| CTRI Number |
CTRI/2021/12/038627 [Registered on: 15/12/2021] Trial Registered Prospectively |
| Last Modified On: |
25/12/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of efficacy of two different techniques of Ultrasound guided local anesthetic drug
injections for postoperative pain relief in radical breast surgeries. |
|
Scientific Title of Study
|
Comparison Of Efficacy Of Ultrasound Guided Single Level Thoracic Paravertebral Block Versus
Complete Antethoracic Block For Postoperative Analgesia In Modified Radical Mastectomy:A Non Inferiority
Randomized Controlled Trial |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchi Singh |
| Designation |
Senior Resident |
| Affiliation |
Dr B.R.A.I.R.C.H.,All India Institute of Medical Sciences,New Delhi |
| Address |
Department of Oncoanesthesia and Palliative medicine, Dr BRA IRCH
Department of Oncoanesthesia and Palliative medicine, Dr BRA IRCH
New Delhi
DELHI
110023
India |
| Phone |
09165291956 |
| Fax |
- |
| Email |
instantruchi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ruchi Singh |
| Designation |
Senior Resident |
| Affiliation |
Dr B.R.A.I.R.C.H.,All India Institute of Medical Sciences,New Delhi |
| Address |
Department of Oncoanesthesia and Palliative medicine, Dr BRA IRCH
Department of Oncoanesthesia and Palliative medicine, Dr BRA IRCH
New Delhi
DELHI
110023
India |
| Phone |
09165291956 |
| Fax |
- |
| Email |
instantruchi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sachidanand Jee Bharti |
| Designation |
Additional Professor |
| Affiliation |
Dr B.R.A.I.R.C.H.,All India Institute of Medical Sciences,New Delhi |
| Address |
Room No.139, Department of Oncoanesthesia and Palliative
Medicine,Dr. B.R.A. I.R.C.H., A.I.I.M.S., New Delhi
Room No.139, Department of Oncoanesthesia and Palliative
Medicine,Dr. B.R.A. I.R.C.H., A.I.I.M.S., New Delhi
New Delhi
DELHI
110023
India |
| Phone |
9968436042 |
| Fax |
- |
| Email |
sachidadr@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| AIIMS, Oncology Department |
|
|
Primary Sponsor
|
| Name |
AIIMS |
| Address |
Department of Onco-Anaesthesia and Palliative Medicine, All India Institute of Medical Sciences,
Ansari Nagar, New Delhi |
| 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 Sachidanand Jee Bharti |
AIIMS |
Oncology, Operation Theatre
Dr BRAIRCH, All India Institute of Medical sciences,New Delhi
New Delhi
DELHI |
9968436042
-
sachidadr@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C50||Malignant neoplasm of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Complete Antethoracic Block |
Patients will receive Complete
Antethoracic block with 60ml
0.2% ropivacaine along with
general anaesthesia. |
| Comparator Agent |
Thoracic Paravertebral block |
Patients will receive single level
thoracic Paravertebral block
with 25ml 0.5% ropivacaine
along with general anaesthesia.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
1. ASA I and II
2. Patients posted for MRM
3. Patients giving written informed consent to participate in the study
|
|
| ExclusionCriteria |
| Details |
1. BMI > 35kg/m2
2. Patient with infection at the site of injection
3. Coagulopathy
4. Spine deformity
5. Drug addicts or history of opioid dependence
6. Patients with history of allergy to opioids or local anaesthetics |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To measure the duration of Post-operative
analgesia (that is, time to first rescue analgesia
after administration of block ).
|
Post-operative (0
min) ,30 min ,1, 2 , 6 ,12 and 24 hours or as per patients request within 24hours in postoperative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total rescue analgesic requirement in
Post-operative period.
|
Post-operative (0
min) ,30 min ,1, 2 , 6 ,12 and 24 hours or as per patients request within 24hours of surgery |
| Comparison of Post-operative pain ( using numeric rating scale) and adverse effects |
Post-operative (0
min) ,30 min ,1, 2 , 6 ,12 and 24 hours |
To evaluate and compare patient satisfaction with the block
procedure and at the end of 24hours in postoperative period. |
Immediately after the block and at the end of 24hours in postoperative period. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
Date of First Enrollment (India)
Modification(s)
|
16/12/2021 |
| Date of Study Completion (India) |
15/03/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Breast cancer is increasingly becoming the most common cancer among females worldwide.Modified radical mastectomy(MRM) is a common surgical procedure being performed for patients with breast cancer.Perioperative pain management is one of the crucial elements required for optimal outcome of patients undergoing oncosurgical procedures.The optimal use of analgesic technique provides both short term benefits like adequate pain management,reduced postoperative nausea and vomiting,improved quality of surgical recovery and long term benefits like reduced risk of development of chronic postsurgical pain and development of metastases and recurrent disease.A number of regional anesthetic techniques like local wound infiltration,thoracic epidural anesthesia and thoracic paravertebral block and more recently fascial blocks have been employed for perioperative pain in patients undergoing breast cancer surgeries.The fascial blocks include classical and modified Pectoralis nerve block(PECS),Serratus anterior plane(SAP) and Erector spinae plane block(ESPB).The pectoral nerve block is an easy and safe nerve block for breast surgery.But it does not sufficiently block the anterior branches of the intercostal nerves (from T2 to T6) or the lateral branches of the intercostal nerves (from T5 to T6); therefore, postoperative analgesia of the internal and inferior mammary area may be insufficient. Complete Antethoracic block blocks these spared anterior and lateral branches of intercostal nerves too,hence better analgesia of the breast is provided.There is a case report on analgesic effect of complete antethoracic block,but it has not been compared with paravertebral block to compare its analgesic efficacy previously.Hence,with the above background, we planned a prospective randomized clinical trial to compare the analgesic efficacy of single level thoracic paravertebral block and complete antethoracic block in patients undergoing modified radical mastectomy. |