| CTRI Number |
CTRI/2023/07/055701 [Registered on: 26/07/2023] Trial Registered Prospectively |
| Last Modified On: |
25/07/2023 |
| 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 SUPRACLAVICULAR AND INFRACLAVICULAR BLOCKS FOR HAND AND FOREARM SURGERIES: A COMPARISON |
|
Scientific Title of Study
|
A Comparison of ultrasound guided supraclavicular and infraclavicular blocks for hand and forearm surgeries |
| 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 Deepannita Sutradhar |
| Designation |
Associate Professor |
| Affiliation |
Silchar medical college and hospital |
| Address |
Department of Anaesthesiology and critical care, silchar medical college and hospital
Cachar
ASSAM
788014
India |
| Phone |
7002209146 |
| Fax |
|
| Email |
dipanitasutradhar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepannita Sutradhar |
| Designation |
Associate Professor |
| Affiliation |
Silchar medical college and hospital |
| Address |
Department of Anaesthesiology and critical care, silchar medical college and hospital
Cachar
ASSAM
788014
India |
| Phone |
7002209146 |
| Fax |
|
| Email |
dipanitasutradhar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ananya Hagjer |
| Designation |
PGT |
| Affiliation |
Silchar medical college and hospital |
| Address |
Department of Anaesthesiology and critical care, silchar medical college and hospital, silchar
Cachar
ASSAM
788014
India |
| Phone |
7099558723 |
| Fax |
|
| Email |
hagjer13@gmail.com |
|
|
Source of Monetary or Material Support
|
| Silchar medical college and hospital, silchar, cachar, Assam
pin-788014 |
|
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Primary Sponsor
|
| Name |
Silchar medical college and hospital |
| Address |
Silchar medical college and hospita;, ghungoor, silchar, cachar, asssam |
| Type of Sponsor |
Government medical college |
|
|
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 Deepannita Sutradhar |
Silchar medical college |
orthopedics department
Cachar
ASSAM |
7002209146
dipanitasutradhar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee of Silchar medical college and hospital |
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: S698||Other specified injuries of wrist,hand and finger(s), (2) ICD-10 Condition: S52||Fracture of forearm, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ultrasound guided infraclavicular block in hand and forearm surgeries |
This study aims to compare the onset of sensory block, motor block, time of achieving complete sensory block, and time of achieving competitive motor block in two groups of 120 patients. The study will also compare the time taken to visualize and identify anatomy of structures under USG guidance and evaluate block performance time, as well as adverse occurrences like pneumothorax, Horners syndrome, and inadvertent vascular puncture.
The total duration of study period will be 1 year.Route is infraclavicular. Total volume to be infiltrated is 40ml (max) in a single-shot technique. Average time taken for block performance is 5-10mins. Both block techniques will be performed under ultrasound guidance, with light anxiolysis provided before administration. The blocks will be performed using a 50-mm or 100mm stimuplex needle, with an anaesthetic solution of 0.75% ropivacaine and 2% lignocaine hydrochloride. The study will also monitor any negative outcomes, such as unintentional artery punctures, Horners syndrome, and pneumothorax. Block performance will be assessed using pin prick stimulation and modified bromage scale scores for sensory block and motor block. |
| Intervention |
Ultrasound guided supraclavicular block in hand and forearm surgeries |
The primary aim of this study will be to compare the two groups in terms of achieving the:
1) Onset of sensory block;
2) Onset of motor block;
3) Time of achieving complete sensory block;
4) Time of achieving compete motor block;
The secondary aim of this study will be to compare :
1) Time taken to visualize and identify anatomy of the structures(of the area of interest) under USG guidance;
2) to evaluate the block performance time as well as adverse occurrences including pneumothorax, Horners syndrome, and inadvertent vascular puncture.The study will be conducted on 120 patients.The total duration of study period will be 1 year. Each patient will be randomly placed in one of the two groups of 60 patients each.
Group-SCB - would receive infraclavicular block via ultrasound guided technique.
Also the block performance time will be noted. Furthermore, any negative outcomes like
a) an unintentional artery puncture,
b) Horners syndrome, and
c) pneumothorax will be monitored. 5. Method: Both block techniques will be done under ultrasound guidance. Light anxiolysis with midazolam 0.5–1 mg and nalbuphine 1-10 mg will be provided as needed before administration of the block. The blocks will be performed with the use of a 50-mm or 100mm stimuplex needle. The anaesthetic solution will consist of 0.75% ropivacaine (10ml) diluted into 20ml with distilled water and 2% lignocaine hydrochloride with 1:200,000 epinephrine (10ml) diluted up to 20ml with distilled water making a total volume of 40ml. Supraclavicular and infraclavicular blocks will be performed using a 8-MHz ultrasonic linear scanning head. For both blocks, the nervous and vascular structures will be optimally visualised and the needle will be inserted perpendicular to the skin surface, oriented towards the presumed nervous structures. The local anaesthetic solution will be administered in a single injection of 0.5 mL/kg up to a maximum of 40 mL after confirming correct needle placement in a single-shot technique. Route is infraclavicular. Average time taken for block performance is 5-10mins. Time will be noted for the onset and duration and block accuracy for each sensory and motor nerve blockade and the number of needle advancements will be noted.
6. Block performance will be assessed on the basis of following score for motor and sensory block.
I. Sensory block assessment will be done on the basis of pin prick stimulation and will be graded according to the following score:
a. Anaesthesia (no pain; no touch sensation): grade 2
b. Analgesia( no pain): grade 1
c. Pain (feels pain): grade 0
II. Motor Block will be assessed and graded according to Modified bromage scale:
a. Paralysis (complete motor block): grade 2
b. Paresis (reduced motor strength with movement of fingers only ): grade 1
c. No weakness (normal motor function of elbow, wrist and fingers): grade 0
|
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 or 2.
Elective hand and forearm surgeries.
Patients of either sex aged eighteen to sixty years.
Total body weight between forty-five to seventy five kgs .
|
|
| ExclusionCriteria |
| Details |
Allergy to local anaesthetics.
Pregnancy.
Patients with chest deformity & clavicle fracture.
Patients with significant pulmonary pathology.
Patients with coagulopathies.
Pre-existing motor and sensory deficit in the operative limb
Active infection at the site of the injection.
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
Onset of sensory block & motor block
Time of achieving complete sensory & motor block.
|
Onset of sensory block, motor block will be calculated at baseline at 0 mins, at 5 mins, 10mins, 15mins, at 20mins and at 30 mins.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken to visualize & identify anatomy of the structures(of the area of interest) under USG guidance
to evaluate the block performance time as well as adverse occurrences including pneumothorax, Horners syndrome, and inadvertent vascular puncture
|
0-24 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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 2 |
|
Date of First Enrollment (India)
|
05/08/2023 |
| 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 |
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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
|
Regional nerve block is a technique used to provide anesthesia for upper extremities surgeries, such as arm, forearm, and hand. It reduces the adverse effects of anesthetic drugs during general anesthesia and laryngoscopic stress response. Techniques for correct placement include eliciting paresthesia, peripheral nerve stimulator, and ultrasound guidance. A well-conducted regional anesthetic technique offers advantages over general anesthesia, such as maintaining awareness, avoiding polypharmacy, better hemodynamic stability, and excellent post-operative analgesia.
Supraclavicular and infraclavicular blocks are popular techniques for upper limb surgeries, with the supraclavicular brachial plexus block being a popular choice due to its quick onset and high success rate. However, it has higher complications like inadvertent vascular injections, pneumothorax, phrenic nerve palsy, and Horner’s syndrome.
Ultrasonography has rekindled interest in infraclavicular blocks, targeting the branches of the brachial plexus that innervate the arm, forearm, and hand. Infraclavicular blocks have fewer complications with ultrasound, are less invasive, and have a lower risk of complications. However, the plexus is deeper and the angle of approach is more acute, making synchronized visualization challenging for inexperienced hands and obese patients.
Although both supraclavicular and infraclavicular blocks can be used for upper limb surgeries, anesthesiologists often prefer supraclavicular over infraclavicular blocks due to technical difficulties and increased complications. Understanding the brachial plexus’s anatomy is essential for proper localization during regional anesthesia techniques. Ultrasonography has made it a valuable adjunct in peripheral nerve blocks, offering advantages such as direct visualization of nerves and surrounding anatomy, continuous monitoring of needle tip and drug spread, and predicted speedier and safer infraclavicular blocks with ultrasound guidance. |