| CTRI Number |
CTRI/2022/11/047510 [Registered on: 22/11/2022] Trial Registered Prospectively |
| Last Modified On: |
11/04/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of ultrasound guided Nerve blocks for post operative pain relief in breast surgeries |
|
Scientific Title of Study
|
Efficacy Of Ropivacaine In Ultrsound Guided Pectoralis Nerve Block 2 Versus Serratus Anterior Plane block For Post Operative Analgesia In Breast Surgeries : A Prospective, Comparitive Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rahul S |
| Designation |
Postgraduate |
| Affiliation |
Rajarajeswari Medical college and Hospital |
| Address |
Department of Anaesthesiology
Rajarajeswari Medical college and Hospital, Mysore Road, Kambipura, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9945662439 |
| Fax |
|
| Email |
rahulsrinivasan2507@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthik G S |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Medical college and Hospital |
| Address |
Department of Anaesthesiology
Rajarajeswari Medical college and Hospital, Mysore Road, Kambipura, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9538220515 |
| Fax |
|
| Email |
drgskarthik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Karthik G S |
| Designation |
Professor |
| Affiliation |
Rajarajeswari Medical college and Hospital |
| Address |
Department of Anaesthesiology
Rajarajeswari Medical college and Hospital, Mysore Road, Kambipura, Bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9538220515 |
| Fax |
|
| Email |
drgskarthik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajarajeswari Medical college and Hospital
Hospital, Bangalore, Karnataka - 560074 |
|
|
Primary Sponsor
|
| Name |
Dr Rahul S |
| Address |
202, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka 560074 |
| 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 |
| DrRahul S |
Rajarajeswari Medical college and hospital |
Department of Anaesthesiology
Rajarajeswari Medical college and hospital
202, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka
Bangalore
KARNATAKA |
9945662439
rahulsrinivasan2507@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Rajarajeswari Medical College and Hospital - Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: D249||Benign neoplasm of unspecified breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Pectoralis Nerve Block 2 |
Ultrasound guided Pectoralis Nerve Block 2 given with Inj.Ropivacaine 0.5% 25ml before the start of surgery |
| Comparator Agent |
Serratus Anterior Plane Block |
Ultrasound guided Serratus Anterior Plane Block given with Inj.Ropivacaine 0.5% 25ml before the start of surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Patients between 18-45 years undergoing breast surgery
ASA grade 1 and 2 patient |
|
| ExclusionCriteria |
| Details |
Patient with known hypersensitivity to local anaesthetic
Patient with bleeding disorder, uncontrolled Diabetes Mellitus, Renal & Liver Diseases
Pregnant women
Patient with Epilepsy
Mentally unstable patients
Patient refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare Sensory blockade and the requirement of rescue analgesia |
To note VAS score at 0,1,6,12,18,24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative hemodynamics |
At 0,1,6,12,18,24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
29/11/2022 |
| Date of Study Completion (India) |
07/04/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pectoralis Nerve block 2 and Serratus anterior nerve block has been used to provide post operative analgesia for thoracic surgeries. Nerve blocks help to provide post operative pain relief and also reduce consumption of NSAIDs leading to early ambulation and reduced complications. In our study we compare between the two Nerve blocks in Breast surgeries for duration of sensory blockade and total consumption of rescue analgesic |