| CTRI Number |
CTRI/2025/02/080774 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
18/02/2025 |
| 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
|
Comparing Techniques: Selective Trunk Block vs. Corner Pocket Approach for Supraclavicular Brachial Plexus Block in upper limb surgeries |
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Scientific Title of Study
|
Comparison of Selective Trunk Block and Corner Pocket Approach of Supraclavicular Brachial Plexus Block : A Prospective 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 |
Salma Suman P |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8138815709 |
| Fax |
|
| Email |
salmasuman99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arshad Ayub |
| Designation |
Additional Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, Room No. 707A, 7th floor, Dr. RP Centre of Ophthalmic Sciences, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
9953542344 |
| Fax |
|
| Email |
drarshad2k1@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Salma Suman P |
| Designation |
Junior Resident (Academic) |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi
South
DELHI
110029
India |
| Phone |
8138815709 |
| Fax |
|
| Email |
salmasuman99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Pain Medicine and Critical Care, 5th floor, Academic block, All India Institute of Medical Sciences, Ansari Nagar East, New Delhi, Delhi, 110029 |
|
|
Primary Sponsor
|
| Name |
Arshad Ayub |
| Address |
Department of Anaesthesiology, Pain Medicine and Critical Care, Room No. 707A, 7th floor, Dr. RP Centre of Ophthalmic Sciences,
All India Institute of Medical Sciences, New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Department of Anaesthesiology Pain Medicine and Critical Care |
All India Institute of Medical Sciences, Ansari Nagar , New Delhi, 110029 |
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Salma Suman P |
All India Institute of Medical Sciences, New Delhi |
Department of Anaesthesiology, Pain Medicine and Critical Care, All India Institute of Medical Sciences, New Delhi, 110029
South
DELHI |
8138815709
salmasuman99@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 |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Corner pocket approach of Supraclavicular Brachial Plexus Block |
Corner pocket approach of Supraclavicular Brachial Plexus Block is a nerve block in upper limb surgeries in which local anesthetic is injected to the corner pocket between subclavian artery and first rib where elements of brachial plexus are found.
Procedure:
Group C will receive conventional corner pocket approach of supraclavicular brachial plexus block. With the patient lying supine and head tilted to the opposite side, a high frequency linear probe (6-13 MHz) will be placed in supraclavicular fossa and the corner pocket between inferolataeral side of subclavian artery and first rib where trunks and divisions of brachial plexus are present, appearing as a cluster of grapes is identified. After obtaining an adequate sonographic view, 20 ml of the same drug (1:1 ratio of 0.75% Ropivacaine and 2% Lignocaine with 1 mcg/kg Dexmedetomidine) will be injected at the corner pocket with a 5 cm,22 G needle after negative aspiration of blood.
The estimated duration of the intervention will be 15-30 minutes, depending on the ease of scanning and visualising each trunk and needling experience of the operator. |
| Intervention |
Selective Trunk Block |
Selective Trunk Block is a regional anaesthesia technique used in upper limb surgeries where we selectively identify all 3 trunks using Sequential Ultrasound Imaging Technique(SUIT) and block them separately.
Procedure:
Group S will undergo Sequential Ultrasound Imaging Technique (SUIT) followed by Selective Trunk Block (SeTB). With the patient lying supine and head tilted to the opposite side, a high frequency linear ultrasound probe (6-13 MHz) will be placed in supraclavicular fossa directly cranial to midpoint of clavicle to visualize brachial plexus applying as cluster of grapes on the posterolateral aspect of subclavian artery. The transducer will be then manipulated cranially and caudally to sequentially identify the following structures :
• C7 transverse process and ventral ramus
• C6 transverse process and ventral ramus
• C5 transverse process and ventral ramus
• Fusion of C5 and C6 ventral rami to form superior trunk
• Neural stack which include superior trunk, middle trunk and C8 ventral ramus
• Fusion of C8 and T1 ventral rami to form inferior trunk
After SUIT, sterile preparation of skin and probe will be done and local infiltration of local anaesthetic (2% Lignocaine) is given. Two injections of the drug (1:1 ratio of 0.75% Ropivacaine and 2% Lignocaine with 1 mcg/kg Dexmedetomidine) are given at the following sites with a 22G needle after negative aspiration of blood :
1. 13 ml of the drug is given at the neural stack between superior and middle trunk.
2. 7 ml of the drug is given in inferior trunk.
The estimated duration of the intervention will be 15-30 minutes, depending on the ease of scanning and visualising each trunk and needling experience of the operator. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. All adults posted for surgeries of distal humerus, elbow, forearm, wrist and hand.
2. Age group : 18-65 years
3. ASA grade - 1,2
4. Body mass index of 18 to 35 kg/sq.m |
|
| ExclusionCriteria |
| Details |
1. Patients not giving consent for the block
2. Patients not able to understand the procedure and risks associated with it
3. Known neuropathy or injury of musculocutaneous, radial, ulnar or median nerve
4. Abnormal neck or shoulder anatomy
5. Any history of previous surgery in supraclavicular or infraclavicular fossa
6. Patients with decreased mentation or altered sensorium
7. Patients with any local site infection
8. Any other surgical contraindications for regional anaesthesia
9. ASA grade 3 or more
10. Patients with local anaesthetic allergy
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of sensory blockade of median, radial, ulnar and musculocutaneous nerves in both groups |
5,10,15,20,25,30 minutes after nerve block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Comparison of motor blockade of median, radial, ulnar and musculocutaneous nerves in both groups |
5,10,15,20,25,30 minutes after nerve block |
| Comparison of time taken to perform block in both groups |
During the nerve block |
| Comparison of time taken to achieve sensory anaesthesia in both groups |
5,10,15,20,25,30 minutes after nerve block |
| Comparison of time taken to achieve motor blockade in both groups |
5,10,15,20,25,30 minutes after nerve block |
| Comparison of incidence of phrenic nerve palsy in each group |
Baseline (before giving nerve block) and 30 minutes after nerve block |
| Assessment of patient discomfort during the procedure by VAS score |
During nerve block |
| Success or feasibilty of discovering all three trunks in selective trunk block |
During nerve block |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
01/03/2025 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Supraclavicular
brachial plexus block (BPB) is the most used regional anesthesia technique in
upper limb surgeries. It is considered equivalent to spinal anesthesia in these
surgeries due to its rapid onset, reliable, effective and comprehensive block
of all the necessary nerves of upper limb. Ultrasound guided corner pocket
approach is the recommended and most widely practiced technique for
supraclavicular BPB. In this approach, a single injection of local anesthetic
is given at the angle formed between the
first rib and inferolateral side of subclavian artery 1. The limitation
of this approach, however, is the deeper location of T1 ventral ramus and inferior
trunk compared to superior and middle trunks. This often results in inferior trunk
(C8-T1, ulnar nerve) sparing. Previous studies, also concurred this and
observed an ulnar nerve sparing of 5-30%
with this approach, which can result in incomplete anesthesia for these surgeries.2-5
With
the recent updates in ultrasound resolution, it is now feasible to isolate and
locate all three trunks of brachial plexus. Dr Karmakar et al. recently
described one such method called as Sequential Ultrasound Imaging Technique
(SUIT) to identify all the three trunks.4,5 This enables us to block each trunk separately,
making Selective Trunk Block (SeTB) a potential approach to provide comprehensive
and complete anesthesia or analgesia for all the patients undergoing any upper
limb surgery. In this technique, we sequentially identify ventral rami of all
the roots and formation of all trunks of brachial plexus.6,7 After
obtaining an appropriate ultrasound view, local anesthetic is deposited two
sites – one between superior and middle trunk, another at the inferior trunk.
We
therefore hypothesize that an approach to selectively identify and block all
three trunks should be able to produce a comprehensive and complete anasethesia
for all upper limb surgeries without ulnar nerve sparing common with corner
pocket approach. REFERENCES - Soares LG, Brull R, Lai J, Chan VW. Eight ball,
corner pocket: the optimal needle position for ultrasound-guided
supraclavicular block. Reg Anesth Pain Med. 2007;32(1):94-95.
doi:10.1016/j.rapm.2006.10.007
- Trivedi,
Saurabh; Gupta, Srishti1; Bhardwaj, Hemendra; Sahoo, Tapan Kumar; Gupta, Seema;
Trivedi, Gaurav2. Efficacy of intertruncal and corner-pocket approaches of
ultrasound-guided supraclavicular block in terms of ulnar nerve blockade: A
randomised controlled study. Indian Journal of Anaesthesia 67(9):p 778-784,
September 2023. | DOI: 10.4103/ija.ija_45_23
- Kukreja
P, Kofskey AM, Ransom E, et al. Comparison of Supraclavicular Regional Nerve
Block Versus Infraclavicular Regional Nerve Block in Distal Radial Open
Reduction and Internal Fixation: A Retrospective Case Series. Cureus.
2022;14(4):e24079. Published 2022 Apr 12. doi:10.7759/cureus.24079
- Fredrickson
MJ, Patel A, Young S, Chinchanwala S. Speed of onset of ’corner pocket
supraclavicular’ and infraclavicular ultrasound guided brachial plexus block: a
randomised observer-blinded comparison. Anaesthesia. 2009;64(7):738-744.
doi:10.1111/j.1365-2044.2009.05918.x
- Jo Y,
Park J, Oh C, et al. Comparison of the ulnar nerve blockade between
intertruncal and corner pocket approaches for supraclavicular block: a
randomized controlled trial. Korean J Anesthesiol. 2021;74(6):522-530.
doi:10.4097/kja.21028
- Karmakar
MK, Pakpirom J, Songthamwat B, Areeruk P. High definition ultrasound imaging of
the individual elements of the brachial plexus above the clavicle. Reg
Anesth Pain Med. 2020;45(5):344-350. doi:10.1136/rapm-2019-101089
- Songthamwat
B, Pakpirom J, Pangthipampai P, Vorapaluk P, Karmakar MK. Reliability of a
sequential ultrasound imaging technique (SUIT) to identify the individual
elements of the brachial plexus above the clavicle. Reg Anesth Pain Med.
2021;46(12):1107-1109. doi:10.1136/rapm-2021-102701
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