CTRI Number |
CTRI/2011/07/001876 [Registered on: 12/07/2011] Trial Registered Retrospectively |
Last Modified On: |
18/11/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
A clinical trial to study the effects of two types of needles to perform above clavicle nerve block for doing forearm and hand surgeries |
Scientific Title of Study
|
To determine efficacy of supraclavicular brachial plexus block using blunt versus short bevel needle: a prospective randomized double blind 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 |
Dr Vanita Ahuja |
Designation |
Assistant Professor |
Affiliation |
Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 |
Address |
Dr Vanita Ahuja
Assistant Professor
Department of Anaesthesia and Intensive Care
Government Medical College and Hospital Sector 32 Chandigarh
Chandigarh CHANDIGARH 160032 India |
Phone |
9815496989 |
Fax |
|
Email |
vanitaanupam@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
Name |
Dr Vanita Ahuja |
Designation |
Assistant Professor |
Affiliation |
Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 |
Address |
Dr Vanita Ahuja
Assistant Professor
Department of Anaesthesia and Intensive Care
Government Medical College and Hospital Sector 32 Chandigarh
CHANDIGARH 160032 India |
Phone |
9815496989 |
Fax |
|
Email |
vanitaanupam@yahoo.co.in |
|
Details of Contact Person Public Query
|
Name |
Dr Vanita Ahuja |
Designation |
Assistant Professor |
Affiliation |
Department of Anaesthesia and Intensive Care Government Medical College and Hospital Sector 32 |
Address |
Dr Vanita Ahuja
Assistant Professor
Department of Anaesthesia and Intensive Care
Government Medical College and Hospital Sector 32 Chandigarh
CHANDIGARH 160032 India |
Phone |
9815496989 |
Fax |
|
Email |
vanitaanupam@yahoo.co.in |
|
Source of Monetary or Material Support
|
Government Medical College and Hospital Sector 32 Chandigarh |
|
Primary Sponsor
|
Name |
Dr Vanita Ahuja |
Address |
Assistant Professor
Department of Anaesthesia and Intensive Care
Government Medical College and Hospital Sector 32 Chandigarh
|
Type of Sponsor |
Government 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 Vanita Ahuja |
Department of Anaesthesia and Intensive Care |
Government Medical College and Hospital Sector 32 Chandigarh Chandigarh CHANDIGARH |
09646121649
vanitaanupam@yahoo.co.in |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Ethics Committee Government Medical College and Hospital Sector 32 Chandigarh |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: S424||Fracture of lower end of humerus, Onset and efficacy of regional anaesthesia; supraclavicular nerve block
, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
Supraclavicular brachial plexus block under ultrasound guidance using 20 G short bevel needle |
The block effect will be assessed by an independent observer every 5 minutes in individual nerve territories both motor and sensory till the attainment of block or to a maximum of 60 minutes |
Comparator Agent |
Supraclavicular brachial plexus block under ultrasound guidance using 20 G Touhy needle |
The block effect will be assessed by an independent observer every 5 minutes in individual nerve territories both motor and sensory till the attainment of block or to a maximum of 60 minutes |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
American society of anesthesiologist (ASA) I–II
below elbow surgeries
|
|
ExclusionCriteria |
Details |
patient refusal
known neuropathy involving the arm undergoing surgery
mental incapacity
body mass index more than 35 kg/m2
known allergy to local anesthetics
local infection
coagulopathy
fasting less than 8 hours
any other contraindication to peripheral nerve blocks
|
|
Method of Generating Random Sequence
|
Random Number Table |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Primary aim of this study will be to determine the efficacy of individual nerve blocks using blunt versus short bevel needle under ultrasound guidance for placement of supraclavicular brachial block for below elbow surgeries. Assuming that establishment of sensory and motor block occurs in 30 minutes and show a difference of 5.0 minutes will be significant for successful surgical block.
|
02 years |
|
Secondary Outcome
|
Outcome |
TimePoints |
Block performance time, procedure related pain, ideal block evaluation time, nerve block supplementation and early neurological sequel |
02 years |
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
Phase of Trial
|
Phase 4 |
Date of First Enrollment (India)
|
06/06/2011 |
Date of Study Completion (India) |
Date Missing |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
Supraclavicular brachial plexus block is being routinely performed under ultrasound guidance for below elbow surgeries .It has many advantages as it allows the operator to visualize the needle and surrounding structures, minimizes the risk of contact with the pleural dome, and subclavian artery, decrease procedural times and increases block success .This study is a prospective ,randomized, double blind, single-centre trail to determine efficacy of supraclavicular brachial plexus block using blunt versus short bevel needle. A written informed consent from 60 patients American society of anesthesiologist (ASA) I�II, between 18 -60 years, of either sex, undergoing below elbow surgery will taken up for the clinical trial. The primary outcome measures will be efficacy of individual nerve blocks using blunt versus short bevel needle for supraclavicular block. The block effect will be assessed by an independent observer every 5 minutes in individual nerve territories both motor and sensory till the attainment of block or to a maximum of 60 minutes. Secondary outcome will be block performance time, procedure related pain, ideal block evaluation time, nerve block supplementation and early neurological sequel. |