| CTRI Number |
CTRI/2021/03/032212 [Registered on: 23/03/2021] Trial Registered Prospectively |
| Last Modified On: |
22/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 different blocks in upper limb surgeries below elbow. |
|
Scientific Title of Study
|
Comparision of ultrasound guided costoclavicular versus paracoracoid approaches of infraclavicular block for upper limb surgeries; A double blinded randomized control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ramesh Koppal |
| Designation |
Professor |
| Affiliation |
S N Medical college Bagalkot |
| Address |
Dept of Anaesthesia,
S N Medical college, Navanagar
Bagalkot
Dept of Anaesthesia,
S N Medical college, Navanagar
Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
9845504515 |
| Fax |
|
| Email |
rameshkoppaldr@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Koppal |
| Designation |
Proffessor |
| Affiliation |
S N Medical college Bagalkot |
| Address |
Dept of Anaesthesia,
S N Medical college, Navanagar
Bagalkot
Dept of Anaesthesia,
S N Medical college, Navanagar
Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
9845504515 |
| Fax |
|
| Email |
rameshkoppaldr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aishwarya Guddad |
| Designation |
PG in Anaesthesia |
| Affiliation |
S N Medical college Bagalkot |
| Address |
Dept of Anaesthesia,
S N Medical college, Navanagar
Dept of Anaesthesia,
S N Medical college, Navanagar
Bagalkot
Bagalkot
KARNATAKA
587102
India |
| Phone |
8197194984 |
| Fax |
|
| Email |
aishwaryaguddad95@gmail.com |
|
|
Source of Monetary or Material Support
|
| S N Medical college and HSK hospital |
|
|
Primary Sponsor
|
| Name |
Dept of Anaesthesia |
| Address |
1ST Floor, Major OT complex, S N Medical college Bagalkot |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ramesh Koppal |
S N Medical college and HSK Hospital |
Orthopaedic ot complex ground floor
Bagalkot
KARNATAKA |
9845504515
rameshkoppaldr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SNMC-INSTITUTIONAL ETHICS COMMITTEE ON HUMAN SUBJECTSRESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M848||Other disorders of continuity of bone, (2) ICD-10 Condition:M958||Other specified acquired deformities of musculoskeletal system. Ayurveda Condition: Not applicable, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Costoclavicular approaach for infraclvicular block |
In the costoclavicular space, the axillary artery is identified underneath the subclavius muscle .The three cords of brachial plexus will be visualised lateral to the artery. If the cephalic vein (or thoracoacromial artery) is visualised, the ultrasound transducer is tilted slightly cephalad in order to provide an adequate sonographic view of the costoclavicular space and the three cords of the brachial plexus . After skin infiltration, using an in-plane technique and a lateral to medial direction , the block needle is advanced until its tip is located in the middle of all three cords. |
| Comparator Agent |
Paracoracoid approach for infraclavicular block |
After skin infiltration, using an in plane technique and a cephalad to caudal direction, the block needle will be advanced until its tip is located dorsal to the axillary artery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA physical status I and II
2. Age between 18 to 80 years.
3. Body mass index of <30 kg /m2
4. Patients undergoing upper limb surgeries, distal to elbow.
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal to give consent.
2. Sepsis
3. Coagulopathy
4. Hepatic or renal failure
5. Prior surgery in the Infraclavicular fossa
6. Patients allergic to local anaesthetics
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Costoclavicular may be superior to Paracoracoid block |
24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| There might be lesser incidence of hemidiaphgramatic paralysis in case of costoclavicular block |
24 hours |
|
|
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" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
25/03/2021 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Leurcharusmee-P, Elgueta-MF, Tiya Prasertkul-W, Sotthisopha-T, et al. Randomized comparison between costoclavicular and parachoracoid ultrasound- guided infraclavicular block for upper limb surgery. Can J Anaesthesia 2017 64:617-625.
Beh ZY, Hasan MS. Ultrasound-guided costoclavicular approach infraclavicular brachial plexus block for vascular access surgery. The Journal of Vascular Access. 2017 Sep;18(5):e57-61.
Luo Q, Yao W, Chai Y, Chang L, Yao H, Liang J, Hao N, Guo S, Shu H. et al. Comparison of ultrasound-guided supraclavicular and costoclavicular brachial plexus block using a modified double-injection technique: a randomized non-inferiority trial. Bioscience Reports. 2020 Jun 26;40(6).
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Brachial plexus block is an effective technique for upper extremity surgeries. This block can be executed using a variety of approaches. Here we are comparing 2 different approaches for Infraclavicular block (1-paracoracoid 2-costoclavicular) mainly for upper limb surgeries distal to elbow. In the conventional Para Coracoid approach,the needle is placed in the lateral Infraclavicular fossa where the cords are in close proximity to the axillary artery, hence there will be high chance of vascular breech in case of Para coracoid approach.³ .And this technique is also technically challenging in patients with increased Body mass index. In this study we are comparing Paracoracoid versus costoclavicular infraclavicular block in terms of onset, duration and incidence of Hemidiaphragmatic paralysis in both the studies. Primary objective: To compare the onset and duration of blocks in the costoclavicular and paracoracoid approaches of Infraclavicular block.
Secondary objective:To assess the incidence of Hemidiaphragmatic paralysis between costoclavicular and paracoracoid approaches of Infraclavicular block. |