer undergoing unilateral Modified Radical Mastectomy (MRM) or Breast conservative surgery with sentinel lymph node dissection.
2.American society of anesthesiologist (ASA) physical status ǀ and ǁ.
3.BMI 18-24.9 kg/m2
 
 
ExclusionCriteria 
Details  1. Patients with coagulation disorder
2. Chronic opioid use
3. Allergy to local anaesthetic
4. Procedure site infection
5. History of previous mastectomy
6. Severe spine/chest wall deformity
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Perioperative opioid consumption  From administer of the regional block to 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
1.Time of first rescue analgesia
2.NRS Pain score 
1.From 0 to 24 hours postoperatively
2.Postoperatively at 0,1,2,4,6,12 and 24 h. 
 
Target Sample Size   Total Sample Size="76"
Sample Size from India="76" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="84" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/03/2021 
Date of Study Completion (India) 30/07/2022 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Introduction:

Breast cancer is the one of the most frequently diagnosed cancers among women in the world. It is overall the second most common cancer in the world. Now it has  become the most common cancer among women in the developing world.1 Treatment modality for breast cancer includes  primarily surgery (mastectomy), with or without chemotherapy, and/or radiotherapy  but severe acute postoperative pain is a high concern for approximately half of all breast surgery patients.2 For a long time, various regional anesthesia techniques including thoracic paravertebral block, Erector spinae plane block, Pecs block etc has been used for perioperative analgesia in breast cancer surgery to decrease opioid consumption and its side effect.

Following endotracheal intubation, patients in the group A will be positioned in lateral decubitus with the involved breast lying superiorly. The spine will be palpated from C7 (most prominent spinous process) to T5 and point will be marked to identify the spinous process. Ultrasound-guided EPSB will be performed by Paramedian sagittal scan with in-plane needle insertion from cranial to caudal.

Following endotracheal intubation, patients in the group B will be positioned in lateral decubitus with the involved breast lying superiorly. The ipsilateral arm will be moved across the chest to move the scapula away and open up the triangle of auscultation (TOA) space (Figure 2). The TOA is located along the lower medial border of the scapula. It is bounded superiorly by the trapezius, inferiorly by the latissimus dorsi, and laterally by the vertebral border of the scapula. Rhomboid intercostal block will be performed aseptically by an anaesthesiologist experienced with the performance of RIB. 


·         Problem statement:

Breast cancer surgery is associated with acute and chronic postoperative pain which is a significant concern. Inadequate postoperative pain control may hamper early recovery and discharge. High dose of opioid consumption for perioperative analgesia in breast cancer surgery increases PONV, tolerance and respiratory depression and may delay recovery. Therefore, effective and safe multimodal analgesia is required to control postoperative acute pain and reduce opioid consumption.

·         Rationale–

 Ultrasound guided ESPB and RIB are effective, safe and new regional block techniques for  postoperative analgesia to control acute postoperative pain which help in early recovery and patient satisfaction which is a significant concern in breast cancer surgery. Both reduce postoperative opioid consumption and their side effects. But it is not known which among the two has better analgesic efficacy.

·         Novelty -

Currently many regional block techniques are in practice for perioperative analgesia in breast cancer surgery but none of them can be considered as gold standard. Ultrasound guided ESPB and RIB are relatively new  and safe regional blocks for major thoracic surgery. This study is one of its kind in which we will compare perioperative analgesic efficacy of the two blocks.

·         Research question:  Does ultrasound guided ESPB provide more effective perioperative analgesia   than RIB in breast cancer surgery?

·         Research hypothesis: Ultrasound guided ESPB provides more effective perioperative analgesia than RIB in breast cancer surgery.

·         Aim – To compare ultrasound guided Erector spinae plane block versus Rhomboid intercostal block for perioperative analgesia in breast cancer surgery.

 

·         Primary Objective:

 To compare opioid consumption between ultrasound guided ESPB versus RIB for perioperative analgesia in breast cancer surgery.

·         Secondary Objective :

1.      To compare the time to first rescue analgesia.

2.      To compare postoperative pain score at 0,1,2,4,6,12 and 24 h.

 
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