| CTRI Number |
CTRI/2021/09/036957 [Registered on: 29/09/2021] Trial Registered Prospectively |
| Last Modified On: |
28/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
A Comparitive study of two different ultrasound guided block for breast Surgeries. |
|
Scientific Title of Study
|
A Comparitive study of efficacy of ultrasound guided Pectoralis block vs Serrartus anterior plane block for post operative analgesia after unilateral breast 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 Pratap shetty |
| Designation |
Junior resident |
| Affiliation |
Vijayanagar Institute of Medical Sciences, Ballari |
| Address |
Department of Anaesthesiology Vijayanagar Institute of MedicalSciences, Cantonment, Bellary
Bellary
KARNATAKA
583104
India |
| Phone |
6361178570 |
| Fax |
|
| Email |
prathap.prithvi2013@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pratap shetty |
| Designation |
Junior resident |
| Affiliation |
Vijayanagar Institute of Medical Sciences, Ballari |
| Address |
Department of Anaesthesiology Vijayanagar Institute of MedicalSciences, Cantonment, Bellary
Bellary
KARNATAKA
583104
India |
| Phone |
6361178570 |
| Fax |
|
| Email |
prathap.prithvi2013@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Srinivasalu D |
| Designation |
Professor |
| Affiliation |
Vijayanagar Institute of Medical Sciences, Ballari |
| Address |
Department of Anaesthesiology Vijayanagar Institute of MedicalSciences, Cantonment, Bellary
Bellary
KARNATAKA
583104
India |
| Phone |
9845224880 |
| Fax |
|
| Email |
drsrinivasd@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Vijayanagar Institute of Medical Sciences |
| Address |
Cantonment, Ballari, 583104 |
| 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 |
| Pratap shetty |
Vijayanagara Institute of medical sciences |
contontment, Bellary 583104
Bellary
KARNATAKA |
6361178570
prathap.prithvi2013@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vijayanagar Institute ofMedical Sciences Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: C579||Malignant neoplasm of female genital organ, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ultrasound guided pecs I and pecs II for post operative analgesia |
Patients undergoing unilateral breast surgeries are given
usg guided Pectoralis block (I and II) with 0.5% ropivacaine 30ml for evaluation of duration of post operative analgesia. |
| Intervention |
Ultrasound guided serratus anterior plane block for post Operative analgesia |
Patients undergoing unilateral breast surgeries are given usg guided Serratus anterior plane block with 0.5% ropivacaine 30mlfor evaluation of duration of post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients of 18-80 of age of either sex,posted for elective/emergency breast surgeries under general anaesthesia.
2) American Society of Anesthesiologists physical status I to II |
|
| ExclusionCriteria |
| Details |
1) Refusal by patients for the procedure
2) Patients with deranged coagulation profile or having bleeding diathesis.
3) History of local infection or chest wall deformities.
4) patients with allergy to local anesthetic agents.
5) patients with history of significant systemic disorders |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of post operative analgesia |
Duration of post operative analgesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) the procedure time
2) Area under curve of numerical rating scale pain intensity scores at rest over time.
3) Area under curve of NRS scores on movement over time, active sensory block duration, tramadol consumption, and elapsed time between completion of surgery and first administration of rescue analgesia.
4) Estimation of peak expiratory flow using peak flow meter till need for rescue analgesia. |
Extubation to first resue analgesia |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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 4 |
|
Date of First Enrollment (India)
|
10/10/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/10/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
An Increasing number of women survive breast cancer, which is most
common Cancer in women, Breast cancer surgery is associated with severe post operative pain in nearly 40% of women undergoing this surgical procedure.
Capitalizing on modern portable high resolution ultrasound(US) guidance,
pectoralis(PEC) and serratus anterior fascial plane blocks have been recently been described for analgesia after breast surgery...
However evidence of analgesic efficacy of these fascial plane blocks
remains limited to a single randomised controlled trial that was neither double blinded not placebo-controlled and didnot compare these blocks with each other
|