CTRI Number |
CTRI/2023/10/058720 [Registered on: 16/10/2023] Trial Registered Prospectively |
Last Modified On: |
16/10/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of two approaches of continuous brachial plexus block among children undergoing elbow, forearm and hand surgeries. |
Scientific Title of Study
|
Comparison of analgesic efficacy and safety of Ultrasound guided infraclavicular brachial plexus blockade to a modified continuous costoclavicular block (Caudocranial RetroAxillary interFascial Transpectoral- CRAFT approach) in pediatric patients undergoing upper limb surgeries -A Randomized control trial. |
Trial Acronym |
NIL |
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
VIMAL B |
Designation |
PG REGISTRAR |
Affiliation |
CMC VELLORE |
Address |
DEPARTMENT OF ANAESTHESIA,
CMC HOSPITAL,THOTTAPALYAM,
VELLORE - 632004 DEPARTMENT OF ANAESTHESIA,
CMC HOSPITAL,THOTTAPALYAM,
VELLORE - 632004
Vellore TAMIL NADU 632004 India |
Phone |
7708013450 |
Fax |
|
Email |
vimale101@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
SAJAN P GEORGE |
Designation |
PROFESSOR |
Affiliation |
CMC VELLORE |
Address |
DEPARTMENT OF ANAESTHESIA,
CMC VELLORE - 632004 DEPARTMENT OF ANAESTHESIOLOGY
CMC VELLORE
Vellore TAMIL NADU 632004 India |
Phone |
04162282105 |
Fax |
|
Email |
sajanpg@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
Name |
Vimal B |
Designation |
PG Registrar |
Affiliation |
CMC Vellore |
Address |
Department of Anaesthesiology
CMC Vellore - 632004 Department of Anaesthesiology
CMC Vellore - 632004 Vellore TAMIL NADU 632004 India |
Phone |
7708013450 |
Fax |
|
Email |
vimale101@gmail.com |
|
Source of Monetary or Material Support
|
CMC VELLORE FLUID RESEARCH FUND,
Vice Principal for Research,
Research Office, 1st floor - Carman Block
CMC Bagayam Campus,
Vellore - 632002 |
|
Primary Sponsor
|
Name |
CMC Vellore Hospital and College |
Address |
Research office, 1st Floor - Carman Block,
CMC Vellore College, Bagayam ,
Vellore-632002 |
Type of Sponsor |
Research institution and hospital |
|
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 |
VIMAL B |
CMC Hospital VEllore |
OR Rooms - Paul Brand Building, Department of Anaesthesia,
CMC Hospital, Vellore - 632004 Vellore TAMIL NADU |
04162282105
vimale101@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
CMC VELLORE SILVER IRB |
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 |
Conventional continuous catheter technique for the infraclavicular brachial plexus block |
Conventional continuous catheter technique for the infraclavicular brachial plexus block |
Intervention |
Modified continuous costoclavicular block (caudocranial transpectoral approach) |
Modified continuous costoclavicular block (caudocranial transpectoral approach) |
|
Inclusion Criteria
|
Age From |
6.00 Month(s) |
Age To |
7.00 Year(s) |
Gender |
Both |
Details |
Inclusion criteria:
1) Children aged 6 months-7years undergoing elbow, forearm, and hand surgeries.
2) ASA 1 and ASA 2 Patients.
|
|
ExclusionCriteria |
Details |
Exclusion criteria:
1) Patients with severe systemic illness.
2) Patients with local infection at the injection site, bleeding diathesis.
3) Patients with known allergic reactions to local anesthetics. |
|
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 |
Equal efficacy of post operative analgesia using the newer approach as measured by FLACC scores |
Equal efficacy of post operative analgesia using the newer approach as measured by FLACC scores |
|
Secondary Outcome
|
Outcome |
TimePoints |
1) Safety – significant reduction in risk of inadvertent neurovascular injury.
2) Better catheter stability & tolerance.
3) Usage of minimal drug volumes.
|
6,24, 48 HOURS |
|
Target Sample Size
|
Total Sample Size="54" Sample Size from India="54"
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 2 |
Date of First Enrollment (India)
|
16/10/2023 |
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="3" Days="10" |
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 is a preferred regional anaesthetic modality in elbow, forearm and
hand surgeries in pediatric patients. The conventional approach to
infraclavicular block by using ultrasound is performed in supine position with
arm abducted to 90 degrees and the needle is inserted from cranial to caudal
direction at a point 1cm below and 1cm lateral to midpoint of clavicle through
which the catheter is inserted and left insitu, the complications of these
approach are vessel puncture (2-33%), neurological injuries and pneumothorax.
This study aims at an alternative approach to the brachial plexus block which
targets the brachial plexus components at the costoclavicular level and is
equally effective. The neurovascular bundle will be approached from the
inferolateral aspect. This will be achieved by the anesthesiologist standing
facing the head end of the patient and the needle will be inserted from caudal
to cranial direction. Pediatric patients undergoing elbow and forearm surgery
will be recruited. The study participants will be randomly assigned to the
conventional or new approach and the patients will be masked about the
allocation. The random allocation will be done using sealed envelopes which
will be opened just before painting and draping the patient for nerve block.
Information on pain score in post operative period in first 6hrs, 24 and 48
hours will be measured using FLACC pain scale. Complications like neurological
injury during procedure, neurological damage at 24 and 48 hours will be
assessed. Amount and frequency of rescue analgesia administered will be
compared. Median pain scores will be compared to test equivalence between
approaches. Incidence of complications and mean duration of analgesia will be
compared using percentages and measures of central tendency respectively. |