| CTRI Number |
CTRI/2024/03/064147 [Registered on: 14/03/2024] Trial Registered Prospectively |
| Last Modified On: |
13/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Ability of Serratus Anterior Plane block in reducing post operative pain killer requirement after breast removal surgery |
|
Scientific Title of Study
|
EFFICACY AND SAFETY OF ULTRASOUND GUIDED SERRATUS ANTERIOR PLANE BLOCK IN REDUCING POST-OPERATIVE OPIODS REQUIREMENT IN PATIENTS UNDERGOING MASTECTOMY- A RANDOMIZED CONTROL TRIAL STUDY |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pandu Ranga Rao Bangaru |
| Designation |
Post Graduate year 3 |
| Affiliation |
JLN Medical college, Ajmer, Rajasthan |
| Address |
Department of Anesthesiology, JLN Medical college, Kala Bagh, Ajmer, Rajasthan 305001
Kala Bagh, Ajmer, Rajasthan 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
07799411443 |
| Fax |
|
| Email |
dr.pandurangarao@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Veena Patodi |
| Designation |
Senior Professor |
| Affiliation |
JLN Medical college, Ajmer, Rajasthan |
| Address |
Department of Anaesthesiology, JLN Medical college, Kala Bagh, Ajmer, Rajasthan 305001
Kala Bagh, Ajmer, Rajasthan 305001
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414008276 |
| Fax |
|
| Email |
veenapatodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pandu Ranga Rao Bangaru |
| Designation |
Post Graduate year 3 |
| Affiliation |
JLN Medical college, Ajmer, Rajasthan |
| Address |
Department of Anaesthesiology, JLN Medical college, Kala Bagh, Ajmer, Rajasthan 305001
Kala Bagh, Ajmer, Rajasthan 305001
RAJASTHAN
305001
India |
| Phone |
07799411443 |
| Fax |
|
| Email |
dr.pandurangarao@gmail.com |
|
|
Source of Monetary or Material Support
|
| Departmrnt of Anaesthesiology
New OT
1 st Floor
JLN Medical college
Ajmer Rajasthan 305001 |
|
|
Primary Sponsor
|
| Name |
JLN Medical college |
| Address |
Kala Bagh,
Ajmer
Rajasthan 305001 |
| Type of Sponsor |
Government 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 Pandu Ranga Rao Bangaru |
JLN Medical college |
New OT, Department of Anaesthesiology, Kala Bagh, Ajmer, Rajasthan 305001
Ajmer
RAJASTHAN |
7799411443
dr.pandurangarao@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee JLN Medical college, Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (3) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Inj. Ropivacaine 0.2% for Serratus Anterior Plane block versus tramadol post operative rescue dosing for pain relief |
With due approval from institutional ethical committee, the study will be conducted at Jawahar Lal Nehru Medical College, Ajmer, Rajasthan on patients undergoing mastectomies under general anaesthesia. This hospital based prospective randomized controlled clinical trial study is designed to include 60 female patients. Serratus anterior Plane block will be performed in plane to the ultrasound beam with a 22G, Quincke spinal needle. A total volume of 30 ml of 0.2 % ropivacaine(60 mg) will be given only once in the plane between Serratus Anterior muscle and latissimus dorsi muscle prior to shifting to operation theatre and induction of anaesthesia. A written informed consent will be taken in prior to procedure. Participants will be followed and monitored for duration of analgesia at specified intervals till they complain of pain in post-operative period then the study will be terminated. Data will be collected and analysed using standard qualitative and quantitative tests. A p value of less than 0.05 will be considered as significant |
| Intervention |
USG guided Serratus anterior plane block |
With due approval from institutional ethical committee, the study will be conducted at Jawahar Lal Nehru Medical College, Ajmer, Rajasthan on patients undergoing mastectomies under general anaesthesia. This hospital based prospective randomized controlled clinical trial study is designed to include 60 female patients. Serratus anterior Plane block will be performed in plane to the ultrasound beam with a 22G, Quincke spinal needle. A total volume of 30 ml of 0.2 % ropivacaine(60 mg) will be given only once in the plane between Serratus Anterior muscle and latissimus dorsi muscle prior to shifting to operation theatre and induction of anaesthesia. A written informed consent will be taken in prior to procedure. Participants will be followed and monitored for duration of analgesia at specified intervals till they complain of pain in post-operative period then the study will be terminated. Data will be collected and analysed using standard qualitative and quantitative tests. A p value of less than 0.05 will be considered as significant |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA 1 AND ASA 2.
2. Age 20 - 60 years of female sex.
3. Weighing between 40 and 75 kgs.
Undergoing mastectomies under general anesthesia will be included in
the stud |
|
| ExclusionCriteria |
| Details |
1. Ineligible to provide informed consent
2. Younger than 20 years or older than 60 years of age.
3. Impaired kidney or renal functions history of alcohol or drug abuse.
4. History of chronic pain condition or daily intake of analgesics and
corticosteriods.
5. Uncontrolled systemic disease (DM, HTN)
6. Pregnant or lactating.
7. Any condition in which some drugs are contraindicated and
hypersensitivity. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia |
To assess the duration of analgesia from time of extubation to demand
of first dose of rescue analgesic.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Total postoperative analgesic consumption.
2. Haemodynamic variables like HR, SBP, DBP, MBP, SPO2 intra
operatively and post operatively.
3. Side effect if any.
|
Every 5 minutes upto 30 minutes
Baseline, 5 mins,10mins,30 mins, 45 mins, 60 mins, 90 mins, 120 mins and 150 mins |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
With due approval from institutional ethical committee, the study will be conducted at Jawahar Lal Nehru Medical College, Ajmer, Rajasthan on patients undergoing mastectomies under general anaesthesia. This hospital based prospective randomized controlled clinical trial study is designed to include 60 female patients divided into 2 groups randomly. A written informed consent will be taken in prior to procedure. Participants will be followed and monitored for duration of analgesia at specified intervals till they complain of pain in post-operative period then the study will be terminated. Data will be collected and analysed using standard qualitative and quantitative tests. A p value of less than 0.05 will be considered as significant
Patients meeting the inclusion criteria during the pre-anaesthetic evaluation will be approached for consent, once the consent has been sought patients will be randomly assigned using computer generated tables into two groups of 30 patients each. Group A and Group B Group A – In this group, patient is taken into procedure room after verifying consent & NBM status and after being positioned supine and i.v access is secured after connecting to a cardiac monitor, vitals are measured. Ultrasound guided serratus anterior plane block will be performed in the mid axillary line at the level of 5 th rib with a 10 – 12 MHz transducer probe. Under aseptic precautions skin will be infiltrated with 2-3ml of 2% lignocaine with a 26 g h1/2 inch hypodermic needle. The block will be performed in plane to the ultrasound beam with a 22G, Quincke spinal needle. A total volume of 30 ml of 0.2 % ropivacaine will be given in the plane between Serratus Anterior muscle and latissimus dorsi muscle prior to shifting to operation theatre and induction of anaesthesia. Group B : Group B will be the control group. The patients in this group will receive intravenous Tramadol for pain relief in the post operative period |