| CTRI Number |
CTRI/2022/03/041359 [Registered on: 24/03/2022] Trial Registered Prospectively |
| Last Modified On: |
14/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare regional anaesthesia given above clavicle with one given below the clavicle and shoulder, for providing pain relief in patients undergoing upper limb surgery under general anaesthesia |
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Scientific Title of Study
|
Comparative efficacy of ultrasound guided supraclavicular block versus combined infraclavicular block and suprascapular block in patients undergoing upper limb surgery under general anaesthesia: A Randomised 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 TIAJEM JAMIR |
| Designation |
JUNIOR RESIDENT, ANAESTHESIOLOGY |
| Affiliation |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, RISHIKESH |
| Address |
ROOM NO. 330, DEPARTMENT OF ANAESTHESIOLOGY, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, VIRBHADRA ROAD, RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8876450523 |
| Fax |
|
| Email |
tiajemjamir@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR DEEPAK SINGLA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
All India Institute of Medical Sciences, Rishikesh |
| Address |
ROOM NO. 016133, DEPARTMENT OF ANAESTHESIOLOGY, ,ALL INDIA INSTITUTE OF MEDICAL SCIENCES, VIRBHADRA ROAD, RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7505101162 |
| Fax |
|
| Email |
sngladpk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR DEEPAK SINGLA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
All india Institute of Medical Sciences, Rishikesh |
| Address |
ROOM NO. 016133, DEPARTMENT OF ANAESTHESIOLOGY, ,ALL INDIA INSTITUTE OF MEDICAL SCIENCES, VIRBHADRA ROAD, RISHIKESH
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7505101162 |
| Fax |
|
| Email |
sngladpk@gmail.com |
|
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Source of Monetary or Material Support
|
|
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Primary Sponsor
|
| Name |
AIIMS RISHIKESH |
| Address |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, VIRBHADRA ROAD, 249203, RISHIKESH, DEHRADUN, UTTARANCHAL |
| 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 TIAJEM JAMIR |
All India Institute of Medical Sciences, Rishikesh |
Room Number. 016125,
Department of Anaesthesia,
ALL INDIA INSTITUTE OF MEDICAL SCIENCES, VIRBHADRA ROAD, RISHIKESH
Dehradun
UTTARANCHAL |
8876450523
tiajemjamir@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL 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: S50-S59||Injuries to the elbow and forearm, (2) ICD-10 Condition: S60-S69||Injuries to the wrist, hand and fingers, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Infraclavicular block and suprascapular block with 0.25% bupivacaine |
The patient will be placed in sitting position for suprascapular block. Observing strict aseptic precaution, linear probe will be placed cephaled and parallel to the suprascapular spine to obtain a view of the suprascapular fossa and probe will be moved laterally to locate the suprascapular notch. The suprascapular nerve will be seen as a hyperechoic structure, a 23 guage bevel needle will be inserted along longitudinal axis and 10ml of 0.25%(25mg) bupivacaine will be injected after negative aspiration around the suprascapular nerve. For infraclavicular block, patient will be placed in supine position, linear probe will be placed in infraclavicular fossa medial to the coracoid process in order to obtain a short axis view of the axillary artery and proper visualization of the brachial plexus. The needle advancement will be in the parasagittal plane with continuous observation of the needle tip using the inplane technique. Considering the artery as a clock face with 12 Oclock ventral, 30ml of 0.25%(75mg) bupivacaine will be injected after negative aspiration between 8 and 9 oclock position around the cords of the brachial plexus. The maximum dose of bupivacaine will not exceed the toxic dose of 3mg/kg. The vitals(MAP,HR,RR,spO2) will be monitored for side effects such as anaphylaxis, hypotension, arryhthmias, apnea and hypoventilation. |
| Intervention |
Supraclavicular block with 0.25% bupivacaine |
The patient will be placed in supine position, with their arms by their sides and the head rotated rotated to the side opposite to that of the injection at an angle of 45 degrees. Observing strict aseptic precautions, a linear probe will be placed behind the clavicle in the supraclavicular fossa and pointed inferomedially. The subclavian artery and brachial plexus will be identified and a 23 gauge needle will be introduced from lateral to medial after visualizing the brachial plexus and placed in line with and parallel to the probe. The needle will be deep between the subclavian artery and the first rib and subsequently 30ml of 0.25%(dose:75mg) of bupivacaine will be injected and will be infiltrated around the brachial plexus after negative aspiration to check the spread of local anaesthesia. The maximum dose of bupivacaine will not exceed the toxic dose of 3mg/kg. The vitals(MAP, HR,RR , spO2) will be monitored for side effects such as anaphylaxis, hypotension, arryhthmias, apnea and hypoventilation. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.All males and females undergoing upper limb(midarm and below) surgeries under general anaesthesia
2. ASA classification I-III |
|
| ExclusionCriteria |
| Details |
1.Refusal to consent
2.Bleeding disorder
3.Local site infection or hematoma
4.Allergy to local anesthetics
5.Fracture or dislocation involving clavicle, shoulder or upper arm |
|
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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
|
Not Applicable |
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Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the total requirement of intravenous fentanyl in the first 24 hours after surgery with supraclavicular block versus combined infraclavicular and suprascapular block |
24 Hours |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the onset of sensory block with loss of pin prick sensation |
30 mins |
| Modified Bromage Scale to compare the time of onset of motor block |
30 mins |
| Compare the post-operative analgesia as measured by Numerical Rating Scores |
At 60 mins, 6 hours, 12 hours and 24 hours |
| Compare the relative incidence of complications |
24 hours |
|
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Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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 |
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Date of First Enrollment (India)
|
15/04/2022 |
| 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
|
Post operative analgesia results in patient comfort and satisfaction, early ambulation, reduced respiratory and cardiovascular complications, reduced risk of deep vein thrombosis, early recovery and low health care expenditure for patient and for the hospital. The Supraclavicular block is advantageous as the brachial plexus are highly packed in this approach and speed of onset is often rapidly achieved. The supraclavicular block is given ion the supraclavicular fossa in transverse orientation parallel to the clavicle and aimed inferior toward the ipsilateral thorax. It is suggested to provide effective anaesthesia for shoulder surgeries, proximal humerus and upper limb surgeries upto the fingertips. The Infraclavicular block is regional anaesthesia technique that blocks the cords of the brachial plexus below the clavicle. The disadvantages of the infraclavicular block is that it spares the shoulder nerves leading to pain during peri operative positioning and post operative pain of the shoulder. Suprascapular nerve provides 70% sensory fibres of the shoulder joint, capsule and overlying skin and also supplies motor branches to the supraspinatus and infraspinatus muscle, therefore providing excellent pain relief in the shoulder joint. The combination use of infraclavicular block and suprascapular nerve block has been successfully used as ab analgesia for proximal humerus surgeries, shoulder surgeries and infraclavicular block covering for upper extremity surgeries such as elbow, forearm and hand. |