| CTRI Number |
CTRI/2024/07/070334 [Registered on: 09/07/2024] Trial Registered Prospectively |
| Last Modified On: |
07/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Ultrasound guided pectoral block versus erector spinae block for post operative analgesia of breast surgeries |
|
Scientific Title of Study
|
A Comparative Study Of Pectoral Nerve Versus Erector Spinae Block Using Ultrasound Guided Technique For Post Operative Analgesia of 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 |
Gedela sushma |
| Designation |
Post graduate |
| Affiliation |
Rangaraya medical college |
| Address |
Department of Anaesthesiology
Rangaraya Medical College
GGH,Kakinada
East Godavari
ANDHRA PRADESH
500001
India |
| Phone |
9490868061 |
| Fax |
|
| Email |
gedelasushma1348@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.K.Vindhya |
| Designation |
Professor |
| Affiliation |
Rangaraya medical college |
| Address |
Department Of Anesthesiology
Rangaraya MedicalCollege,Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
7702479295 |
| Fax |
|
| Email |
Vindhyakakula@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Gedela Sushma |
| Designation |
Post graduate |
| Affiliation |
Rangaraya medical college |
| Address |
Department Of Anesthesiology
Rangaraya Medical College,
Kakinada
East Godavari
ANDHRA PRADESH
533001
India |
| Phone |
9490868061 |
| Fax |
|
| Email |
gedelasushma1348@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gedela Sushma
Rangaraya medical college,
Kakinada,
Andhrapradesh,India
533001 |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology Rangaraya medical college |
| Address |
Rangaraya medical college,
Government general hospital,Kakinada
|
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrSushma Gedela |
Rangaraya medical college |
Department of Anaesthesiology,
Government General Hospital,
Kakinada
East Godavari
ANDHRA PRADESH |
9490868061
Gedelasushma1348@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RANGARAYA MEDICAL COLLEGE INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector spinae block using 0.2% ropivacaine 25cc |
Postoperative analgesia for breast surgeries
Patient in sitting position see right lateral tip of T4 transverse process high frequency linear probe positioned in transverse orientation locate 3 muscles trapezius,rhomboid major,erector spinae
Block needle placed cephalo caudal orientation to contact transverse process after 2ml 2% lignocaine injected
Dose of 25ml of 0.2% ropivacaine given linear spread that lifted the erector spinae muscle off the underlying transverse process and inter coastal muscles suggested right location |
| Intervention |
Pectoral nerve block using 0.2% ropivacaine 25cc |
For analgesia in Breast surgeries
0.2%ropivacaine 25ml
Patient in supine with arm abducted on side of operation
Axillary artery an vein located using ultrasound
Needle placed obliquely until tip seen between serratus anterior and pectoralis minor 15 ml 0.2% ropivacaine deposited
After needle removed till tip between pectoralis major and minor 10ml 0.2% ropivacaine deposited
Monitor for 30min pinprick sensation to measure the block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
All patients in the above age group in ASA grade 1,2 who have been scheduled for breast surgeries will be included |
|
| ExclusionCriteria |
| Details |
Patients scheduled for breast surgeries
Patients suffering from psychiatric disorders
Who are not willing to participate in the study
Patients having BMI more than 40 |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Numerical rating scale NRS (1 to 10) 1 to 3 — mild 4 to 6 — moderate 7 to 10–severe after block,in both intervention and control group. |
Postoperative pain by using NRS(0-10,0- no pain and 10–worst pain possible) every 30min till 24 hours.
time points will be sequentially 30 min until 24 hrs of block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative narcotic used in both groups |
Till 24hrs after surgery |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
24/07/2024 |
| 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="6"
Days="1" |
|
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
|
Achieving adequate perioperative analgesia can be challenging in patients undergoing breast surgeries. Earlier THORACIC EPIDURAL and PARAVERTEBRAL BLOCK were considered gold standard analgesic techniques till date. These techniques may be associated with problems like pneumothorax, vascular puncture, nerve damage. Alternative to these blocks some newer techniques have been designed with better safety profile and comparable pain relief. Pectoral (PECs) block is one of them in which the drug is deposited into the inter-fascial plane between pectoralis major and minor/pectoralis minor and serratus anterior muscles. There has been only a single study comparing both of these blocks in these surgeries,but none in the Indian subpopulation. We hypotthesised that ESP block can be as effective as PECS block for MRM patients in terms of perioperative analgesia. The primary objective was to compare morphine consumption in 24 hours postoperatively. |