| CTRI Number |
CTRI/2022/11/047556 [Registered on: 23/11/2022] Trial Registered Prospectively |
| Last Modified On: |
21/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the efficacy of plain ropivacaine with ropivacaine with dexamethasone using ultrasound guidance for serratus anterior plane block in breast surgeries for post operative pain relief |
|
Scientific Title of Study
|
Efficacy of Plain Ropivacaine versus Ropivacaine with Dexamethasone in Ultrasound guided Serratus Anterior plane block for Post Operative Analgesia in Breast lumpectomies: A Prospective, Randomised Comparative 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, Mysore Road, Kambipura, 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 |
| Dr Rahul S |
Rajarajeswari Medical College and Hospital |
Department of Anaesthesiology
Rajarajeswari Medical College and Hospital
202, Mysore Rd, Kengeri Satellite Town, Kambipura, Karnataka 560074
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, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Serratus Anterior Plane Block |
Ultrasound guided Serratus Anterior Plane Block With Inj.Ropivacaine 0.5% 25ml with 2ml normal saline. Patient will be
followed up for 24 hours. VAS score will be recorded every 6 hours and rescue
analgesia will be given if VAS
score is more than 4 |
| Comparator Agent |
Serratus anterior plane block with Ropivacaine and Dexamethasone |
Ultrasound guided Serratus anterior plane block with Inj.Ropivacaine 0.5% 25ml with Inj.Dexamethsone 8mg (2ml). Patient will be followed up for 24 hours. VAS score will be recorded every 6 hours and rescue
analgesia will be given if VAS
score is more than 4 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Female |
| Details |
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 |
| Estimation of Duration of analgesia with Serratus Anterior Block |
VAS score at 0,1,6,12,18,12 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Duration of Sensory Blockade
2)Total Rescue Analgesia requirement
3)Changes in hemodynamic parameters post-operatively
SPO2
Blood pressure
Heart rate
5)Post operative Complications if any |
score taken at 0,1,6,12,18,24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
29/11/2022 |
| 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
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Serratus Anterior Plane Block has been extensively used for Post Operative pain management for Breast surgeries. Ropivacaine is used widely in regional anesthesia as one of long-acting local anaesthetics, because of its relatively larger maximum dosage and relatively lower systemic toxicity and neurotoxicity, compared with bupivacaine. Adjuvants to local anaesthetics like Dexamethasone increases the duration of action for post operative analgesia. In the past decade, there has been an increased interest in the use of regional nerve blocks for post-thoracoscopy and post-thoracotomy analgesia. This is especially related to the introduction of ultrasound guidance, which has facilitated the administration of a variety of plane blocks to achieve effective regional anesthesia. In our study an effort has been made to compare duration post operative analgesia between Ropivacaine versus Ropivacaine with Dexamethasone in patients undergoing Breast lumpectomies. |