| CTRI Number |
CTRI/2022/01/039448 [Registered on: 14/01/2022] Trial Registered Prospectively |
| Last Modified On: |
26/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
ULTRASOUND GUIDED COMPARISON BETWEEN TWO METHODS OF REGIONAL NERVE BLOCK FOR UPPER LIMB SURGERIES. |
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Scientific Title of Study
|
COMPARISON OF ULTRASOUND-GUIDED LATERAL AND MEDIAL APPROACH TO COSTOCLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB SURGERIES. |
| 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 Zahida Aziz |
| Designation |
Junior Resident, Department of Anaesthesiology and Critical Care |
| Affiliation |
Government Medical College and Hospital, Bakshi Nagar Jammu |
| Address |
Department of Anaesthesiology and Critical Care,
GMC.
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
08825015646 |
| Fax |
|
| Email |
zahidaaziz777@gmail.com |
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Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Mahajan |
| Designation |
Associate Professor, Department of Anaesthesiology and Critical Care. |
| Affiliation |
Government Medical College and Hospital, Bakshi Nagar Jammu |
| Address |
Department of Anaesthesiology and Critical Care, GMC.
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
09419141263 |
| Fax |
|
| Email |
drmahajanr@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Zahida Aziz |
| Designation |
Junior Resident, Department of Anaesthesiology and Critical Care |
| Affiliation |
Government Medical College and Hospital, Bakshi Nagar Jammu |
| Address |
Department of Anaesthesiology and Critical Care, GMC.
Jammu
JAMMU & KASHMIR
180001
India |
| Phone |
08825015646 |
| Fax |
|
| Email |
zahidaaziz777@gmail.com |
|
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Source of Monetary or Material Support
|
| Government Medical College and Hospital,Bakshi Nagar Jammu. |
|
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Primary Sponsor
|
| Name |
Government Medical College and Hospital |
| Address |
Maheshpura Chowk, Bakshi Nagar, Jammu 180001 |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
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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 |
| Dr Zahida Aziz |
Government Medical College and Hospital, Bakshi Nagar Jammu |
Department of Anaesthesiology and Critical Care, Government Medical College, Jammu.
Jammu
JAMMU & KASHMIR |
08825015646
zahidaaziz777@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| GMC Institute Ethics Committee |
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: 4||Measurement and Monitoring, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Comparator Agent |
Lateral approach of costoclavicular block
|
A 6-13 MHz linear ultrasound (US) Transducer, 22 G 9-cm block needle and 20ml of 0.5% ropivacaine and 0.5 ml of 1:2,00,000 epinephrine will be used for all subjects. Patients will be placed in a supine position with the surgical limb in 90 degree abduction. The US probe will be placed immediately below and parallel to middle one third of the clavicle. The transducer will be tilted slightly cephalad to visualize the costoclavicular space. Ultrasound images will be optimised until all the three cords are visualized in a single USG window. Brachial plexus will be visualized lying lateral to the first part of axillary artery sandwiched between the pectoralis major and subclavius muscle anteriorly and serratus anterior muscle overlying the second rib posteriorly. Doppler will be done before needling. After skin infiltration with plain 0.2% lignocaine, the block needle will be advanced in a lateral to medial direction until its tip is in the middle of all three cords and 20.5 ml of pre-mixed drug (20ml of 0.5% ropivacaine and 0.5 ml of 1:2,00,000 epinephrine) is injected after aspirating to prevent vascular entry. After injecting the pre-mixed drug through the block needle, measurements of brachial plexus blockade( both sensory and motor) will be carried out every 5 minutes until 30 minutes by a blinded observer.
|
| Intervention |
Medial approach of costoclavicular block
|
A 6-13 MHz linear US Transducer, 22 G 9-cm block
Needle and 20ml of 0.5% ropivacaine and 0.5 ml of 1:2,00,000 epinephrine will be used for all subjects. Patients will be placed in a supine position with the surgical limb in 90 degree abduction. The US probe will be placed immediately below and parallel to middle one third of the clavicle. The transducer will be tilted slightly cephalad to visualize the costoclavicular space. Ultrasound images will be optimized until all the three cords are visualized in a single USG window. Brachial plexus will be visualized lying lateral to the first part of axillary artery sandwiched between the pectoralis major and subclavius muscle anteriorly and the serratus anterior muscle overlying the second rib posteriorly. Doppler will be done before needling. After skin infiltration with plain 0.2% lignocaine, the block needle will be advanced in a medial to lateral direction, until its tip is in the middle of all three cords and 20.5 ml of pre-mixed drug (20ml of 0.5% ropivacaine and 0.5 ml of 1:2,00,000 epinephrine) is injected after aspirating to prevent vascular entry. After injecting the pre-mixed drug through the block needle, measurements of brachial plexus blockade(both sensory and motor) will be carried out every 5 minutes until 30 minutes by a blinded observer.
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1) Age from -18 years to 80 years giving informed written consent to participate in the study. 2) Gender – Both. 3) Patients of ASA Grade I / ASA Grade II. 4) Patients undergoing surgery of elbow, forearm, wrist and hand. 5) Body mass index of 18 to 35. |
|
| ExclusionCriteria |
| Details |
1.Patients who refuse to participate in the study.
2.Patients with coagulopathy, on anticoagulant therapy and sepsis.
3.Patient allergic to local anaesthetic agents.
4.Patient with pre-existing neuropathies.
5.Patients who had surgeries around infraclavicular fossa.
6.Patient with local infection around the needle site.
7.Psychiatric disorder
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Performance time
|
5-10 mins
|
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Block onset time, total anaesthesia time,number of needle passes, anesthesia success, performer difficulty, patient satisfaction and complications |
5,10,15,20,25,30 mins |
|
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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" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
01/02/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
Modification(s)
|
Introduction · Ultrasound guided costoclavicular brachial plexus block (CC-BPB) is emerging as a promising infraclavicular approach as lateral, medial and posterior cord are superficial and closely packed together in this region. · The conventional approach i.e lateral approach to costoclavicular block (CCB) may not be successful in some cases. Hence, the need for an alternative approach. The difficulty in performing lateral approach to costoclavicular block are 1. The coracoid process acting as an obstacle and 2. Guiding the needle toward the vessels and pleura. These structures can be avoided by taking a medial approach, which means going from inside to outside. · Further one needs to have an alternate to each approach as tumours, anatomical variations, and anomalies may mandate either of the two techniques. · The present study will be undertaken to determine the viability of the medial approach to CCB as an alternative to lateral approach to CCB and the goal of this study is to analyse and compare the block performance time between medial and lateral approaches to CCB. Primary objective · To compare the performance time between the medial and lateral approaches of ultrasound guided costoclavicular brachial plexus block for upper limb surgeries. Secondary objectives · To compare the block onset time, total anaesthesia time, anaesthesia success, number of needle passes, performer difficulty, patient satisfaction, rescue analgesia required post-operatively and complications between the two groups.
Study design : Prospective randomized double blinded parallel group trial performed at Department of Anaesthesiology and Critical Care GMC , Jammu. Since there are no studies that compare these two approaches, we decided to do an interventional prospective study. We will recruit a total of 60 patients with 30 patients in each group.
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