| CTRI Number |
CTRI/2023/05/052796 [Registered on: 17/05/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
STIL Block vs ESP Block for post-operative pain management in Carcinoma Breast Patients |
|
Scientific Title of Study
|
Ultrasound Guided STIL Block vs ESP Block for post-operative pain management in Carcinoma Breast Patients undergoing Modified Radical Mastectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
NEELESH ANAND |
| Designation |
Senior Resident |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Anaesthesiology
Sir Sunderlal Hospital
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
neelesh.anand.7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Amrita Rath |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Anaesthesiology
Sir Sunderlal Hospital
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
amritar@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Amrita Rath |
| Designation |
Assistant Professor |
| Affiliation |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Anaesthesiology
Sir Sunderlal Hospital
Institute of Medical Sciences
Banaras Hindu University
UTTAR PRADESH
221005
India |
| Phone |
|
| Fax |
|
| Email |
amritar@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
Sir Sunderlal Hospiptal Institute of Medical Sciences Banaras Hindu University |
|
|
Primary Sponsor
|
| Name |
Institute of Medical Sciences Banaras Hindu University |
| Address |
Department of Anaesthesiology
Sir Sunerlal Hospital
Institute of Medical Sciences Banaras Hindu University |
| 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 Amrita Rath |
Sir Sunderlal Hospital Banaras Hindu University |
Department of Anaesthesiology
2nd Floor
Sir Sunderlal Hospital
Institute of Medical Sciences
Banaras Hindu University
Varanasi
UTTAR PRADESH |
7379140545
amritar@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Institute of Medical Sciences BHU |
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: C501||Malignant neoplasm of central portion of breast, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector spinae Plane [ESP] block |
Patients will be given single shot of Ultrasound Guided Erector Spinae Plane [ESP] block with 20 mL of 0.25% Levobupivacaine after induction of general anaesthesia
|
| Intervention |
Subtransverse Interligamentary [STIL]Block |
Patients will be given single shot of Ultrasound Guided Subtransverse Interligamentary [STIL] block with 20 mL of 0.25% Levobupivacaine after induction of general anaesthesia
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
1. Patients of Carcinoma breast undergoing Modified Radical Mastectomy
2. Age group: 18-65 years.
3. ASA grade I and II.
4. Written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal or noncompliance
2. Allergy to local anaesthetic drugs
3. Vertebral deformity
4. Patient refusal or noncompliance
5. Severe obstructive or restrictive pulmonary diseases
6. Morbid hepatic or cardiac dysfunction
7. Unregulated DM, HTN, COPD
8. Obesity (BMI >35 kg/m2)
9. Clinical or laboratory evidence of infection
10. Coagulation disorders
11. Hemodynamically unstable patients
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
severity of pain by Numerical Rating Scale
Duration of analgesia |
2 hrs; 6 hrs; 12 hrs; 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
heart rate
blood pressure
number of rescue analgesia
total dose of fentanyl
side effects |
5 min 15 mins 30 mins 45 mins 60 mins 90 mins 120 mins 6 hr 12 hr 24
hr
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "25"
Final Enrollment numbers achieved (India)="25" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
31/05/2023 |
| Date of Study Completion (India) |
25/08/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
25/08/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="15" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
To assess the effectiveness and safety of Subtranverse
Interligamentary (STIL) block in comparison with Erector Spinae Plane (ESP)
block in patients undergoing Modified Radical Mastectomy. The
study will be conducted on 120 female patients posted for MRM. After
written informed consent patients would be equally and randomly placed into two
groups comprising of 54 each. Randomisation will be done by a computer
generated randomisation list. Group I [Control Group]- Patients will be given Ultrasound Guided
Erector Spinae Plane [ESP] block with 20 mL of 0.25% Levobupivacaine. Group II [Intervention group]- Patients will be given
Ultrasound Guided Subtransverse Interligamentary [STIL] block with 20 mL of
0.25% Levobupivacaine. The severity of
pain experienced by patients after surgery was assessed every 6 hours in the
postoperative period till 24 hours by an observer who is blinded to the study.
|