| CTRI Number |
CTRI/2024/09/073234 [Registered on: 02/09/2024] Trial Registered Prospectively |
| Last Modified On: |
30/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of analgesic efficacy between Erector spinae block and Rhomboid intercostal sub-serratus block . |
|
Scientific Title of Study
|
Comparison of analgesic efficacy between ultrasound guided Rhomboid Intercostal Sub-Serratus Block and Erector Spinae Plane Block for Postoperative pain in Modified Radical Mastectomy |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yadukumar M M |
| Designation |
Junior Resident |
| Affiliation |
Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8861558819 |
| Fax |
|
| Email |
yadukumarmm09@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashpal Singh |
| Designation |
Professor |
| Affiliation |
Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9918424416 |
| Fax |
|
| Email |
dryashtrauma@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashpal Singh |
| Designation |
Professor |
| Affiliation |
Institute Of Medical Sciences |
| Address |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9918424416 |
| Fax |
|
| Email |
dryashtrauma@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
| material support only by
Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan
Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH
221005
INDIA |
|
|
Primary Sponsor
|
| Name |
Institute of medical sciences |
| Address |
Institute of medical sciences, Banaras Hindu University,Varanasi 221005 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| YADUKUMAR M M |
Institute Of Medical Sciences, BHU |
Department of Anaesthesiology office, 1st floor, Sir Sunderlal Hospital, Banaras Hindu University, Pandit Madan Mohan Malviya Road, Kabir colony
Varanasi
UTTAR PRADESH |
8861558819
yadukumarmm09@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Of Medical Sciences_ethics _committee |
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 |
Erector spinae plane block |
: Patients will be placed in lateral decubitus position with the operation site up,
the vertebrae will be counted from cephalad to caudal direction until reaching T5 spinous
process. The ultrasound probe will be placed vertically 3 cm lateral to the T5 spinous
process. The transverse process has a square form contour as compared to rib which is
rounded form contour. Three muscles will be identified superficial to the hyperechoic
transverse process shadow as follows: trapezius, rhomboid major, and erector spinae.
Under complete aseptic precautions, the needle will be introduced from superior to
inferior direction in-plane until the tip lay deep to erector spinae muscle. 0.5-1 mL of non-
active fluid will be injected to confirm correct needle tip position by visualizing spread
under erector spinae muscle and after confirming a total of 0.6ml/kg of 0.375%
Ropivacaine will be injected. |
| Comparator Agent |
Rhomboid Intercostal sub-serratus block |
Patients will be placed in lateral decubitus position with the operating side
lying superiorly. The ipsilateral arm was abducted from chest to move scapula laterally, a
linear ultrasound probe was placed in sagittal plane at T5-6 level, just medial to scapula,
to identify the trapezius, rhomboid major, and intercostal muscles. A 21-gauge needle was
inserted in the plane between the rhomboid major and intercostal muscles in a cephalad
to caudad direction, and Half dose of 0.6ml/kg of .375% ropivacaine was injected.
Thereafter, the ultrasound probe was moved caudally and laterally to identify the tissue
plane between serratus anterior and external intercostal muscles for the sub-serratus
block at the T8-9 level. The needle was advanced from its previous position, and an
remaining half of 0.6ml/kg of 0.375% ropivacaine was injected. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
56.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient with diagnosis of breast cancer and ASA grade 1 and 2. |
|
| ExclusionCriteria |
| Details |
1.known coagulopathy.
2.allergic to the study drug.
3.hepatic or renal dysfunction.
4.history of receiving anticoagulant treatment.
5.history of chronic opioid consumption.
6.Redo surgeries.
|
|
|
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 |
To compare post-operative NRS score between Rhomboid intercostal sub-serratus
block versus Erector spinae plane block. |
0 min,30 mins,60 mins,2 hrs,6 hrs,12 hrs and 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare intraoperative hemodynamic stability between Rhomboid intercostal
sub-serratus block versus Erector spinae plane block. |
Systolic blood pressure,Diastolic blood pressure,Heart rarte,Mean arterial pressure at baseline,after induction,after block,5min,10min,15min,30min
60min,90min,120min and fetanyl consumption intraoperatively. |
To compare total rescue analgesia dose needed between the two groups in postoperative period.
|
rescue analgesia-Tramadol 1.5 mg/kg;maximum dose of 3mg/kg over 24 hrs.
Adequate analgesia-NRS less than 4 |
| To compare the Needle visibility Score between the two groups |
Score 1 – Complete path of needle visualised.
Score 2 – Some part of needle visualised.
Score 3 – Some part of needle visualised with tissue movement.
Score 4 – Some part of needle visualised with hydro dissection and tissue movement.
Score 5 – Nothing is visualised, reinsertion required. |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/10/2024 |
| 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="1"
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
|
One day prior to the scheduled surgery, all the patients will be instructed on how to
evaluate their own pain by using a 10-cm visual analog pain scale (0=no pain, 10=
maximum pain imaginable).
After an 8 h fast, the patients will be taken into the operation theatre, where an 18-gauge
intravenous (IV) cannula will be secured and all ASA standard monitors will be applied.
Before induction the patients will be placed in a lateral decubitus position and one of the
two regional blocks will be performed.
RISS Block: Patients will be placed in lateral decubitus position with the operating side
lying superiorly. The ipsilateral arm was abducted from chest to move scapula laterally, a
linear ultrasound probe was placed in sagittal plane at T5-6 level, just medial to scapula,
to identify the trapezius, rhomboid major, and intercostal muscles. A 21-gauge needle was
inserted in the plane between the rhomboid major and intercostal muscles in a cephalad
to caudad direction, and Half dose of 0.6ml/kg of .375% ropivacaine was injected.
Thereafter, the ultrasound probe was moved caudally and laterally to identify the tissue
plane between serratus anterior and external intercostal muscles for the sub-serratus
block at the T8-9 level. The needle was advanced from its previous position, and an
remaining half of 0.6ml/kg of 0.375% ropivacaine was injected.
ESP Block: Patients will be placed in lateral decubitus position with the operation site up,
the vertebrae will be counted from cephalad to caudal direction until reaching T5 spinous
process. The ultrasound probe will be placed vertically 3 cm lateral to the T5 spinous
process. The transverse process has a square form contour as compared to rib which is
rounded form contour. Three muscles will be identified superficial to the hyperechoic
transverse process shadow as follows: trapezius, rhomboid major, and erector spinae.
Under complete aseptic precautions, the needle will be introduced from superior to
inferior direction in-plane until the tip lay deep to erector spinae muscle. 0.5-1 mL of non-
active fluid will be injected to confirm correct needle tip position by visualizing spread
under erector spinae muscle and after confirming a total of 0.6ml/kg of 0.375%
Ropivacaine will be injected.
After the block is performed the patients will be positioned supine again.
General anaesthesia will be induced with intravenous (IV) Inj. midazolam 25-50 mcg/kg,
Inj. fentanyl 1-2 mcg/kg and inj. propofol 1-2.5 mg/kg and intubation will be done after
administering inj. vecuronium bromide 0.1 mg/kg IV for muscle relaxation. The lungs will
be ventilated to maintain an end-tidal carbon dioxide of 30-35 mmHg. Anaesthesia will be
maintained with oxygen and isoflurane (1-2 MAC).
At the end of surgery, inj. ondansetron 0.1mg/kg will be given and muscle relaxation will
be reversed with inj. neostigmine 50 mcg/kg and inj. glycopyrrolate 10 mcg/kg. The
trachea will be extubated and the patients will be transferred to post-anaesthetic care
unit.
For rescue analgesia (when the VAS score will be ≥ 4) in postoperative period, injection
tramadol 100 mg will be given. The duration of analgesia will be the time from
administration of block to the first use of rescue analgesic.
The obtained data will be recorded and the results will be statistically analyzed by appropriate statistical method.A p value of 0.05 will be considered as significant |