| CTRI Number |
CTRI/2022/11/047037 [Registered on: 04/11/2022] Trial Registered Prospectively |
| Last Modified On: |
31/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief with blockade of nerves between serratus muscles or rhomboid intercostal muscles in patients undergoing breast cancer surgery |
|
Scientific Title of Study
|
Comparison between ultrasound guided serratus anterior plane block and rhomboid intercostal plane block for postoperative analgesia in patients undergoing modified radical mastectomy- A randomized controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yuireishang Eshidang |
| Designation |
PG student |
| Affiliation |
Department of Anaesthesia, Lady Hardinge Medical College |
| Address |
Department of Anaesthesiology Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi
Central DELHI 110001 India |
| Phone |
8414024722 |
| Fax |
|
| Email |
eshidangyuri@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Maitree Pandey |
| Designation |
Director Professor |
| Affiliation |
Department of Anaesthesia, Lady hardinge Medical College |
| Address |
Department of Anaesthesiology Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi
Central DELHI 110001 India |
| Phone |
9810570515 |
| Fax |
|
| Email |
Maitreepandey@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Nishant Kumar |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia, Lady Hardinge Medical College |
| Address |
Department of Anaesthesiology Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi
Central DELHI 110001 India |
| Phone |
9811934659 |
| Fax |
|
| Email |
kumarnishant@yahoo.co.uk |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical College, Shaheed Bhagat Singh Marg, New-Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical College |
| Address |
Department of Anaesthesiology Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi |
| 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 |
| Yuireishang Eshidang |
Lady Hardinge Medical College |
Main Operation Theatre, Department of Anaesthesiology Lady Hardinge Medical College Shahid Bhagat Singh Marg New Delhi Central DELHI |
8414024722
eshidangyuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee for Human Research LHMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Rhomboid intercostal plane block |
Pre-operative USG guided rhomboid intercostal plane block will be administered before the surgery begin. |
| Comparator Agent |
Serratus anterior plane block |
Pre-operative USG guided serratus anterior plane block will be administered before the surgery begin. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Age more than 18 years of either sex planned for modified radical mastectomy |
|
| ExclusionCriteria |
| Details |
Any known drug allergies and contraindication to nerve block like coagulopathy, bleeding diathesis and local site infection |
|
|
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 |
| Comparison of mean opioid consumption (in morphine equivalent mg/kg) at first 24 hours postoperatively in both the groups |
24 hours postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Median NRS at 0, 3,6,12 and 24 hours postoperatively
Mean duration of analgesia (in minutes)
Total number of skin puncture to perform the block
Mean duration taken (in minutes) for completion of block
Proportion of patients developing complications related to block like hematoma, pleural puncture and winging of scapula |
24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
07/11/2022 |
| Date of Study Completion (India) |
26/01/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="4" Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none as yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Surgery on the chest wall is relatively common and can be associated with considerable postoperative discomfort and pain. Breast cancer is a common cancer affecting women, accounting for 31% of all new cancer cases1,2. Modified radical mastectomy (MRM), commonly performed in patients of breast cancer, causes significant acute pain in 8-25% of patients and if not treated adequately may progress to chronic pain states in 25–60% of cases3. Regional blocks for breast surgery reduce post-operative pain, opioid requirement, nausea and vomiting and duration of stay in post anesthesia care unit4. Various regional anesthesia techniques with varying efficacy have been described for management of post-operative pain following breast surgery. These include thoracic epidural or paravertebral block, intercostal nerve block, pectoral nerve blocks and the newer USG guided fascial plane blocks like serratus anterior plane block (SAP) and rhomboid intercostal plane block (RIPB)5. Serratus anterior plane block (SAP) was first proposed by Blanco et al in 2013, and provides good postoperative analgesia after MRM. It blocks T2-T9 intercostal nerves and provides analgesia over the chest wall and axillary region6. It has shown to reduce postoperative opioid consumption7. Rhomboid intercostal plane block (RIPB) is a new fascial block technique described by Elsharkawy et al8 in 2016. RIPB is easier and can be performed reliably with the point of entry away from the involved/ surgical area. The block provides analgesia for the anterior and posterior thorax and has been studied extensively for thoracic surgeries. However, it has not been studied much for MRM, but the few available studies have reported enhanced recovery and decreased opioid consumption after mastectomy9. Although
SAP block has been extensively studied for breast surgery, RIPB in spite of
being efficacious for post-operative analgesia after major thoracic surgery, is
still under-evaluated for MRM. Though they have been compared with different
blocks, literature is sparse with regards to the comparable analgesic efficacy
of SAP and RIPB in MRM. This study is therefore being planned to compare the
efficacy of the two blocks in MRM. |