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CTRI Number  CTRI/2024/10/074993 [Registered on: 09/10/2024] Trial Registered Prospectively
Last Modified On: 08/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparative study of ultrasound guided pectoral nerve block verus paravertebral block for post operative pain relief in carcinoma breast surgeries. 
Scientific Title of Study   Comparative study of ultrasound guided pectoral nerve block verus paravertebral block for post operative analgesia in carcinoma 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  Subash TS 
Designation  Post Graduate 
Affiliation  Vinayaka Missions medical college and hospital 
Address  OT complex first floor, department of anaesthesiology Vinayaka Missions medical college and hospital Kottuchery Karaikal

Karaikal
PONDICHERRY
609609
India 
Phone  7010567129  
Fax    
Email  subashkumarr66@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Cheran K 
Designation  Professor 
Affiliation  Vinayaka Missions medical college and hospital 
Address  OT complex first floor, department of anaesthesiology Vinayaka Missions medical college and hospital Kottuchery Karaikal

Karaikal
PONDICHERRY
609609
India 
Phone  9443144652  
Fax    
Email  anscheran.k73@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Subash TS 
Designation  Post-Graduate 
Affiliation  Vinayaka Missions medical college and hospital 
Address  OT complex first floor, department of anaesthesiology Vinayaka Missions medical college and hospital Kottuchery Karaikal

Karaikal
PONDICHERRY
609609
India 
Phone  7010567129  
Fax    
Email  subashkumarr66@gmail.com  
 
Source of Monetary or Material Support  
OT complex first floor, department of anaesthesiology Vinayaka Missions medical college and hospital Kottuchery Karaikal Pondicherry India Pincode 609609 
 
Primary Sponsor  
Name  Subash TS 
Address  OT complex first floor, department of anaesthesiology Vinayaka Missions medical college and hospital Kottuchery Karaikal Pondicherry India Pincode 609609 
Type of Sponsor  Other [Self] 
 
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 Subash TS  Vinayaka Missions medical college and hospital  OT complex first floor, department of anaesthesiology
Karaikal
PONDICHERRY 
7200701094

subashkumarr66@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Vinyaka missions medical college and hospital  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 
Comparator Agent  NIL  NIL 
Intervention  Paravertebral block  Under USG guidance,Paravertebral block given once using 20ml of 0.25Percentage Bupivacaine local anaesthetic before induction of anaesthesia 
Intervention  Pectoral Nerve block  Under USG guidance,Pectoral nerve block given once using 20ml of 0.25Percentage Bupivacaine local anaesthetic before induction of anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  Patients undergoing carcinoma breast surgery 
 
ExclusionCriteria 
Details  Pregnant female and lactating mother,
patients Allergic to local anaesthesia,
patients with Coagulopathy 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the duration of blockade and recovery in the postoperative period between pectoral nerve block and paravertebral block in patient undergoing carcinoma breast surgeries.  24 Hours 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the time taken for rescue analgesia dose requirements,
To monitor Haemodynamic parameter in post operative period 
24 hours 
 
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   Phase 4 
Date of First Enrollment (India)   20/10/2024 
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="6"
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  

General anesthesia (GA) is by far the most common utility used for breast surgeries. Different regional techniques have been tried during breast surgery, including thoracic epidural, thoracic paravertebral block, thoracic spinal block and Pecs block.


This study compares postoperative analgesia between ultrasound-guided pectoral nerve block and paravertebral block in carcinoma breast surgeries performed under general anesthesia (GA). Here’s a breakdown: 1. Ethical Approval: The study begins with obtaining approval from an ethical committee, ensuring that the research meets ethical standards. 2. Informed Consent: Informed written consent is obtained from each patient, ensuring they understand the study’s purpose, procedures, and risks. 3. Inclusion and Exclusion Criteria: Criteria are established to select eligible patients for the study, ensuring they meet specific characteristics while excluding those with factors that could confound the results. 4. Patient Selection: Patients with an indication for breast surgery are selected for inclusion in the study. 5. Randomization: Patients undergoing breast surgery under general anesthesia are randomly assigned to one of two groups: Group A receives a pectoral nerve block, while Group B receives a paravertebral block. 6. Postoperative Assessment: Following surgery, both sensory and motor assessments are conducted at regular intervals (every 30 minutes) until the complete regression of the block is observed. This allows for monitoring the duration and effectiveness of each nerve block technique. 7. Pain Assessment: Postoperative pain is assessed using the Visual Analog Scale (VAS), a commonly used tool for subjective pain evaluation. 8. Objective: The primary objective of the study is to compare the efficacy of ultrasound-guided pectoral nerve block versus paravertebral block in providing postoperative analgesia for carcinoma breast surgeries performed under general anesthesia.


 
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