| CTRI Number |
CTRI/2018/11/016389 [Registered on: 20/11/2018] Trial Registered Prospectively |
| Last Modified On: |
20/11/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
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Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Erector Spinae Plane (ESP) block in breast surgery |
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Scientific Title of Study
|
Ultrasound Guided Regional Blocks for Breast Surgery; A Comparison of Erector Spinae Plane (ESP), Thoracic Paravertebral (TPVB) and Serratus Anterior Plane (SAP) Blocks in Randomized Controlled Trial. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Praveen Talawar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No-5011
5th floor, Teaching block
Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS,
Ansari Nagar
New Delhi-110029
South
DELHI
110029
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No-5011
5th floor, Teaching block
Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS,
Ansari Nagar
New Delhi-110029
DELHI
110029
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveen Talawar |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS New Delhi |
| Address |
Room No-5011
5th floor, Teaching block
Department of Anaesthesiology, Pain Medicine and Critical Care
AIIMS,
Ansari Nagar
New Delhi-110029
DELHI
110029
India |
| Phone |
9654162941 |
| Fax |
|
| Email |
praveenrt64@gmail.com |
|
|
Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
AIIMS New Delhi |
| Address |
Roo No 5011
5th floor
Teaching Block
Department of Anaesthesiology
AIIMS New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
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Details of Secondary Sponsor
|
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Countries of Recruitment
|
India |
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Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Praveen Talawar |
AIIMS New Delhi |
Room No-5011
5th Floor, Teaching Block
Department of Anaesthesiology, Pain Medicine & Critical Care
AIIMS, New Delhi-110029
South
DELHI |
9654162941
praveenrt64@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, New Delhi |
Approved |
|
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Female patients, aged between 18-70 years of age undergoing any breast surgery, (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Erector Spinae Plane (ESP) Block |
In sitting position
A high-frequency linear ultrasound (US) transducer will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles would be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae.
Following local anaesthetic infiltration of the superficial tissues, a 10-cm 22-gauge block needle will be inserted in a cephalad-to-caudad direction until contact was made with the T5 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5–1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A 20ml of Ropivacaine (0.375%) would be injected after negative aspiration.
|
| Comparator Agent |
Serratus Anterior Plane (SAP) Block |
In supine position with arm abducted
A US probe will be placed in mid axillary line at 3rd intercostal space. US scanning will be performed to identify the subcutaneous tissue and serratus anterior muscle (SAM) in the surface plane, the intercostal muscles (external, internal and intimate) in the intermediate plane and the ribs, pleura and lung in the deep plane
In an in-plane approach, and in caudal to cranial direction, block needle will be inserted until the tip is placed between serratus anterior muscle and external intercostal muscle. A 20ml of ropivacaine (0.375%) would be injected after negative aspiration at level of 4th rib.
|
| Comparator Agent |
Thoracic Paravertebral Block (TPVB) |
In sitting position
The US probe will be placed at the marked point. The transverse processes and ribs are visualized as hyperechoic structures with acoustic shadowing below them. Once the transverse processes and ribs will be identified, the transducer will be moved slightly caudal into the intercostal space between adjacent ribs to identify the thoracic paravertebral space. The space appears as a wedge-shaped layer demarcated by the hyperechoic reflections of the pleura below and the internal intercostal membrane above. The thoracic paravertebral space will be identified at this point
At the puncture site, infiltration will be done with 2% lignocaine. The block needle will be inserted below the probe in an in-plane approach under ultrasound guidance to reach the paravertebral space under vision and a 20ml of ropivacaine (0.375%) would be injected after negative aspiration.
|
| Intervention |
Ultrasound Guided Regional Blocks (Erector Spinae Plane Block, Thoracic Paravertebral Block and Serratus Anterior Plane Block) for Breast Surgeries |
Each intervention will receive 20 ml of 0.375% ropivacaine before the induction of general anaesthesia |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Female |
| Details |
Female patients undergoing elective unilateral breast surgeries with or without axillary clearance.
Aged between 18-65 year of age
ASA (American Society of Anesthesiology) Physical status I and II patients
|
|
| ExclusionCriteria |
| Details |
Patients refusal to participate in the study
History of coagulation disorders, antiplatelet therapy, anticoagulant therapy.
Morbid obesity with BMI ≥35kg/m2
Thoracic vertebral anomalies and severe chest wall deformity
Known allergy to study drugs
Patients with infection at the site of proposed block
Pregnancy
Severe cardiac, renal and hepatic conditions
Thyrotoxicosis
Mental retardation
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
To compare the duration of analgesia produced by three regional anaesthetic techniques (ESP, TPVB and SAP blocks) in patients undergoing any breast surgery under general anaesthesia.
|
immediate post operative period (0 hour)
Then at 1st, 2nd, 4th, 6th, 12th, 18th and 24th hour of surgery |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Secondary Objectives
1. To compare the total rescue opioid or opioid equivalent drugs required in the first 24 hours after surgery.
2. To compare the complications associated with the three regional anaesthetic techniques.
|
At 0, 1, 2, 3,6, 12 and 24 hours |
|
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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)
|
01/12/2018 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
15. Forero M, Adhikary SD, Lopez H, Tsui C and Chin KJ. The erector spinar plane block: A novel analgesic technique in thoracic neuropathic pain. Reg Anesth Pain Med. 2016; 41(5): 621-7.
16. Chin KJ, Adhikary SD, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia 2017; 72: 452-60.
17. Chin KJ, L Malhas, A Perlas. The erector spinae plane block provides visceral abdominal analgesia in bariatric surgery. A report f 3 cases. Reg Anesth Pain Med. 2017;42(3): 372-376.
18. D. L. Hamilton, B. Manickam; Erector spinae plane block for pain relief in rib fractures. Br J Anaesth 2017; 118 (3): 474-475. doi: 10.1093/bja/aex013
19. Ueshima H, Otake H. Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. Journal of Clinical Anesthesia.2017;38:137.
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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Brief Summary
|
Erector
spinae plane (ESP) block is a recently described ultrasound guided technique
whereby injecting a local anaesthetic (LA) above or below the erector spinae muscles
at the level of 5th thoracic (T5) transverse process produced a
sensory blockade from T2 to T9 vertebral levels in cephalocaudad direction and
from a line 3 cm lateral to thoracic spine to mid-clavicular line in
anterior-posterior direction in a patient with thoracic neuropathic pain (15).
The axilla and medial aspect of the upper arm also exhibited sensory blockade.
The contrast study on the cadaver demonstrates the spread of dye to the immediate
vicinity of ventral and dorsal rami of spinal nerve roots (15). The erector spinae muscle extends along the length of the thoracolumbar
spine, and thus, this plane permits extensive cranio-caudal spread and coverage
of multiple dermatomes. The most significant advantage of the ESP block is its
simplicity and safety. The sonoanatomy is easily recognizable, and there are no
structures at risk of needle injury in the immediate vicinity. The technique
also lends itself well to insertion of an indwelling catheter, which can be
used to extend the duration of analgesia as needed.
Several case reports described the efficacy of ESP
block and found to be superior in treating visceral pain and neuropathic pain
conditions. ESP block performed at the level of T5 transverse process is successfully used to treat severe
neuropathic pain in thoracic region in two cases (15). Bilateral
ESP block done at the level of T7 vertebral level produced good visceral analgesia
for patient undergoing laparoscopic mesh repair for ventral hernia (16), and pain
associated with bariatric surgery (17). The technique has been successfully
used to treat pain associated with multiple rib fractures (18), thoracic
vertebra surgery (19), and oncologic thoracic surgery in children (20).
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