| CTRI Number |
CTRI/2023/07/055564 [Registered on: 24/07/2023] Trial Registered Prospectively |
| Last Modified On: |
23/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Evaluation of 2 approaches of infraclavicular nerve block using ultrasound, for surgeries of the upper limb. |
|
Scientific Title of Study
|
Comparative evaluation of Lateral Sagittal and
Costoclavicular approach for Ultrasound guided Infraclavicular Brachial
Plexus block in upper limb 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 |
Mayank Bharti |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 415, Department of Anaesthesiology, BL Taneja Block, 4th floor, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9953221174 |
| Fax |
|
| Email |
mayankbharti500@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sonia Wadhawan |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 302, Department of Anaesthesiology, BL Taneja Block, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9810946845 |
| Fax |
|
| Email |
soniawadhawan@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mayank Bharti |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room number 415, 4th floor, BL Taneja Block, Department of Anaesthesiology, Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
9953221174 |
| Fax |
|
| Email |
mayankbharti500@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, JLN Marg, New Delhi, 110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated hospitals |
| Address |
JLN Marg, New Delhi, 110002 |
| Type of Sponsor |
Government 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 |
| Mayank Bharti |
Lok Nayak Hospital |
Department of Anaesthesiology, Floors 1st to 3rd, Operation Theatre Block, Lok Nayak Hospital, JLN Marg, New Delhi, 110002
Central
DELHI |
9953221174
mayankbharti500@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Costoclavicular approach |
A transverse scan will be performed below the midpoint of the clavicle and over
the infraclavicular fossa. The transducer probe will also be tilted slightly cephalad to direct
the ultrasound beam toward the costoclavicular space. The ultrasound image will be
optimized until the 3 cords of the brachial plexus are visualized lateral to the axillary artery.
Block will be performed under local anaesthetic infiltration (1–2 mL of lignocaine 2%). The
Tuohy needle will be inserted in-plane and from a lateral-to-medial direction. The following
sonographic criteria will be used to confirm correct needle tip position: (a) visualization of the
needle tip at the centre of the cord (nerve) cluster within the CCS and (b) spread of a test
bolus injection of 1 to 2 mL of 0.9% normal saline at the centre of the cord (nerve) cluster.
Thereafter, 10ml of 2% Lignocaine + 15 ml of 0.5% bupivacaine will be slowly injected at a
single site, without any needle redirection. A catheter will be inserted after the injection. The
time taken to perform the block would be recorded. |
| Intervention |
Lateral Sagittal approach |
A sagittal scan will be performed medial to the coracoid process to obtain a
transverse view of the second part of axillary artery. The ultrasound image will be optimized,
and an effort will be made to visualize all 3 cords of the brachial plexus. The drug will be
prepared by combining 10ml of 2% Lignocaine and 15ml of 0.5% Bupivacaine. The skin
cephalad to the ultrasound transducer will be infiltrated with 1 to 2 mL of lignocaine 2%, after
which the block needle will be inserted in-plane and advanced toward the posterior aspect of
the axillary artery. After negative aspiration for blood, a test bolus injection of 1 to 2mL of
0.9% normal saline will be initially injected to confirm correct needle tip position. Thereafter,
10ml of the drug will be injected around the posterior and medial cords. The block needle will
then gradually be withdrawn until its tip is located near the lateral cord, where 15ml of drug
13
will be injected. A catheter will be inserted after the injection. The time taken to perform the
block would be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Adults 18 -65 years old, American Society of Anaesthesiology (ASA) physical health status
I-III, who are posted for forearm, elbow and hand surgery under infraclavicular brachial
plexus block. |
|
| ExclusionCriteria |
| Details |
1.Contraindications to nerve blocks like coagulopathies and local site pathology
2.History of brachial plexus injury
3.Inability to understand Verbal Rating Scale (VRS)
4.Any allergy to study medications
5.Patient refusal |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate & compare the time required for readiness to surgery after
administration of infraclavicular brachial plexus block using the Costoclavicular & Lateral
Sagittal approach. Time for readiness to surgery is defined as the time it takes to achieve a
sensory score of 30 or less(VRS) & motor grade of 1 or less in all the 4 nerves tested. |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The time taken to perform the block. |
12 months |
| The success of catheter placement. |
12 months |
| The haemodynamic parameters intraoperatively. |
12 months |
| The time to first rescue analgesia. |
12 months |
| Total amount of rescue analgesic given in first 24 hours. |
12 months |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 1 |
|
Date of First Enrollment (India)
|
04/08/2023 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Infraclavicular brachial plexus block provides anaesthesia for elbow, forearm and hand surgery. We will be comparing 2 approaches for this block - Lateral Sagittal and Costoclavicular. In the lateral sagittal infraclavicular brachial plexus block, the local
anaesthetic is injected deep to the pectoral muscles and close to the second part of the axillary artery. The costoclavicular brachial plexus block (CCB) is given in the costoclavicular space (CCS),which is an anatomical space lying behind and deep to the midpoint of the clavicle and between the subclavius and serratus anterior muscle overlying the second rib. The primary objective of the study is to evaluate the two groups with respect to the time required for readiness to surgery after administration of block. The secondary objectives include time taken to perform the block, success of catheter placement, intraoperative haemodynamic parameters, time to first rescue analgesia, the total amount of rescue analgesic given in first 24 hours and the complications, if any.
|