| CTRI Number |
CTRI/2025/03/083505 [Registered on: 26/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparing sequential drug delivery for nerve block between one dug and two drugs |
|
Scientific Title of Study
|
Sequential Administration Of Dual Or Single Injection Of Local Anaesthetic For Continuous Infraclavicular Block-Does It Make A Difference?-A Randomized Controlled 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 |
Kousalya G |
| Designation |
Post doctoral fellowship |
| Affiliation |
Christian Medical College,Vellore |
| Address |
Department of Anaesthesia,
Christian Medical College
Vellore TAMIL NADU 632004 India |
| Phone |
8124320960 |
| Fax |
|
| Email |
gkousalya53@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Serina ruth salins |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Professor and Head of Unit-II,
Department of Anaesthesia,
Christian Medical College
Vellore TAMIL NADU 632004 India |
| Phone |
9442307738 |
| Fax |
|
| Email |
serina.ruth@cmcvellore.ac.in |
|
Details of Contact Person Public Query
|
| Name |
Serina ruth salins |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Professor and Head of Unit-II,
Department of Anaesthesia,
Christian Medical College
Vellore TAMIL NADU 632004 India |
| Phone |
9442307738 |
| Fax |
|
| Email |
serina.ruth@cmcvellore.ac.in |
|
|
Source of Monetary or Material Support
|
| Christian medical college,
Vellore-632004,
Tamilnadu,
India. |
|
|
Primary Sponsor
|
| Name |
Christian medical college |
| Address |
Christian medical college,
Vellore-632004
Tamilnadu,
India. |
| 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 Kousalya G |
Christian medical college |
Department of Anaesthesia,
7th floor,
New paul brand building,
Christian medical college,
Vellore-632004,
India. Vellore TAMIL NADU |
8124320960
gkousalya53@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional review board, Office of research, Christian medical college, Vellore, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
comparing sequential administration of ropivacaine alone with lignocaine and ropivacaine for nerve block |
comparing sequential administration of 10ml 0.5% ropivacaine and 10 ml 0.5% ropivacaine with 10ml 1% lignocaine and 10 ml 0.5% ropivacine for infraclavicular nerve block using peripheral nerve block needle with single injection and assess the onset and duration of sensory and motor blockade.onset of sensory blockade and motor blockade is assessed in minutes until complete loss of sensory and motor blockade occurs duration of sensory and motor blockade is assessed every 2 hours till 24 hours and every 4 hours till 24 hours
|
| Intervention |
comparing sequential administration of ropivacaine alone with lignocaine and ropivacaine for nerve block |
For continuous infraclavicular nerve block sequential administration of local anaesthetic is done
Group A receives 0.5% ropivacaine 10 ml followed by a 20 seconds pause another 0.5% ropivacaine 10 ml is given using peripheral nerve block needle with single injection
Group B receives 1% lignocaine 10ml followed by a 20 seconds pause 0.5% ropivacaine 10ml is given
The total duration of procedure can take 15 minutes
Assessment of onset of sensory and motor blockade and duration of block, complications.
onset of sensory blockade and motor blockade is assessed in minutes until complete loss of sensory and motor blockade occurs
duration of sensory and motor blockade is assessed every 2 hours till 24 hours and every 4 hours till 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Patients with ASA I, II, III undergoing elective below-elbow and hand surgery
aged between 18-75years
Either sex
|
|
| ExclusionCriteria |
| Details |
patient with significant neurological, psychiatric, or neuromuscular disease
suspected coagulopathy
morbid obesity
chronic renal failure
cardiopulmonary compromise
cerebral vascular disease
local infection at the site of the infraclavicular block
pregnant women and children |
|
|
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 |
onset of sensory blockade
onset of motor blockade
duration of sensory blockade
duration of motor blockade |
sensory onset is assessed in minutes every 30 seconds until achieved
motor onset is assessed in minutes every 5 minutes until achieved
duration of sensory and motor blockade is assessed every 2 hours till 12 hours and every 4 hours till 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| intraoperative use of analgesics & complications |
baseline |
|
|
Target Sample Size
|
Total Sample Size="174" Sample Size from India="174"
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 3 |
|
Date of First Enrollment (India)
|
01/04/2025 |
| 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
|
Local anaesthetic drugs are classified according to the duration of action as short, intermediate and long-acting drugs. Combining different classes of local anaesthetic drugs for peripheral nerve blocks has faster onset and prolonged duration of action. The purpose of this double blinded randomized controlled study is to compare onset and duration of action between sequential administration of one drug and a mixture of two different drugs , in terms of onset and duration, however, the same pharmacological groups of local anaesthetic drugs, for ultrasound guided infraclavicular approach with to brachial plexus block. An infraclavicular approach to the brachial plexus block can be used for surgical procedures below the mid humerus. It has gained popularity because of its ease of performance and the ability to simultaneously anaesthetize the axillary, musculocutaneous, median, radial and ulnar nerves. The block can be done with minimal risk of pneumothorax and other complications such as block of the phrenic nerve or stellate ganglion. An infraclavicular approach to brachial plexus block provides sufficient anaesthetic and analgesic effect for below-elbow and hand surgeries. Infraclavicular approach is not only advantageous for inserting a perineural catheter, but also has a short procedure time compared to other approaches including supraclavicular and axillary approaches especially using ultrasound guidance Group A- will receive 10ml 0.5% Ropivacine+10 ml 0.5% Ropivacaine Group B- will receive 10ml 1% Lignocaine+10 ml 0.5% Ropivacaine Post procedure the onset of block is assessed by recording the sensory and motor blockade by time to complete loss of sensation and complete loss of motor power, need for intraoperative surgical anaesthesia and analgesia, is recorded and duration of block is assessed by time to rescue analgesia. |