| CTRI Number |
CTRI/2024/01/061274 [Registered on: 09/01/2024] Trial Registered Prospectively |
| Last Modified On: |
27/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of different local anaesthetics on ultrasound guided regional block(costoclavicular) for upper limb surgery |
|
Scientific Title of Study
|
evaluation of block dynamics of ultrasound guided costoclavicular block with different local anesthetics -A prospective randomized single blind clinical study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Jeyadharani |
| Designation |
post graduate |
| Affiliation |
sri muthukumaran medical college hospital and research institute |
| Address |
post graduate anesthesia department sri muthukumaran medical college hospital and research institute chikkarayapuram near mangadu chennai
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
8778639163 |
| Fax |
|
| Email |
jeyadharanikrishnan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Navya C N |
| Designation |
Proffessor |
| Affiliation |
sri muthukumaran medical college hospital and research institute |
| Address |
anesthesia department
sri muthukumaran medical college hospital and research institute
chikkarayapuram
kanchipuram
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
9585024046 |
| Fax |
|
| Email |
drcn.navya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Jeyadharani |
| Designation |
post graduate |
| Affiliation |
sri muthukumaran medical college hospital and research institute |
| Address |
post graduate anesthesia department sri muthukumaran medical college hospital and research institute chikkarayapuram near mangadu chennai
Kancheepuram
TAMIL NADU
600069
India |
| Phone |
8778639163 |
| Fax |
|
| Email |
jeyadharanikrishnan@gmail.com |
|
|
Source of Monetary or Material Support
|
| sri muthukumaran medical college hospital and research institute |
|
|
Primary Sponsor
|
| Name |
Jeyadharani K |
| Address |
anaesthesia department
sri muthukumaran medical college hospital and research institute
chikkarayapuram
kanchipuram |
| Type of Sponsor |
Other [self] |
|
|
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 |
| jeyadharani |
sri muthukumaran medical college hospital and research institute |
5 th floor ,Operation theatre complex ,Department of Anaesthesiology
Kancheepuram
TAMIL NADU |
8778639163
jeyadharanikrishnan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUITIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S52||Fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP B(BUPIVACAINE+LIGNOCAINE ADRENALINE) |
ADMINISTRATION OF 0.5%BUPIVACAINE +2%LIGNOCAINE ADRENALINE IN COSTOCLAVICULAR BLOCK |
| Comparator Agent |
GROUP R(ROPIVACAINE) |
Details of Group R 0.325%ROPIVACAINE CONSTITUTED BY DILUTING 0.75%ROPIVACAINE AT 1:1 RATIO WITH DISTILLED WATER+1ML OF DEXAMETHASONE
VOLUME NOT EXCEEDING 30 ML |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ADULT PATIENT OF ASA PHYSICAL STATUS 1 & 2 OF ALL GENDERS , AGED BETWEEN 18-65 YEARS OF AGE POSTED FOR UPPER LIMB SURGERIES BELOW MID ARM LEVEL |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL
PATIENT WITH KNOWN HYPERSENSITIVITY OR CONTRAINDICATIONS TO TGHE STUDY DRUGS
LOCAL INFECTION AT THE SITE OF BLOCK
PATIENTS WITH ADVANCED RENAL , CARDIAC ,HEPATIC & RESPIRATORY DISEASES
PATIENTS WITH SEVERE COAGULOPATHY & ON ANTIPLATELET DRUGS
PREGNANT PATIENTS
PATIENTS WITH NEUROLOGICAL DEFICITS ,PSYCHIATRIC ILLNESS,NEUROVASCULAR DISORDERS & SUBSTANCE ABUSE
PATIENTS WITH BMI>30
PARTIAL & FAILED BLOCKS WILL BE EXCLUDED FROM THE STUDY |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the onset time with respect to sensory and motor onset . with composite score of 14/16 |
0,5 ,10, 15 ,20,25 & 30 minutes after block needle removal . |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare duration of motor block
Verbal numerical rating score [VNRS]
To compare duration of sensory block
Time for first request of analgesic
Need for rescue analgesic
Total consumption of opioids at 48 hours |
AT 6,12,18 ,24 ,48 HOURS AFTER BLOCK NEEDLE REMOVAL
AND TOTAL OPIOID CONSUMPTION AT 48 HOURS |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
13/01/2024 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response - Proposals should be directed to [jeyadharanikrishnan@gmail.com].
- For how long will this data be available start date provided 01-05-2026 and end date provided 01-05-2031?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
brachial plexus block provides anaesthesia upper limb surgery ,out of which infraclavicular costoclavicular approach has become convenient & safe method to block all three cords at single site {because they share consistent relationship with each other at this space clustered together lateral to axillary artery ). onset time is one of the important consideration for choosing local anaesthetics , to hasten block onset higher concentrations of LA were used ,however diluted LA are safer . ropivacaine has shown to have earlier onset than bupivacaine at equipotent doses , but it is expensive .To hasten onset of bupivacaine lignocaine with adrenaline is added there are no studies comparing the above mentioned drug onset time , hence we compare the onset time of bupivacaine and ropivacaine in ultrasound guided costoclavicular block for unilateral upper limb surgeries below mid arm level |