| CTRI Number |
CTRI/2025/09/094249 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare two types of ultrasound-guided nerve blocks for better pain relief in non-cancer breast surgery |
|
Scientific Title of Study
|
Comparison of postoperative analgesic efficacy of ultrasound guided modified pectoralis plane block and serratus anterior plane block in benign breast surgery – A randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PDEVISRI |
| Designation |
POST GRADUATE |
| Affiliation |
Sri manakulla vinayagar medical college |
| Address |
Room 106 department of anaesthesialogy sri manakula vinayagar medical college kalitheertalkuppam,Madagadipet ,puducherry
Room 106 department of anaesthesialogy sri manakula vinayagar medical college kalitheertalkuppam,Madagadipet ,puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9080154167 |
| Fax |
|
| Email |
devisridear@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagalakshmi |
| Designation |
professor |
| Affiliation |
Sri manakulla vinayagar medical college |
| Address |
Room 107 department of anaesthesialogy sri manakula vinayagar medical college kalitheertalkuppam,Madagadipet ,puducherry
Room 107 department of anaesthesialogy sri manakula vinayagar medical college kalitheertalkuppam,Madagadipet ,puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894510137 |
| Fax |
|
| Email |
vedha83@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nagalakshmi |
| Designation |
professor |
| Affiliation |
Sri manakulla vinayagar medical college |
| Address |
Room 107 department of anaesthesialogy sri manakula vinayagar medical college kalitheertalkuppam,Madagadipet ,puducherry
Room 107 department of anaesthesialogy sri manakula vinayagar medical college kalitheertalkuppam,Madagadipet ,puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9894510137 |
| Fax |
|
| Email |
vedha83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri manakula vinayagar medical college ,kalitheerthalkuppam,puducherry 605107 |
|
|
Primary Sponsor
|
| Name |
sri manakulla vinayagar medical college |
| Address |
No 106,Sri manakulla vinayagar medical college hospital,kalitheerthalkuppam ,puducherry 605107 |
| Type of Sponsor |
Other [self] |
|
|
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 |
| PDEVISRI |
Sri manakulla vinayagar college |
Room 106 department of anaesthesialogy sri manakula vinayagar medical college kalitheertalkuppam,Madagadipet ,puducherry
Room 106 department of anaesthesialogy sri manakula vinayagar medical college kalitheertalkuppam,Madagadipet ,puducherry
Pondicherry
PONDICHERRY |
09080154167
devisridear@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH -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 |
Group B serratus anterior plane block |
Serratus Anterior Plane (SAP) Block – This is also performed under ultrasound guidance with a linear probe. A 23G Quincke needle is used to inject 20 ml of 0.25% Bupivacaine with 8 mg Dexamethasone in the fascial plane between the serratus anterior and latissimus dorsi muscles, overlying the 4th and 5th ribs. |
| Intervention |
Group A Modified pectoralis plane block |
Modified Pectoralis (PECS) Plane Block – This is performed under ultrasound guidance using a linear probe. A 23G Quincke needle is used to inject 20 ml of 0.25% Bupivacaine with 8 mg Dexamethasone between the pectoralis minor and serratus anterior muscles at the level of the 3rd and 4th ribs. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
Patients admitted for elective benign breast surgery
Patients of ASA physical status classification I and II
Female patients with age of 18-65 years
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Allergy to study drugs
Surgery of breast carcinoma
Emergency surgeries
Local Infection
Coagulopathy
Spine deformity
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| post extubation VAS score |
at 15 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| VAS score |
1, 2, 4, 6, 8, 12, 24 hours |
| Time to first rescue analgesia |
hours |
| total analgesic requirement |
over 24-hour period |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 2 |
|
Date of First Enrollment (India)
|
21/09/2025 |
| 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="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
|
This is a randomised controlled trial aiming to compare postoperative analgesic efficacy of two ultrasound guided modified pectoralis plane block and serratus anterior plane block in 80 female patient undergoing elective benign breast surgeries conducted at sri manakula vinayagr medical college and hosptal ,the study assesses pain relief by monitoring VAS and analgesic consumption postoperatively .Participants are randomly assigned into two equal groups Group A receiving PECS block and group B receiving SAP block both 20 ml of 0.25% bupivacaine with 8mg dexamethasone.The methodology involves strict aseptic technique and ultrasound guidance for block administration.standardized anaesthesia protocol are followed,including I gel insertion and maintained with sevoflurane ,oxygen,nitrous oxide ,postoperative pain assessed at multiple time over period of 24 hrs,with rescue analgesia administered if VAS more than 4 .Statiscal analysis using SPSS will compare pain score,time to first analgesia and total analgesic use.Ethical consideration incuded informed consent ,confidentiality,risk minimization and non monentary compensation for adverse events,with categorised as low risk and approved by IEC.This literature review support to study rationalae ,citing previous trials where both blocks improved analgesia and reduced opioid use .studies by Magoon,wang and other highlight the effectiveness of these blocks in thoracic and breast surgeries |