| CTRI Number |
CTRI/2024/08/072684 [Registered on: 19/08/2024] Trial Registered Prospectively |
| Last Modified On: |
13/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare intraoperative pectoral nerve block vs serratus anterior plane block undergoing modified radical mastectomy for breast cancer |
|
Scientific Title of Study
|
Effectiveness of Post Operative Analgesia with Intraoperative Pectoral Nerve block versus Serratus Anterior Block in patients undergoing Modified Radical Mastectomy (MRM) for breast cancer -A Randomized Control 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 |
DR YARRAMSETTY HEMASINDHUJA |
| Designation |
PostGraduate Resident |
| Affiliation |
IMS SUM HOSPITAL |
| Address |
Department of Anaesthesiology, , kalinganagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8929310422 |
| Fax |
|
| Email |
y.h.sindhuja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SWARNA BANERJEE |
| Designation |
PROFESSOR |
| Affiliation |
IMS SUM HOSPITAL |
| Address |
Department of Anaesthesiology, Kalinganagar ,BHUBANESWAR
Khordha
ORISSA
751003
India |
| Phone |
9437341397 |
| Fax |
|
| Email |
swarnabanerjee@soa.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR YARRAMSETTY HEMA SINDHUJA |
| Designation |
PostGraduate Resident |
| Affiliation |
IMS SUM HOSPITAL |
| Address |
Department of Anaesthesiology, Kalinganagar, Bhubaneswar
Khordha
ORISSA
751003
India |
| Phone |
8929310422 |
| Fax |
|
| Email |
y.h.sindhuja@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Institute of Medical sciences and sum hospital |
| Address |
Kalinganagar, Bhubaneswar,Orissa 751003 |
| Type of Sponsor |
Private medical college |
|
|
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 Yarramsetty Hema Sindhuja |
IMS SUM HOSPITAL |
Department of Anesthesiology, Kalinganagar,Bhubaneswar
Khordha
ORISSA |
8929310422
y.h.sindhuja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Institute of Medical Sciences(IMS) sum hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group 1 INTRAOPERATIVE PECTORAL NERVE BLOCK |
Intraoperative Pectoral block group, after the wash of the wound and insertion of the drain, PECS (II) block was performed after identifying the Medial and Lateral Pectoral Nerves. First 10 ml injection of a solution containing 0.2% Ropivacaine and 8 mg Dexamethasone was given making a bulge around the above two nerves. In the second injection, 20 ml of drug solution was given at a parallel course of the long Thoracic Nerve in between the Pectoral Minor and Serratus Anterior planes |
| Comparator Agent |
Group 2
SERRATUS ANTERIOR PLANE BLOCK |
An Ultrasound guided Serratus block was done with the patient in the lateral position,. The Ribs, Pleura and overlying Serratus muscle were identified and the needle was advanced cephalad in plane until the tip touched the 4th rib.We injected (30ml Ropivacaine 0.5% +8 mg Dexamethasone between Serratus Anterior and Latissimus Dorsi muscles for the Serratus plane block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1.Patients aged 18-60years
2. Patients scheduled for Elective Modified Radical Mastectomy
3.Patients who gave Informed and Written consent |
|
| ExclusionCriteria |
| Details |
1.Patients who are not willing to give consent for the study.
2.Patients with any history of allergy to Local Anesthetic drugs.
3.patients with a history of bleeding diathesis.
4.Patients on anticoagulant medication, with body mass index more than 35 kg/m2 and patients being treated for chronic pain disorders were excluded from the study.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First dose of rescue Analgesia TRAMADOL requirement |
first 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Total dose of analgesic requirement in first 24 hrs in both the groups
2.VAS score at rest & during shoulder movement postoperatively.
3.Side effects PONV & Other Complications
|
0hr,2hours,4hours,8hours,12 hours,24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
26/08/2024 |
| 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
|
This study is a Randomized ,Double blind, Parallel group, Comparing Effectiveness of Post Operative Analgesia with Intraoperative Pectoral Nerve block versus Serratus Anterior Block in patients undergoing Modified Radical Mastectomy (MRM) for breast cancer that will be conducted in IMS&SUM Hospital Bhubaneswar .The Primary Outcome is First dose of rescue Analgesia TRAMADOL using VAS Score in both the groups. The Secondary Outcome is total dose of analgesic requirement in first 24 hours in both the groups ,VAS score at rest and during shoulder movement at 0 hour 2hours,4hours,8hours,12hours and24hours postoperatively and Side effects PONV and Other Complications. |