| CTRI Number |
CTRI/2021/08/035542 [Registered on: 10/08/2021] Trial Registered Prospectively |
| Last Modified On: |
09/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the efficacy of ultrasound guided erector spinae block versus serratus plane block in breast cancer surgery. |
|
Scientific Title of Study
|
Ultrasound guided comparative study between erector spinae block vs serratus plane block for modified radical mastectomy-A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Saurabh Sagar |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Department Of Anaesthesiology,
Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7676230522 |
| Fax |
|
| Email |
dr.saurabhsagar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anil Kumar Paswan |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Department Of Anaesthesiology,
Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9794855871 |
| Fax |
|
| Email |
dranil1973@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Sagar |
| Designation |
Junior Resident |
| Affiliation |
Institute of Medical Sciences, Banaras Hindu University, Varanasi |
| Address |
Department Of Anaesthesiology,
Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
7676230522 |
| Fax |
|
| Email |
dr.saurabhsagar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences, Banaras Hindu University, Varanasi. |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University Varanasi |
| Address |
Department OF Anaesthesiology,
Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005 |
| 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 Saurabh Sagar |
Sir Sundarlal Hospital |
Pain OT B-block,
Room no-205,
Division-Pain and palliative care,
Department of Anaesthesiology,
Institute of Medical Sciences,
Banaras Hindu University, Varanasi-221005
Varanasi
UTTAR PRADESH |
7676230522
dr.saurabhsagar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, Institute of Medical Sciences, Banaras Hindu University |
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 For Modified Radical Mastectomy. |
Analgesic Effect of Ultrasound Guided Erector Spinae Block For Modified Radical Mastectomy. The
block will be given 20mins before skin incision. |
| Comparator Agent |
Ultrasound Guided Serratus Plane Block For Modified Radical Mastectomy. |
Analgesic Effect Of Ultrasound Guided Serratus Plane Block For Modified Radical Mastectomy. The block will be given 20mins before skin incision. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American Society Of Anesthesiologists (ASA) classification I & II status.
Patients undergoing unilateral modified radical mastectomy.
Hemodynamically stable. |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Patient having history of known allergies to any of the study drugs.
Infection at the puncture site of proposed block.
Patients with deranged coagulation and bleeding parameters (INR>1.5).
Patients with history of receiving anticoagulant treatment.
Presence of pregnancy or lactation.
Patients with cognitive or communicative impairment.
Patients having history of chronic opioid consumption.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia of the block. |
The duration of analgesia will be the time from administration of block to the first use of rescue analgesic.
Post-operative:1hour,2hours,4hours,8hours,12hours,18hours,24hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intra-operative and post-operative haemodynamic changes, intra-operative opioid & post-operative analgesic consumption, visual analogue scale (VAS) pain scores and adverse effects of the two blocks for modified radical mastectomy. |
Intra-operative:5minutes,15minutes, 30minutes,60minutes,90minutes,120minutes.
Post-operative:1hour,2Hhours,4hours, 8hours,12hours, 18hours,24hours. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
N/A |
|
Date of First Enrollment (India)
|
10/08/2021 |
| 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)
|
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
|
Breast surgery is one of the most common surgeries due to high incidence of breast cancer. Modified radical mastectomy (MRM) is one the commonly performed breast surgery. The effective pain relief is the utmost important in treating patients who are undergoing surgery. This study compares the analgesic efficacy of ultrasound guided erector spinae plane block(ESPB) and serratus anterior plane block (SAPB) in patients undergoing unilateral modified radical mastectomy (MRM). This randomized prospective study will be carried out on 40 ASA I and II patients of age group of 18-65 years of either sex undergoing unilateral modified radical mastectomy with 20 patients in each group who will be randomly allocated by sealed envelope method. After the approval by the Institutional Ethical Committee, written informed consent will be obtained from all the patient before being included in the study. They will be allocated to 2 groups by randomization.
Group ESPB - Patients will be administered ultrasound guided erector spinae block. Group SAPB - Patients will be administered ultrasound guided serratus plane block.
The duration of analgesia of the block will be observed in both the groups which will be the time from administration of block to the first use of rescue analgesic. Also, in both the groups, patients will be observed for intra-operative and post-operative hemodynamic changes, intra-operative opioid & post-operative analgesic consumption, visual analogue scale (VAS) pain scores and adverse effects of the two blocks .
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