| CTRI Number |
CTRI/2024/02/062869 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
19/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study of comparison of posterior thoracic Plane Block in patients undergoing modified radical mastectomy for pain relief |
|
Scientific Title of Study
|
Comparison of analgesic efficacy of Erector Spinae Plane Block with combined Rhomboid Intercostal and Subserratus Plane Block in patients undergoing modified radical mastectomy: a randomized control trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Poonam Kumari |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room-1,5th floor Ot complex,IPD block,AIIMS Patna Department of anaesthesiology,5th floor Ot complex,IPD block,AIIMS Patna Patna BIHAR 801507 India |
| Phone |
7992418189 |
| Fax |
|
| Email |
drpoonam1981@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Athira Ramesh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room-11,5th floor Ot complex,IPD block,AIIMS Patna Department of Anaesthesiology,5th floor Ot complex,IPD block,AIIMS Patna Patna BIHAR 801507 India |
| Phone |
9840604302 |
| Fax |
|
| Email |
athiraramesh18@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Athira Ramesh |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences,Patna |
| Address |
Room-11,5th floor Ot complex,IPD block,AIIMS Patna Department of Anaesthesiolgy,5th floor Ot complex,IPD block,AIIMS Patna Patna BIHAR 801507 India |
| Phone |
9840604302 |
| Fax |
|
| Email |
athiraramesh18@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences,Patna |
| Address |
Department of Anesthesiology, IPD building,OT complex. |
| 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 Poonam Kumari |
All India Institute of Medical Sciences,Patna |
Department of Anaethsiology,OT complex,IPD building,AIIMS Campus,Patna Patna BIHAR |
7992418189
drpoonam1981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC AIIMS Patna |
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: C509||Malignant neoplasm of breast of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
US-guided Erector spinae Plane block using 20ml of 0.25%. Bupivacaine along with GA |
Group I Will receive US-guided Erector spinae Plane block using 20ml of 0.25%. Bupivacaine along with GA |
| Comparator Agent |
US-guided rhomboid intercostal block combined with the sub-serratus plane block (RISS) using 20ml+20ml of 0.25% Bupivacaine along with GA |
Group II will receive US-guided rhomboid intercostal block combined with the sub-serratus plane block (RISS) using 20ml+20ml of 0.25% Bupivacaine along with GA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients willing to give written informed consent 2. Aged 18-65 years
3. ASA I –II patients scheduled to undergo elective MRM surgery under GA
|
|
| ExclusionCriteria |
|
|
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 |
| To compare the requirement of postoperative opioid consumption |
To compare the requirement of postoperative opioid consumption |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Intraoperative opioid consumption
2.To determine time of first rescue analgesic administration
3.To measure average pain NRS score at 24 hour postoperatively period
4.Satisfaction score assessment
5. To evaluate any adverse effect
|
To measure average pain NRS score at 24 hour postoperatively period (30 minutes, 2 hour, 4 hour, 8 hour, 12 hour, 24 hour)
|
|
|
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
01/03/2024 |
| 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
|
N/A |
|
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 the most common surgery for breast cancer that is
associated with marked postoperative pain.
Ultrasound
guided fascial plane blocks have been rapidly incorporated into regional
anesthesia practice. Fascial
plane blocks are emerging to provide feasible, safe alternatives comparing to epidural
analgesia for management of pain. The ultrasound guided rhomboid
intercostal block combined with the subserratus plane block (RISS) is a novel
analgesic technique recently described by Elsharkawy et al. There are only few
case reports, RCT’s and observational studies carried out to study the efficacy
of this block. We propose to conduct this
randomized clinical trial to compare the analgesic efficacy of Erector spinae plane block with
combined Rhomboid intercostal and sub serratus plane block in patient
undergoing modified radical mastectomy.
Problem statement- MRM surgery involves extensive dissection results in severe pain and can lead to significant halted postoperative recovery if pain isn’t managed appropriately. Opioids are considered to be the mainstay for perioperative
pain management, however its usage is associated with adverse effects like
respiratory depression, postoperative nausea vomiting. Current practice includes performance of fascial plane blocks including
PEC block, Paravertebral block, Erector spinae plane block.
Rationale –
Peripheral nerve blocks are known to be effective for pain management
during and after surgeries. The ultrasound guided
Rhomboid Intercostal block combined with the Subserratus plane block (RISS) and Erector Spinae plane block (ESP) are safe and effective technique
for multimodal pain management during perioperative period. Regional
anaesthesia techniques, including ESP and RISS, provide targeted and prolonged analgesia while
minimizing systemic opioid consumption. These techniques offer the advantage of
reduced opioid-related side effects.Both techniques are the newer for postoperative pain management.
Novelty- There
are only few case reports, RCT’s and observational studies carried out to study
the efficacy of this block. There
is no RCT
Comparing the analgesic efficacy of Erector
Spinae Plane Block with combined Rhomboid Intercostal and Subserratus Plane
Block in patients undergoing modified radical mastectomy.
Expected outcome and application –Analyze the analgesic efficacy of Erector Spinae
Plane Block with combined Rhomboid Intercostal and Subserratus Plane Block in
patients undergoing modified radical mastectomy. Reduced opioid consumption and better
pain scores in adult patients undergoing modified radical mastectomy. This will
facilitate to include this block as a part of multimodal analgesic regimen in
routine practice in our set up in this subset of patients.
Research question(s) - Is
ultrasound guided Rhomboid Intercostal combined with Subserratus plane Block
(RISS) better analgesic technique than Erector Spinae Plane block with less
adverse effects in patients undergoing modified radical mastectomy (MRM)?
Research hypothesis (es): We
hypothesize that the analgesic efficacy of Rhomboid Intercostal combined with
Subserratus plane Block (RISS) would be better than Erector Spinae Plane (ESP)
for patients undergoing MRM surgery. |