| CTRI Number |
CTRI/2023/11/059468 [Registered on: 02/11/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of the pain relieving effect of two approaches to the ultra-sound guided back muscle in patients undergoing breast operation |
|
Scientific Title of Study
|
Comparison of the analgesic efficacy two approaches to the ultra-sound guided erector spinae plane block in patients undergoing modified radical mastectomy: A randomized controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kunal Aggarwal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept of Anaesthesiology, Pain Medicine and Critical Care, Room no.14, Porta Cabin, 4th Floor, Academic Block, AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
8168973866 |
| Fax |
|
| Email |
aggarwalkunalgupta@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mritunjay Kumar |
| Designation |
Assistant Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept of Anaesthesiology, Pain Medicine and Critical Care, Room no.14, Porta Cabin, 4th Floor, Academic Block, AIIMS, Ansari Nagar
Dept of Anaesthesiology, Pain Medicine and Critical Care, Room no.14, Porta Cabin, 4th Floor, Academic Block, AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
09868023165 |
| Fax |
|
| Email |
dr.mritunjay@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kunal Aggarwal |
| Designation |
Junior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Dept of Anaesthesiology, Pain Medicine and Critical Care, Room no.14, Porta Cabin, 4th Floor, Academic Block, AIIMS, Ansari Nagar
South
DELHI
110029
India |
| Phone |
8168973866 |
| Fax |
|
| Email |
aggarwalkunalgupta@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain medicine and Critical Care, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar New Delhi 110029 |
| 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 |
| Kunal Aggarwal |
AIIMS Hospital |
Dept of Anaesthesiology, Pain Medicine and Critical Care, Operation theatre and wards, Surgical Block, AIIMS-New Delhi
South
DELHI |
8168973866
aggarwalkunagupta@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, AIIMS New Delhi |
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 |
| Comparator Agent |
Group A (BTWN) |
Patients will receive erector spinae plane block with 20 ml 0.375% ropivacaine injection administered between transverse processes prior to general anaesthesia. |
| Comparator Agent |
Group B (MED) |
Patients will receive erector spinae plane block with 20 ml 0.375% ropivacaine injection administered at medial transverse process prior to general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Female |
| Details |
a) ASA I- II
b) Scheduled to undergo elective modified radical mastectomy |
|
| ExclusionCriteria |
| Details |
a) Patient refusal for regional techniques
b) All contra-indications to regional techniques:
Local or systemic infection
Known allergy to the study drugs
Bleeding disorders
Platelet count <80,000/μL of blood
c) BMI > 35
d) Inability to use PCA device post operatively
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Efficacy of analgesic technique determined by 11-point numeric rating scale (NRS) at rest & on abduction of ipsilateral arm above the head. |
Post-operative period at 0, 0.5, 1, 2, 4, 6, 12 & 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Intraoperative opioid consumption. |
Intraoperative period |
| 24-hour fentanyl consumption |
1st 24 hours of post-operative period |
| Time to first analgesic requirement in post-operative period. |
1st 24 hours of Post operative period |
| Patient satisfaction score |
Post-operative period at 0, 0.5, 1, 2, 4, 6, 12 & 24 hours |
| ï¬ Incidence of adverse events (postoperative nausea/ vomiting, respiratory depression, pruritus, urinary retention) retention) |
1st 24 hours of post-operative period. |
|
|
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)
|
05/11/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Breast Surgery is associated with significant peri-operative pain and chronic pain. Various pain management modalities have been tried to alleviate the pain, erector spinae plane block is one of them. Recently a cadaveric study has shown two new approaches of erector spinae plane block namely "Erector Spinae Plane Block between Transverse
processes (BTWN)" and "Erector Spinae Plane Block at medial transverse process
(MED)". We wish to compare the efficacy of these two approaches of erector spinae plane block, its analgesic efficacy, its effect on perioperative opioid consumption, patient satisfaction and side effects. |