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CTRI Number  CTRI/2024/07/070122 [Registered on: 05/07/2024] Trial Registered Prospectively
Last Modified On: 03/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to compare serratus posterior superior intercostal plane block and serratus anterior plane block for pain relief after surgery in patients undergoing breast surgeries for cancer 
Scientific Title of Study   Comparison between ultrasound guided serratus posterior superior intercostal plane block and serratus anterior plane block for post-operative analgesia in patients undergoing modified radical mastectomy- A 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  Dr Sonam Sachdeva 
Designation  Post graduate student  
Affiliation  Lady hardinge medical College and associated hospitals, New Delhi 
Address  Department of anaesthesia, Lady Hardinge Medical College, Shahid Bhagat Singh Marg, New Delhi, India

New Delhi
DELHI
110001
India 
Phone  8963960218  
Fax    
Email  sonamsachdeva1234@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Maitree Pandey 
Designation  Director Professor & Head of department of anaesthesia  
Affiliation  Lady hardinge medical college and associated hospitals , New Delhi 
Address  Department of anaesthesia, Lady Hardinge Medical College, Shahid Bhagat Singh Marg, New Delhi, India

New Delhi
DELHI
110001
India 
Phone  9810570515  
Fax    
Email  maitreepandey@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Nishant Kumar 
Designation  Professor 
Affiliation  Lady hardinge medical College and associated hospitals, New Delhi 
Address  Department of anaesthesia, Lady Hardinge Medical College, Shahid Bhagat Singh Marg, New Delhi, India

New Delhi
DELHI
110001
India 
Phone  9811934659  
Fax    
Email  kumarnishant@yahoo.co.uk  
 
Source of Monetary or Material Support  
Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, cannaught place, New Delhi, India 110001 
 
Primary Sponsor  
Name  Lady Hardinge Medical College and associated hospitals New Delhi Indiia 
Address  Lady Hardinge Medical College and associated hospitals, Shaheed Bhagat Singh Marg, cannaught place, New Delhi, India 110001 
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 Sonam Sachdeva   Lady Hardinge Medical College and associated hospitals, New Delhi  Department of anaesthesia, new academic block, room no. 512, Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, New Delhi, India 110001
New Delhi
DELHI 		 8963960218

sonamsachdeva1234@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, LHMC and associated hospitals   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, (2) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  serratus anterior plane block  In serratus anterior plane block (SAPB), usg guided 30 ml of 0.25% injection levo-bupivacaine will be injected anteriorly to the serratus anterior in the plane created with the latissimus dorsi muscle once before induction of anaesthesia 
Intervention  serratus posterior superior intercostal plane block  In serratus posterior superior intercostal plane block (SPSIPB) usg guided 30 ml of 0.25% levo-bupivacaine will be administered between serratus posterior superior muscle and intercostal muscles once before induction of anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1.ASA I- III
2.Patients undergoing modified radical mastectomy  
 
ExclusionCriteria 
Details  1.Patients with contraindications like coagulopathy, bleeding diathesis and local infections at the block administration site
2.Patients with known local anesthetic drug allergies

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare post-operative analgesia (24hour opioid consumption) between ultrasound guided serratus posterior superior intercostal plane block and serratus anterior plane block in patients undergoing MRM (modified radical mastectomy).
 		 First 24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.The time taken to perform the block
2.Total number of skin punctures to perform the block
3.Duration of analgesia(in minutes)
4.Static and dynamic pain scores( NRS SCale)
5.Number of complications related to block.
6. Quality of recovery
7.patients and surgeons satisfaction (by Likert Scale) 
1.Static and dynamic pain scores at 0,3,6,12 and 24 hours.
2. Duration of analgesia in first 24 hours after surgery.
3.patients developing complications in first 24 hours after sugery
4. Quality of recovery within first 24 hours after surgery
5.patients and surgeons satisfaction within 24 hours after surgery.

 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   15/07/2024 
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="1"
Days="21" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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   Surgical interventions for breast cancer including breast conservation surgery, modified radical mastectomy (MRM) and lumpectomy are widespread due to the high incidence of breast cancer globally. These surgeries are essential components of breast cancer treatment. Since it affects the postoperative recovery and mobilization, pain after breast surgery is an important issue. Breast surgery presents unique pain challenges due to the complexity of the breast anatomy and the potential for extensive tissue manipulation and ineffective pain relief by oral analgesics, necessitating the exploration of advanced regional anesthesia techniques.
These include thoracic epidural or paravertebral block, intercostal nerve block, pectoral nerve blocks and the newer USG guided fascial plane blocks like erector spinae plane block (ESPB), rhomboid intercostal plane block (RIPB), serratus anterior plane block (SAPB) and Serratus posterior superior intercostal plane block (SPSIPB).
Serratus anterior plane block (SAPB) was first proposed by Blanco et al in 2013, and provides good postoperative analgesia after MRM. It blocks T2-T9 intercostal nerves and provides analgesia over the chest wall and axillary region.3 
Recently an interfascial plane block technique: Serratus posterior superior intercostal plane block has been described. It is performed between serratus posterior superior muscle (SPSm) which is a periscapular muscle and intercostal muscles. Due to its features, injecting local anesthetic (LA) deeply into the SPSm results in coverage of dorsal ramus and lateral cutaneous branches of intercostal nerves at C3 to T10 levels. Given SPSIPB’s sensory dermatome, it has been demonstrated that it can provide analgesia in the hemithorax, shoulder, and back of the neck.
Although SAPB is a proven and efficacious method for providing effective post operative analgesia in patients undergoing MRM, breast cancers associated with fungating mass, local infection and inflammation may pose challenges to perform SAPB. Given SPSIPB’s sensory dermatome, it may provide analgesia for surgical procedures involving the breast. There is paucity of studies on the role of SPSIPB in pain control on breast surgeries. Therefore this study is being planned to compare the postoperative analgesia provided by the two blocks in patients undergoing MRM.
 
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