| CTRI Number |
CTRI/2022/04/042109 [Registered on: 25/04/2022] Trial Registered Prospectively |
| Last Modified On: |
28/02/2023 |
| 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 post operative analgesia between plain levobupivacaine and after adding an adjuvant dexamethasone in patient undergoing breast lumpectomies by a method called serratus anterior plane block |
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Scientific Title of Study
|
Efficacy of Levobupivacaine vs Levobupivacaine with Dexamethasone in Ultrasound guided Serratus Anterior plane block for post operative Analgesia in Breast lumpectomies: A Prospective Randomized Comparative Study.
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| Trial Acronym |
|
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karthik G S |
| Designation |
Professor |
| Affiliation |
RRMCH |
| Address |
Rajarajeswari medical college and hospital
202, Kambipura, Mysore road
Department of Anaesthesiology and critical care, 2nd floor OT complex
R R Nagar bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9538220515 |
| Fax |
|
| Email |
drgskarthik@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Karthik G S |
| Designation |
Professor |
| Affiliation |
RRMCH |
| Address |
Rajarajeswari medical college and hospital
202, Kambipura, Mysore road
Department of Anaesthesiology and critical care, 2nd floor OT complex
R R Nagar bangalore
Bangalore
KARNATAKA
560074
India |
| Phone |
9538220515 |
| Fax |
|
| Email |
drgskarthik@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Supriya R |
| Designation |
Post gradduate |
| Affiliation |
RRMCH |
| Address |
Rajarajeswari medical college and hospital
202, Kambipura, Mysore road
Department of Anaesthesiology and critical care, 2nd floor OT complex
957/B 2nd main 4th block rajajinagar bangalore 560010
Bangalore
KARNATAKA
560074
India |
| Phone |
9945825471 |
| Fax |
|
| Email |
supriya.raghunnath@gmail.com |
|
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Source of Monetary or Material Support
|
| Rajarajeswari medical college and hospital
202, Kambipura, Mysore road
Department of Anaesthesiology and critical care, 2nd floor OT complex |
|
|
Primary Sponsor
|
| Name |
Rajarajeswari medical college and hospital |
| Address |
202, Mysore road, Kambipura
560074 |
| Type of Sponsor |
Private medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Karthik GS |
Rajarajeswari medical college and hospital |
202, Mysore road, Kambipura
Department of anaesthesiology and critical care, 2nd floor OT complex
560074
Bangalore
KARNATAKA |
9538220515
drgskarthik@rediffmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| RRMCH Institutional ethics committe |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Serratus anterior plane block |
For post operative analgesia. Using ultrasound guidance serratus anterior plane block is given using either 20ml of 0.5% levobupivacaine or 20ml of 0.5% levobupivacaine with 8mg of dexamethasone in the serratus anterior plane region.
Block is given only once and then patient followed up |
| Comparator Agent |
Serratus anterior plane block for post operative analgesia |
Levobupivacaine Vs levobupivacaine with dexamethasone |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Age 18 to 45 years belonging to ASA I and II onlu |
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| ExclusionCriteria |
| Details |
Patients with hypersensitivity to local anesthetic used
Patients with bleeding disorders, uncontrolled diabetes mellitus, renal and liver disorders, epilepsy, pregnancy
Patient refusal |
|
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Method of Generating Random Sequence
|
Other |
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Method of Concealment
|
Other |
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Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Duration of postoperative analgesia with Serratus Anterior Block in both groups |
Pain intensity of the patient will be measured at 1,6,12,18 and 24 hours post surgery using VAS scoring. |
|
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Secondary Outcome
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| Outcome |
TimePoints |
Duration of Sensory Blockade
Total Rescue Analgesia requirement in 24hours
Changes in hemodynamic parameters post-operatively
- SPO2
- Heart rate
- Blood pressure
Post-operative Complications if any.
|
1, 6, 12, 18 and 24 hrs post surgery |
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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" |
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Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/04/2022 |
| 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="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
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Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
|
uAfter
obtaining the institute’s Ethical committee approval a comparative study will be carried out in Rajarajeswari
Medical college and Hospital, Bangalore.
uInformed
written consent will be taken from the patients.
uPatients
will be divided into 2 groups of 25
patients each by single blinded sealed envelope code technique.
uGroup
L - Will receive 20ml of 0.5%
Levobupivacaine plus 2ml of normal saline.
uGroup
LD - Will receive 20ml of 0.5% Levobupivacaine with 8mg of Dexamethasone
(2ml).
uPain
intensity of the patient will be measured at 1,6,12,18 and 24 hours post surgery
using VAS scoring. The patient will be given rescue analgesic in the form of
Injection Paracetamol 1g IV if the VAS score is more than 4/10.
|