| CTRI Number |
CTRI/2022/05/042371 [Registered on: 04/05/2022] Trial Registered Prospectively |
| Last Modified On: |
01/05/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
“Effectiveness of Erector Spinae Plane(ESP) Block for postoperative pain relief in breast surgery†|
|
Scientific Title of Study
|
“A Study of safety and efficacy of IITV guided erector spinae plane(ESP) Block as novel multimodal analgesia technique for postoperative analgesia in Modified Radical Mastectomy(MRM).†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Parthkumar Vadgama |
| Designation |
Resident Doctor |
| Affiliation |
P.D.U. Govt. Medical College, Rajkot |
| Address |
403, Yogi Darshan App, Nr. CDS Bipin Rawat Underbridge Virani Chowk, Rajkot
Dept. of Anaesthesiology, P.D.U. Govt. Medical College,
Hospital Chowk, Jamnagar Road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
8485961814 |
| Fax |
|
| Email |
parthvadgama@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vrinda Oza |
| Designation |
Assistant Proffessor |
| Affiliation |
P.D.U. Govt. Medical College, Rajkot |
| Address |
Dept. of Anaesthesiology, P.D.U. Govt. Medical College,
Hospital Chowk, Jamnagar Road, Rajkot
Dept. of Anaesthesiology, P.D.U. Govt. Medical College,
Hospital Chowk, Jamnagar Road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
9228099479 |
| Fax |
|
| Email |
vrinda.agravat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parthkumar Vadgama |
| Designation |
Resident Doctor |
| Affiliation |
P.D.U. Govt. Medical College, Rajkot |
| Address |
403, Yogi Darshan App, Nr. CDS Bipin Rawat Underbridge Virani Chowk, Rajkot
Dept. of Anaesthesiology, P.D.U. Govt. Medical College,
Hospital Chowk, Jamnagar Road, Rajkot
Rajkot
GUJARAT
360002
India |
| Phone |
8485961814 |
| Fax |
|
| Email |
parthvadgama@gmail.com |
|
|
Source of Monetary or Material Support
|
| P.D.U. Govt. Medical College, Rajkot |
|
|
Primary Sponsor
|
| Name |
PDU Govt Medical College Rajkot |
| Address |
Dept. of Anaesthesiology, P.D.U. Govt. Medical College,
Hospital Chowk, Jamnagar Road, Rajkot |
| 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 Parthkumar Vadgama |
P.D.U. Govt. Medical College, Rajkot |
Dept. of Anaesthesiology, P.D.U. Govt. Medical College,
Hospital Chowk, Jamnagar Road, Rajkot
Rajkot
GUJARAT |
8485961814
parthvadgama@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTISTITUTIONAL ETHICS COMMITTEE (HUMAN) |
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, , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Erector Spinae Plane(ESP) Block |
IITV guided unilateral Erector Spinae Plane(ESP) Block is given along with IV Opioid agent as pre-medication before surgery with to the cases under study.
Total Duration of Intervention - 15 min. |
| Comparator Agent |
Intravenous Opioid Agent |
Only Loading dose of IV Opioid agent is given as pre-medication before surgery. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
a. American Society of Anaesthesiologists(ASA) Grade – I, II and III patients
b. Patients undergoing Modified Radical Mastectomy(MRM) surgery
|
|
| ExclusionCriteria |
| Details |
a. American Society of Anaesthesiologists(ASA) Grade IV and V patients
b. Patients of Age Group >65 years
c. Infection at the block site
d. Bleeding disorder or Patient is on Anti-Coagulation Therapy
e. Allergic reaction to any anaesthetic drug
f. Patients on tranquilizers, hypnotics, sedatives and other psychotropic drugs.
g. Severe Hepatic/Renal/Endocrine/Neurologic/Gastrointestinal or Cardiac dysfunction
h. Those who unable to speak or understand commands for analyzing sedation and analgesia.
i. Spine deformity
j. Patient’s refusal
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total requirement of rescue analgesia in first 24 Hrs. |
Postoperatively every 30 mins for first 2 hours, every 60 mins for next 6 hours and at 12th hour and 24th hour. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
a. Changes in Hemodynamic Parameters
b. Side Effects if any peri-operatively |
Pre-operatively. just after intubation, 5 min, 10 min, 20 min after intubation, every 30 min after intubation till 1 hr , every 1 hrly till end of surgery, Post-operatively every 1 hrly till 2 hrs, 4th hour, 8th hour, 12th hour and 24th hour post-operatively. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
05/05/2022 |
| 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="6"
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
|
Modified Radical Mastectomy(MRM)
is one of the commonly performed surgery. It is associated with moderate-to-severe
postoperative pain. Regional block for pain management has many advantages in
such patients including provision of adequate analgesia, reduced need for
opioids, decreased postoperative nausea & vomiting, postoperative pulmonary
complications, enhanced recovery, and early ambulation. The Ultrasound
(US)/IITV guided Erector Spinae Plane Block (ESPB) was initially described by
Forero for providing thoracic analgesia at the T4 transverse process (TP). ESPB
gained wide attention as it is a faster procedure that carries a lower risk of
hypotension, easy to perform, and requires less training.
Here, we compared the efficacy of unilateral
Erector Spinae Plane Block(ESP Block) with Bupivacaine (0.25%) with systemic
post-operative analgesics alone for duration, quality of post-operative
analgesia for patients undergoing modified radical mastectomy. |