| CTRI Number |
CTRI/2025/04/085901 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of various volumes of local anaesthestic in interfascial plane blocks for breast surgery |
|
Scientific Title of Study
|
Volume study of superficial serratus plane block for breast surgeries: a prospective randomized 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 |
Tejas Vijay Wagh |
| Designation |
Fellow Doctor |
| Affiliation |
Ruby hall clinic |
| Address |
Cancer biulding 7th floor, department of anaesthesia , Ruby hall clinic , 40, sassoon road , pune
40,Sassoon Road,Pune - 411001
Pune
MAHARASHTRA
444005
India |
| Phone |
9403139327 |
| Fax |
|
| Email |
tejaswaghr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nita DSouza |
| Designation |
Senior consultant doctor |
| Affiliation |
Ruby hall clinic |
| Address |
Department of Anaesthesia, Ruby hall clinic, 40,Sassoon Road,Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9823721982 |
| Fax |
|
| Email |
drnita610@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Nita DSouza |
| Designation |
Senior consultant doctor |
| Affiliation |
Ruby hall clinic |
| Address |
Department of Anaesthesia, Ruby hall clinic, 40,Sassoon Road,Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9823721982 |
| Fax |
|
| Email |
drnita610@yahoo.com |
|
|
Source of Monetary or Material Support
|
| RUBY HALL CLINIC , PUNE IS THE PLACE OF RESEARCH. NO SEPARATE FUNDING FOR THE STUDY |
|
|
Primary Sponsor
|
| Name |
Ruby hall clinic |
| Address |
40 ,Sasoon Road, Pune |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tejas Wagh |
Ruby hall clinic |
Department of Anaesthesia, Ruby hall clinic ,40,Sassoon Road, Pune
411001
Pune
MAHARASHTRA |
9403139327
tejaswaghr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Poona medical research foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ropivacaine 0.2% with volume of 20ml, 25ml,30ml |
group 1 : superficial serratus plane with drug volume 20ml.
group 2 : superficial serratus plane with drug volume 25ml.
group 3 : superficial serratus plane with drug volume 30ml. |
| Intervention |
volume studies of superficial serratus plane block |
assessment of pain over 24 hours using 0.2% ropivacaine using different drug volumes. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
All adult female patients for elective surgery under general anaesthesia coming under physical status ASA1 and 2. |
|
| ExclusionCriteria |
| Details |
No consent and cooperation for the procedure,
Allergy to any drugs used in the study,
Weight less than 50 kg or obesity bmimore than 35kg per m
Liver disease, renal disease, arrhythmia
Chronic pain
Neuromuscular disease
Pregnancy |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of volume in analgesic efficacy of superficial serratus plane block in breast surgery |
ANALGESIC EFFECT ACCESSED AT 0, 3, 6,12,18,24 HOURS. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Adverse events & their role in chronic pain |
AFTER 1 WEEK AND 3 MONTHS OF SURFERY |
|
|
Target Sample Size
|
Total Sample Size="36"
Sample Size from India="36"
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)
|
10/05/2025 |
| 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="0"
Months="8"
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
|
Serratus plane block (SPB) was introduced by Blanco et al , is a novel form of ultrasound-guided regional anaesthesia fascial plane block that can achieve paraesthesia of the hemithorax. Surgery on the chest wall is relatively common and can be associated with considerable postoperative discomfort and pain. Breast cancer has continued to be the most common cancer afflicting women, accounting for 31% of all new cancer cases in the female population . Every year, thousands of patients undergo surgery in the region of the breast and axilla. These procedures cause significant acute pain and may progress to chronic pain states in 25–60% of cases . Blockade of the lateral cutaneous branches of the thoracic intercostal nerves (T2–T12) will provide analgesia to the anterolateral chest wall in this patient population . This fascial plane block has become popular in recent years because of its ease of performance as compared with thoracic epidural or paravertebral block. Its analgesic effectiveness has been reported for mastectomies, thoracotomies, rib fractures, and chest drain insertions. Previous cadaveric studies have examined the extent of dye spread and the nerves involved. However, the optimal plane and volume of injection for maximal spread in the anterior chest wall and axilla have not been evaluated. There has been limited study concerning the appropriate volume for this block . Hence our goal of this study is to evaluate the impact of volume, level, and site of injection on the extent of injectate spread that can influence analgesic coverage and role in chronic pain management. |