| CTRI Number |
CTRI/2021/07/035024 [Registered on: 20/07/2021] Trial Registered Prospectively |
| Last Modified On: |
15/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of the effects of three different volumes and concentration a Local Anaesthesia in Ultrasound Guided Supraclavicular block |
|
Scientific Title of Study
|
Comparative study of the effects of three different volumes and concentrations of levobupivacaine on the block characteristics in upper limb surgeries using ultrasound guided supraclavicular block - randomized control study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Aruna Manaswini |
| Designation |
Post Graduate |
| Affiliation |
Chettinad Hospital Research Institute Kanchipuram |
| Address |
Department of Anaesthesiology
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
08925613936 |
| Fax |
|
| Email |
arunamanaswini1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
S Anand |
| Designation |
Professor |
| Affiliation |
Chettinad Hospital Research Institute Kanchipuram |
| Address |
Department of Anaesthesiology
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9444486183 |
| Fax |
|
| Email |
dranandmurugan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
M Aruna Manaswini |
| Designation |
Post Graduate |
| Affiliation |
Chettinad Hospital Research Institute Kanchipuram |
| Address |
Department of Anaesthesiology
Chettinad Hospital and Research Institute
Rajiv Gandhi Salai
Kelambakkam
Kancheepuram
TAMIL NADU
603103
India |
| Phone |
9943587332 |
| Fax |
|
| Email |
arunamanaswini1@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr M Aruna Manaswini
Post Graduate
Department of Anaesthesiology
Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, Kelambakkam Tamil Nadu 603103 |
|
|
Primary Sponsor
|
| Name |
M Aruna Manaswini |
| Address |
Post Graduate
Department of Anaesthesiology
Chettinad Hospital and Research Institute, Rajiv Gandhi Salai, Kelambakkam Tamil Nadu 603103 |
| Type of Sponsor |
Other [M Aruna Manaswini] |
|
|
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 |
| M Aruna Manaswini |
Chettinad Hospital and Research Institute |
Department of Anaesthesiology
1st floor Operation Theatre Complex
Chettinad Health City
Rajiv Gandhi Salai, Kelambakkam 603103
Kancheepuram
TAMIL NADU |
8925613936
arunamanaswini1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: V00-Y99||External causes of morbidity, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided Supraclavicular Block |
Ultrasound guided Supraclavicular block using 15mL of Levobupivacaine for patients undergoing upper arm surgeries |
| Comparator Agent |
Ultrasound guided Supraclavicular block |
Ultrasound guided supraclavicular block using 20mL of Levobupivacaine in patients undergoing upper arm surgeries |
| Comparator Agent |
Ultrasound guided supraclavicular block |
Ultrasound guided supraclavicular block using 30mL of Levobupivacaine for patients undergoing upper arm surgeries |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American Society of Anaesthesiologists (ASA) Physical Status of Grade – I, Grade –II and Grade III
2. Age between 18 - 60 years.
3. Patients undergoing upper arm orthopedic and general surgery.
|
|
| ExclusionCriteria |
| Details |
1. Severe Bronchopulmonary disease
2. Neurologic or neuromuscular disease
3. Coagulation disorders
4. Infection at the site of injection
5. Known allergy to the drug used
6. Body mass index more than 30kg/m2.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the block Characteristics like Onset of Sensory blockade, Onset of motor blockade and Duration of analgesia of three different volumes 15mL, 20mL and 30mL of Levobupivacine using ultrasound guided supraclavicular block. |
1. Onset of Sensory Blockade: The time at which loss of cold temperature perception radial, ulnar, median and musculocutaneous dermatomes.
2. Onset of Motor Blockade: the time at which the appearance of loss of complete motor activity in the areas supplied by radial, median, ulnar and usculocutaneous nerves.
For Duration of Analgesia: Time at which patient first requests rescue analgesia post operatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the incidence of diaphragmatic involvement and side effects of three different volumes 15mL, 20mL and 30mL in ultrasound guided supraclavicular block. |
1. For Diaphragmatic involvement:
Baseline - Before the administration of the block
For Diaphragmatic involvement assessment - 10 minutes Post administration of the
2. For side effects: till the duration of surgery |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/08/2021 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Compare the effects of the block characteristics such as Onset of sensory blockade, Onset of motor blockade, Duration of analgesia, Incidence of Diaphragmatic involvement and side effects of three different volumes (15mL, 20mL and 30mL) of Levobupivacaine using Ultrasound guided Supraclavicular block. |