| CTRI Number |
CTRI/2019/05/018969 [Registered on: 07/05/2019] Trial Registered Prospectively |
| Last Modified On: |
07/05/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare the effectiveness of two different types of Anaesthetic techniques, Supraclavicular and Infraclavicular Upper limb Nerve Blocks, for anaesthesia and pain relief during upper limb surgeries and to evaluate the safety of the respective techniques. |
|
Scientific Title of Study
|
A comparison between Ultrasound-guided Supraclavicular and Infraclavicular approaches to Brachial Plexus Block for elective upper limb surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
GURU AVINASH G |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam, Madagadipet,
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9442884752 |
| Fax |
|
| Email |
guru.avinash.2007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sureshkumar K |
| Designation |
Associate Professor |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam, Madagadipet,
Puducherry
Pondicherry
PONDICHERRY
605107
India |
| Phone |
9884190530 |
| Fax |
|
| Email |
surekumk9292@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
GURU AVINASH G |
| Designation |
Post Graduate Resident |
| Affiliation |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Department of Anaesthesiology,
Sri Manakula Vinayagar Medical College and Hospital,
Kalitheerthalkuppam, Madagadipet,
Puducherry
PONDICHERRY
605107
India |
| Phone |
9442884752 |
| Fax |
|
| Email |
guru.avinash.2007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Manakula Vinayagar Medical College Hospital,
Kalitheerthalkuppam, Madagadipet, Puducherry - 605107 |
|
|
Primary Sponsor
|
| Name |
Sri Manakula Vinayagar Medical College and Hospital |
| Address |
Kalitheerthalkuppam, Madagadipet,
Puducherry - 605107 |
| 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 Guru Avinash |
Sri Manakula Vinayagar Medical College Hospital |
Department of Anaesthesiology,
Sri Manakula Vinayagar Medical College Hospital,
Kalitheerthalkuppam, Madagadipet,
Puducherry - 605107
Pondicherry
PONDICHERRY |
9442884752
guru.avinash.2007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMVMCH - Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm, (2) ICD-10 Condition: S40-S49||Injuries to the shoulder and upper arm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Infraclavicular Brachial Plexus Block |
block performance time and time of onset |
| Intervention |
Supraclavicular Brachial Plexus Block |
Block performance time and Time of Onset |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
i) Age 18-60 years
ii) ASA I and II
iii) Both Genders
iv) Body Weight 45 - 85 Kg
|
|
| ExclusionCriteria |
| Details |
i) Age < 18yrs
ii) Pregnant women
iii) Infection at the site of block
iv) Patients with coagulopathy
v) H/o allergy to local anaesthetic drugs
vi) Mental incapacity or language barrier precluding to informed consent
vii) Patient refusal
viii) Pre-existing motor or sensory deficit in the operative limb
ix) Severe pulmonary pathology
|
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Block performance time |
the interval between placement of ultrasound probe to the removal of needle after injection of local anesthetic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications due to Nerve Blocks |
Pneumothorax - Immediate complication
Local Anaesthetic Systemic Toxicity - Immediate complication
Residual Neuronal Damage - Post operatively - 6 hours
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
13/05/2019 |
| 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="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The advent of
ultrasonography in Anaesthesia practice has made it a valuable adjunct in Peripheral
Nerve Blocks for Regional Anaesthesia. The apparent benefits of direct visualization
of the nerves and their surrounding anatomy, continuous observation of the needle
tip and the spread of local Anaesthetic make Ultrasound Guided Regional Anaesthesia
highly appealing to patients as well as Anaesthesiologists. Hence, we propose
that Infraclavicular approach of Brachial Plexus Block will be faster to
perform and as safe as Supraclavicular approach, with fewer complications while
using Ultrasound guidance. There are only a few studies in the literature that compare
Supraclavicular and Infraclavicular approaches of the Brachial Plexus block
using Ultrasound Guidance. |