| CTRI Number |
CTRI/2021/08/035491 [Registered on: 06/08/2021] Trial Registered Prospectively |
| Last Modified On: |
03/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
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Public Title of Study
|
A Randomised controlled trial of infraclavicular versus costoclavicular approach of Infraclavicular block in upper limb surgery |
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Scientific Title of Study
|
Randomised controlled trial to assess the postoperative analgesic efficacy of continuous paracoracoid versus costoclavicular approach to infraclavicular block in upper limb surgery |
| Trial Acronym |
|
|
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 |
Priyanka sagar |
| Designation |
Postgraduate student |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Main OT Complex
Department of Anaesthesiology
Lady Hardinge medical college
Central
DELHI
110001
India |
| Phone |
|
| Fax |
|
| Email |
96priyankasagar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Nitin hayaran |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Main OT Complex
Department of Anaesthesiology
Lady Hardinge Medical College
Central
DELHI
110001
India |
| Phone |
011-23408259 |
| Fax |
|
| Email |
nhayaran97@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nitin hayaran |
| Designation |
Professor |
| Affiliation |
Lady Hardinge Medical College |
| Address |
Main OT Complex
Department of Anaesthesiology
Lady Hardinge Medical College
Central
DELHI
110001
India |
| Phone |
011-23408259 |
| Fax |
|
| Email |
nhayaran97@gmail.com |
|
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Source of Monetary or Material Support
|
| Lady HARDINGE medical college |
|
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Primary Sponsor
|
| Name |
Lady hardinge medical college |
| Address |
Shaheed Bhagat Singh marg
New Delhi |
| 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 |
| priyanka sagar |
Lady Hardinge Medical College |
Main OT Complex
Department of Anaesthesiology
Central
DELHI |
9971498506
96priyankasagar@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee of human resources |
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: M849||Disorder of continuity of bone, unspecified, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group1 infraclavicular block (Paracoracoid approach) |
Group 1 (Paracoracoid approach)
Transducer will be positioned medially to the coracoid process below clavicle in parasagittal axis to identify the axillary artery and cords of BP surrounding the artery. Tuohy’s needle (18G) will be inserted in-plane from the cephalad aspect of probe, with the insertion point just inferior to the clavicle.
After careful aspiration, 0.9% saline will be injected to confirm the proper needle placement and spread. The initial bolus dose of 20ml of 0.5% Bupivacaine will be injected. A flexible 19G Epidural style catheter will now be threaded and advanced 2-3 cm beyond the needle tip under direct visualization of USG.
Intermittent boluses with 5ml of 0.5% Bupivacaine will be given every 1.5 hour till the end of the surgery. A disposable infusion pump will be used for postoperative continuous local anaesthetic infusion via catheter of 0.125% Bupivacaine at 5ml/hr for the next 24hours. IV Paracetamol 1000 mg will be given 5 min prior to end of surgery and thereafter every 6 hours till 24 hours.
Pain assessment on rest at 0, 6, 12 and 24 hours postoperatively using NRS will be done. Pain assessment on limb movement at 0, 6, 12 and 24 hours postoperatively using NRS. .
Patients will be instructed to ask for rescue opioid analgesics if they report pain of NRS 4 or more. IV Tramadol 1mg/kg will be given.
Catheter will be removed under all aseptic precautions after completion of postoperative 24hours. |
| Intervention |
Group2 infraclavicular approach (Costoclavicular approach) |
Group 2 (Costoclavicular approach) A transverse scan will be performed immediately below the mid-section of the clavicle and over the medial infraclavicular fossa.
After careful aspiration, 0.9% saline will be injected to confirm the proper needle placement and spread. The initial bolus dose of 20ml of 0.5% Bupivacaine will be injected. A flexible 19G Epidural style catheter will now be threaded and advanced 2-3 cm beyond the needle tip under direct visualization of USG.
Intermittent boluses with 5ml of 0.5% Bupivacaine will be given every 1.5 hour till the end of the surgery.
A disposable infusion pump will be used for postoperative continuous local anaesthetic infusion via catheter of 0.125% Bupivacaine at 5ml/hr for the next 24hours. IV Paracetamol 1000 mg will be given 5 min prior to end of surgery and thereafter every 6 hours till 24 hours.
Pain assessment on rest at 0, 6, 12 and 24 hours postoperatively using NRS will be done. Pain assessment on limb movement at 0, 6, 12 and 24 hours postoperatively using NRS. .
Patients will be instructed to ask for rescue opioid analgesics if they report pain of NRS 4 or more. IV Tramadol 1mg/kg will be given.
Catheter will be removed under all aseptic precautions after completion of postoperative 24hours. |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
All patients>18yrs of ASA1 and 2 of either sex. |
|
| ExclusionCriteria |
| Details |
1.Upper limb surgeries above mid humerus level.
2. Any known drug allergies.
3.Contraindication to nerve block like coagulopathy, bleeding diathesis and local infections.
4.Preexisting neurological deficit. |
|
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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 and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Mean opioid consumption(mg/kg) at the end of 24 hours poatoperatively in both paracoracoid and costoclavicular infraclavicular block groups. |
Mean opioid consumption(mg/kg) at the end of 24 hours poatoperatively in both paracoracoid and costoclavicular infraclavicular block groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the Pain score (Numerical Rating Scale (NRS)) on rest at 0,6,12 and24 hours postoperatively in both groups.
2. To compare the Pain score (NRS) on limb movement at 0,6,12 and 24 hours postoperatively in both groups.
3. To assess any catheter related complications (catheter dislodgement, erythema, hematoma at the site of catheter insertion) in both groups. |
0,6,12 and 24 hours postoperatively |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
13/08/2021 |
| 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="1"
Days="5" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Results will be published in a scientific journal |
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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
|
Brachial plexus (BP) blocks are the most common anaesthesia modality for conducting upper limb surgery as they reliably provide analgesia and immobilisation to the target limb.Ultrasound(USG) is now increasingly used to guide site-specific regional anaesthesia with improved safety, efficacy and visual affirmation of the block given.
The infraclavicular block (ICB) is the method of accomplishing BP anaesthesia below the level of clavicle where the axillary vessel and the cords of the BP lie deep to the pectoralis muscles just inferior and slightly medial to the coracoid process.
Single shot plexus block although it produces effective anaesthesia has a limited duration of post-operative analgesia and number of agents have been tested in order to prolong analgesia duration. The use of perineural catheters is an effective option to improve and prolong the post-operative analgesic effect.
Conventially, the ICB is given through paracoracoid approach with good efficacy. Recently the costoclavicular approach to ICB has been described. The single shot costoclavicular ICB has been found to be equally effective as single shot paracoracoid ICB. Considering this costoclavicular space (CCS) being covered by pectoralis major and subclavius muscle and BP cords being clustered together here which can be seen in single transverse sonogram hence, this may be the ideal location for continuous perineural BP block.
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