| CTRI Number |
CTRI/2025/03/083496 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
25/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Other (Specify) [ERECTOR SPINAE PLANE BLOCK] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
An ultrasound-guided back injection reduces pain after breast cancer surgery. |
|
Scientific Title of Study
|
Effect of ultrasound guided erector spinae plane block for post operative analgesia in patients undergoing modified radical stectomy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr SUSHMITA KARARI |
| Designation |
Junior Resident in Department of Anaestheology |
| Affiliation |
Gandhi Medical College |
| Address |
Operation theatre, 2nd floor, Department of Anesthesiology, Hamidia
hospital, Gandhi medical college, Bhopal
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8602831855 |
| Fax |
|
| Email |
sushkarari@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandana Pandey |
| Designation |
Assistant Professor in Department of Anesthesiology |
| Affiliation |
Hamidia Hospital, Gandhi Medical College |
| Address |
Operation theatre, 2nd floor, Department of Anesthesiology, Hamidia
hospital, Gandhi medical college, Bhopal MADHYA
PRADESH
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7898169898 |
| Fax |
|
| Email |
pandeyvandana92@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vandana Pandey |
| Designation |
Assistant Professor in Department of Anesthesiology |
| Affiliation |
Hamidia Hospital, Gandhi Medical College |
| Address |
Operation theatre, 2nd floor, Department of Anesthesiology, Hamidia
hospital, Gandhi medical college, Bhopal MADHYA
PRADESH
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
7898169898 |
| Fax |
|
| Email |
pandeyvandana92@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Gandhi medical College, Bhopal, Madhya Pradesh, India,
462001 |
|
|
Primary Sponsor
|
| Name |
Gandhi Medical College |
| Address |
Gandhi medical college, Bhopal, Madhya Pradesh, 462001 |
| 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 Sushmita Karari |
Gandhi Medical College |
Room no 2, Department
of Anaesthesiology,
Block 1, Hamidia
Hospital, Gandhi
medical college,
Bhopal
MADHYA PRADESH |
8602831855
sushkarari@gmail.com |
|
|
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: O||Medical and Surgical, (2) ICD-10 Condition: C504||Malignant neoplasm of upper-outerquadrant of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bupivacaine,
Fentanyl,
ULTRASOUND GUIDED ERECTOR SPINAE PLANE BLOCK |
Study is to evaluate analgesic efficacy of ultrasound guided erector spinae plane block with 0.25% (30ml) of bupivacaine post operative analgesia in patients undergoing modified radical mastectomy under general anesthesia. |
| Comparator Agent |
Diclofenac, Tramadol, Vas score and Post operative nausea and vomiting |
No block for female of 25 to 65 age group with no carcinoma undergoing modified radical mastectomy. |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1.Female patients aged 25-65 years old
2.ASA class I or II scheduled for elective unilateral MRM
3.Patients giving consent and willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
1.Local infection at the injection site
2.Morbid Obesity (BMI less 35 Height/meter square).
3.Patients with history of bleeding diathesis
4.Persistent narcotics abusers
5.Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the effect of ESP( Erector Spinae plane Block) on post operative analgesia in patients undergoing Mordified radical mastectomy surgeries under general anaesthesia |
Post operative 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To evaluate the following
1.Time to first rescue analgesic
2.Total 24 hours opioid consumption
3.Post operative nausea and vomiting |
Post operative 24 hours |
|
|
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)
|
12/04/2025 |
| 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="4"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
Ultrasound guided erector spinae plane block (ESPB) is a novel
regional Anesthesia technique in which local anesthetic (LA) injection is
performed into the fascial plane situated between the transverse process of the
vertebra and the erector spinae muscle.
It is a technically simple procedure, with easily identified sonographic
landmarks, for analgesia in patients undergoing thoracic, abdominal, lumbar,
and urologic surgery. The ESPB can provide extensive ranges of
ventral and dorsal ramus blockade from T1-2 to T8-12 and allows easy insertion
of a catheter into the distension induced by the injection. Moreover, the ESPB is performed away from the pleura and neuraxis, reducing the
risks of complications associated with these structures. All patients will undergo
through pain assessment before surgery. They will be also explained about VAS
in the pre op visit using a 10 point scale.
|