| CTRI Number |
CTRI/2024/08/072782 [Registered on: 20/08/2024] Trial Registered Prospectively |
| Last Modified On: |
19/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Two Types of Nerve Blocks for Forearm Surgeries using Ultrasound |
|
Scientific Title of Study
|
Comparison of Ultrasound Guided Triple Injection Costoclavicular Block with Lateral Approach of Axillary Brachial Plexus Block in Below-Elbow Surgeries
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1311-5056 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr. Abishek Jain |
| Designation |
Junior Resident (MD ANAESTHESIA) |
| Affiliation |
TMU MEDICAL COLLEGE AND HOSPITAL MORADABAD |
| Address |
Room No. 204 Department of Anaesthesia Teerthanker Mahaveer Medical College and Research Centre N.H.-24,Delhi Road,Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9417728616 |
| Fax |
|
| Email |
drabishekjain@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Payal Jain |
| Designation |
Associate Professor |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre,Moradabad,Uttar Pradesh |
| Address |
Room No. 204 Department of Anaesthesia Teerthanker Mahaveer Medical College and Research Centre N.H.-24,Delhi Road,Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9855567933 |
| Fax |
|
| Email |
payalravi1408@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mukesh Kumar Prasad |
| Designation |
Professor and HOD |
| Affiliation |
Teerthanker Mahaveer Medical College and Research Centre,Moradabad,Uttar Pradesh |
| Address |
Room No. 204 Department of Anaesthesia Teerthanker Mahaveer Medical College and Research Centre N.H.-24,Delhi Road,Moradabad
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
9837624543 |
| Fax |
|
| Email |
mukeshkumar2002@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthanker Mahaveer Medical College, Moradabad, Uttar Pradesh-India-244001 |
|
|
Primary Sponsor
|
| Name |
Teerthanker Mahaveer Medical College and Research Centre |
| Address |
Teerthanker Mahaveer Medical College and Research Centre,
N.H.-24, Delhi Road, Moradabad-244001, Uttar Pradesh |
| 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 ABISHEK JAIN |
Teerthanker Mahaveer Medical College and Research Centre |
Room No 204,
Department of Anaesthesia,Moradabad, Uttar
Pradesh
Moradabad
UTTAR PRADESH |
9417728616
drabishekjain@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee,TMU University,Moradabad,UP |
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 |
| Intervention |
USG guided Costoclavicular Block |
Group CC will receive ultrasound guided Costoclavicular block will be performed with a 10â€cm, 21â€gauge nerve block needle and 20ml 0.5% ropivacaine(dose-3mg/kg) will be injected through intraneural route.The time immediately after LA injection will be considered as time 0 for sensory and motor assessment. Every 5,10,15,20,25,30 min after block performance, assessed the sensory and motor block of Radial, Medial, Ulnar and Musculocutaneous nerve using Lovett score and duration will be 30 mins. |
| Comparator Agent |
USG guided Lateral Approach Axillary Block |
Group AX will receive ultrasound guided Axillary block will be performed with a 10â€cm, 21â€gauge nerve block needle and 20ml 0.5% ropivacaine (dose-3mg/kg) will be injected through intraneural route.The time immediately after LA injection will be considered as time 0 for sensory and motor assessment. Every 5,10,15,20,25,30 min after block performance, assessed the sensory and motor block of Radial, Medial, Ulnar and Musculocutaneous nerve using Lovett score and duration will be 30 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient giving written and informed consent.
American Society of Anesthesiologist (ASA) physical status I-II.
Age group of 18-60 years old.
Elective below elbow surgery.
BMI 18.5-22.9kg/m2.
|
|
| ExclusionCriteria |
| Details |
Patients with coagulopathy
Pre-existing neurological deficit
Local infection.
Known allergic to local anesthesia.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the Sensory Motor Score for individual nerves in both the groups (Radial,Ulnar,Median,Musculocutaneous nerve).
To compare duration of post operative analgesia in both the groups.
|
The time immediately after LA injection will be considered as time 0mins for sensory and motor assessment. Every 5,10,15,20,25,30 min after block performance, assessed the sensory and motor block of Radial, Medial, Ulnar and Musculocutaneous nerve using Lovett score and duration will be 30 mins.
Post operative analgesia will be assessed in both groups after 1hr.2hr.3hr.4hr.5hr and then every 6th hourly.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare composite sensory motor block in both the groups.
To compare onset time in both the groups.
To compare No. of needle redirections in both the groups.
To compare No. of needle attempts in both the groups.
To compare performance time in both the group.
|
Intraoperative assessment of composite block at 0min, 5min,10min,15min,20min,25min,30min
Onset time assessment in both groups after block given at 0min, 5min,10min,15min,20min,25min,30min.
No of needle redirection in both groups at 0min, 5min,10min,15min,20min,25min,30min till the block provided.
No of needle attempts in both groups at 0min, 5min,10min,15min,20min,25min,30min till the block given.
Intraoperative assessment of performance time at 0min, 5min,10min,15min,20min,25min,30min
|
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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 4 |
|
Date of First Enrollment (India)
|
02/09/2024 |
| 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="3"
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
|
After getting approval from Institutional Ethical Committee (IEC),those patients who are fit in inclusion criteria will be included in our study and After taking Written informed consent.
Randomization will be done and 80 Patients will be assigned into two groups Group CC and group AX.
Group CC (40,Costoclavicular approach) : 20â€mL 0.5% Ropivacaine. Group AX (40,Axillary approach) : 20â€mL 0.5% Ropivacaine.
Patient will be shifted to Operating Room and after following the standard protocol under strict aseptic precautions, ultrasound guided block will be performed with a 10â€cm, 21â€gauge nerve block needle and fixed dose of drug will be given.
The duration of procedure, Time of onset of sensory and motor block, duration of sensory and motor block, number of needle redirections and needle attempts will be noted.
The BPB will be considered incomplete if the composite score will be more than 16 points even after 30 min with sensory Grade - 0.In the event of an incomplete block after 30 min, a rescue block or local infiltration will be given and will be recorded as block failure . Any complications of the block procedure such as hematoma, pneumothorax, and LA toxicity will be noted. Post operative sensory and motor block will be assessed at 1,2,4,6,8 hours
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