FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/097986 [Registered on: 24/11/2025] Trial Registered Prospectively
Last Modified On: 21/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparing pectoral chest wall nerve block versus thoracic paravertebral block for better pain relief after breast surgery. 
Scientific Title of Study   Comparison of combination of pectoral nerve block and pectointercostal fascial block versus thoracic paravertebral block for postoperative analgesia in breast surgeries. 
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 Priyanka Bansal 
Designation  Professor 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science 
Address  Department of Anaesthesiology and Critical Care, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science,Rohtak.

Rohtak
HARYANA
124001
India 
Phone  8683921867  
Fax    
Email  dr.priyankabansal1986@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rishman Kaur Tandi 
Designation  Post Graduate 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science 
Address  Department of Anaesthesiology and Critical Care, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science,Rohtak.

Rohtak
HARYANA
124001
India 
Phone  7814688442  
Fax    
Email  rishmankaur11@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Rishman Kaur Tandi 
Designation  Post Graduate 
Affiliation  Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science 
Address  Department of Anaesthesiology and Critical Care, Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science,Rohtak.

Rohtak
HARYANA
124001
India 
Phone  7814688442  
Fax    
Email  rishmankaur11@gmail.com  
 
Source of Monetary or Material Support  
Institutional- Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Science,Rohtak. pin code 124001 Haryana India 
 
Primary Sponsor  
Name  Pandit Bhagwat Dayal Sharma Institute of Medical Science 
Address  Department of Anaesthesiology and Critical Care, Pandit Bhagwat Dayal Sharma Institute of Medical Science,Rohtak. Pin-124001 Haryana.  
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 
DrRishman Kaur Tandi  Department of Anaesthesiology and Critical Care, Pt. B.D. Sharma PGIMS, Rohtak   Room no 16, Department of Anaesthesiology and Critical Care, Pandit Bhagwat Dayal Post Graduate Institute Of Medical Science. Rohtak Pin code 124001
Rohtak
HARYANA 		 7814688442

rishmankaur11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BIOMEDICAL RESEARCH ETHICS COMMITTEE  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  Pectoral nerve block and Pectointercostal fascial block  Ultrasound guided pectoral nerve block combined with pectointercostal fascial block will be performed using 0.2 percent ropivacaine. A linear ultrasound probe will be placed in the parasagittal plane in the infraclavicular area to visualise the axillary artery and vein. The probe will then be moved laterally to identify the pectoralis major, pectoralis minor, and serratus anterior muscles at the level of the third rib. A 23 gauge spinal needle will be used to inject 10 millilitres of the drug between the pectoralis minor and serratus anterior muscles and another 10 millilitres between the pectoralis major and pectoralis minor muscles. The probe will then be positioned longitudinally about two to three centimetres lateral to the sternum, and the needle will be inserted in a cephalad to caudad direction between the pectoralis major and the external intercostal muscles to deposit 10 millilitres of the drug. Adequate spread of the drug between muscle layers will confirm proper block placement. 
Comparator Agent  Thoracic paravertebral block  Ultrasound guided thoracic paravertebral block will be given using 0.2 percent ropivacaine. Patients will be placed in the lateral decubitus position with the operative side facing upward. A linear ultrasound probe with frequency range six to thirteen megahertz will be placed longitudinally at the level of the fourth thoracic vertebra and moved laterally to identify the transverse process, costotransverse ligament, paravertebral space, and pleura. A twenty three gauge spinal needle will be advanced in a cranio caudal direction to deposit twenty millilitres of the drug between the costotransverse ligament and parietal pleura. Gentle movement of the pleura during injection will confirm correct placement of the local anaesthetic. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Adult patients aged 18–60 years of either gender belonging to ASA physical status I–III scheduled for elective breast surgeries under general anesthesia.
 
 
ExclusionCriteria 
Details  1: Patients having bleeding tendency
2: Patients on Anticoagulants
3: Patients with peripheral neuropathy
4: Patients allergic to amide local anesthetics
5: Patients with mental disorder
6: Patients with local infection at injection site.
7:patients with body mass index less than 20 kilograms per square metre or more than 35 kilograms per square metre.
8.Patients who refuse to participate. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Time taken to first request of rescue analgesia.  Assessed postoperatively up to 48 hours after surgery. 
 
Secondary Outcome  
Outcome  TimePoints 
Time taken to perform the block procedure.  Intraoperative period (at time of block performance). 
Total postoperative 24-hour opioid consumption.  Within 24 hours after surgery. 
Static and dynamic visual analog score (VAS) for pain.  At PACU admission, and at 30 min, 1, 2, 4, 6, 12, 24, and 48 hours postoperatively. 
Patient satisfaction score using Likert scale.  At 24 hours postoperatively. 
Block-related complications (bleeding, hematoma, pneumothorax, nerve injury).  Intraoperatively and up to 48 hours postoperatively. 
 
Target Sample Size   Total Sample Size="70"
Sample Size from India="70" 
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)   01/06/2026 
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   This study aims to compare the postoperative analgesic benefits of combining pectoral nerve block and pectointercostal fascial block with thoracic paravertebral block in patients undergoing breast surgery. Seventy adult patients of ASA I to Ill physical status, aged 18 to 60 years, scheduled for elective breast surgeries will be enrolled. Patients will be randomly divided into two groups of thirty-five each using a computer-generated randomisation sequence. Group A will receive ultrasound-guided pectoral nerve block with pectointercostal fascial block using 0.2 percent ropivacaine, and Group B will receive ultrasound-guided thoracic paravertebral block with 0.2 percent ropivacaine. The primary objective is to determine the time to first request for rescue analgesia. Secondary objectives include time taken to perform the procedure, 24-hour postoperative opioid consumption, static and dynamic visual analog scores at different time intervals, patient satisfaction score at 24 hours, and block-related complications. The study will be conducted in the Department of Anaesthesiology and Critical Care, Pt. B.D.Sharma PGIMS, Rohtak. 
Close