| CTRI Number |
CTRI/2023/06/053769 [Registered on: 12/06/2023] Trial Registered Prospectively |
| Last Modified On: |
10/06/2023 |
| 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 two types of regional anaesthesia techniques i.e. erector spinae block and paravertebral block for management of pain after breast cancer surgeries |
|
Scientific Title of Study
|
Comparative study of ultrasound guided erector spinae block versus paravertebral block in post operative analgesia after breast cancer surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr JP Attri |
| Designation |
Professor |
| Affiliation |
Government medical College Amritsar |
| Address |
Room no office of vice principal GMC Amritsar Department of
Anaesthesiology and Intensive Care Government Medical College
Amritsar
Amritsar
PUNJAB
143001
India
Amritsar
PUNJAB
143001
India |
| Phone |
9501025275 |
| Fax |
|
| Email |
drjpattri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr JP Attri |
| Designation |
Professor |
| Affiliation |
Government medical College Amritsar |
| Address |
Room no office of vice principal GMC Amritsar Department of
Anaesthesiology and Intensive Care Government Medical College
Amritsar
Amritsar
PUNJAB
143001
India
Amritsar
PUNJAB
143001
India |
| Phone |
9501025275 |
| Fax |
|
| Email |
drjpattri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr JP Attri |
| Designation |
Professor |
| Affiliation |
Government medical College Amritsar |
| Address |
Room no office of vice principal GMC Amritsar Department of
Anaesthesiology and Intensive Care Government Medical College
Amritsar
Amritsar
PUNJAB
143001
India
Amritsar
PUNJAB
143001
India |
| Phone |
9501025275 |
| Fax |
|
| Email |
drjpattri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical College Amritsar |
|
|
Primary Sponsor
|
| Name |
Dr JP Attri |
| Address |
office of vice principal GMC Amritsar Department of
Anaesthesiology and Intensive Care Government Medical College
Amritsar
Amritsar
PUNJAB
143001
India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ranjana |
Department of
Anaesthesiology and Intensive Care Government Medical College
Amritsar
Amritsar
PUNJAB
143001
India |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Komalpreet Kaur |
Guru Nanak Dev Hospital Amritsar |
Department of Anaesthesia , Division- Main Surgery OT Complex, Room- Table A and Table B Government medical College Amritsar 143001
Amritsar
PUNJAB |
8699415070
kaurkharoud27@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| NSTITUTIONAL ETHICS COMMITTEE FOR BIOMEDICAL AND HEALTH RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided erector spinae block |
We will give ultrasound guided erector spinae block for post operative pain after breast cancer surgery.various parameters will be
noted and will be compared with
other groups. Total duration of intervention is from start of procedure to 24 hours post operative period. |
| Comparator Agent |
Ultrasound guided paravertebral block |
we will give ultrasound guided paravertebral block for post operative pain after breast cancer surgery. various parameters will be
noted and will be compared with
other groups. Total duration of intervention is from start of procedure to 24 hours post operative period. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
Patients aged 20 –60 years
American Society of Anesthesiologists (ASA) I or II
Patients with normal neurological status
Co-operative patients
Patients undergoing breast cancer surgeries |
|
| ExclusionCriteria |
| Details |
Refusal of patient for the procedure or to enlist in study
Patients of American Society of Anaesthesiologists (ASA) Grade III and IV
Uncooperative patients
Patients with clinically significant pulmonary pathology
Pregnant females
Patients with coagulation disorders and on anticoagulation therapy
Patient with history of allergy to local anaesthetic
Known neuropathies |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Procedural time (time required to complete the block)
2. Duration of sensory block
3. Time to first rescue analgesia
4. Total dose of rescue analgesia in 24 hours |
Baseline followed by every 30 minutes till 2 hours followed by every 2 hour till 8 hours followed by every 6 hours till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Haemodynamic changes
2. Side effects and complications
3. Patient satisfaction score
4. Surgeon satisfaction score
5. Sedation Score |
Time from start of procedure till 24 hours post surgery |
|
|
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
28/06/2023 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Breast cancer is one of the common malignancies among women. Surgical resection of the primary tumor with axillary dissection is one of the main modalities of breast cancer treatment mostly done under general anaesthesia with or without regional blocks. The present study aims to compare the efficacy of ultrasound guided paravertebral block with erector spinae block for postoperative analgesia in breast cancer surgeries in Government Medical College and Hospital, Amritsar. 60 female patients of age between 20-60 years and ASA grade I and II will be randomly divided into two groups of 30 patients, each receiving erector spinae block and paravertebral block using ultrasound guidance. The procedural time, duration of sensory block, consumption of fentanyl during 24 hours, time to rescue analgesia and total dose of rescue analgesia will be assessed in both groups. Haemodynamics will be assessed. Intraoperative and postoperative complications will also be noted. The data thus obtained will be analyzed and compared statistically. |