| CTRI Number |
CTRI/2024/05/067845 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
22/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Ultrasound guided infraclavicular brachial plexus block with 2 different approaches |
|
Scientific Title of Study
|
An observational study of ultrasound guided infraclavicular brachial plexus block with Costoclavicular and Retroclavicular approaches for upperlimb orthopedic surgeries |
| 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 Dhrumi Sutariya |
| Designation |
2nd year Anesthesia resident |
| Affiliation |
New civil hospital surat |
| Address |
2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat
GUJARAT
395001
India
Surat GUJARAT 395001 India |
| Phone |
9726809725 |
| Fax |
|
| Email |
ddsutariya9725@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Bansari N Kantharia |
| Designation |
Additional professor |
| Affiliation |
New surat civil hospital Surat |
| Address |
2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat
GUJARAT
Surat GUJARAT 395001 India |
| Phone |
9825690177 |
| Fax |
|
| Email |
bansarikantharia@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bansari N Kantharia |
| Designation |
Additional professor |
| Affiliation |
New surat civil hospital Surat |
| Address |
2nd Floor, Old college building, Department of Anesthesia, Government Medical college-Surat, near Majura gate Surat
GUJARAT
Surat GUJARAT 395001 India |
| Phone |
9825690177 |
| Fax |
|
| Email |
bansarikantharia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college and new civil hospital surat, Gujarat, India
Pincode- 395001 |
|
|
Primary Sponsor
|
| Name |
Government medical college and new civil hospital Surat |
| Address |
New civil Hospital, near Majura gate, Surat, pincode- 395001 , Gujarat, India |
| 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 Dhrumi Sutariya |
Government medical College and new civil hospital surat |
First floor Orthopaedic operation theatre in OT building Surat GUJARAT |
9726809725
ddsutariya9725@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Research Ethics Committee, Government Medical College, Majuragate , surat |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Infraclavicular brachial plexus block |
Patients posted for upper limb orthopaedic surgery and fulfilling my inclusion criteria Usg guided Infraclavicular brachial plexus block will be given by retroclavicular approach or Costcoclavicular approach as a mode of Anaestheasia . Infraclavicular brachial plexus block will be given using insulated block needle using a combination of;
-Inj. Bupivacaine(0.5%) 20 ml ,Inj. Lignocaine (2%) 10 ml,
Inj. Dexamethasone 2 ml. Total 32 ml volume will be given.I will observe the block performance time ,quality of block, will observe the Duration of motor and sensory block for 24 hours . Will note the analgesic requirements for 24 hours after block is given. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients who will undergo planned upper limb surgeries under usg guided Infraclavicular brachial plexus block with Costoclavicular and Retroclavicular approaches and giving written informed consent.
2. Patients belonging to ASA class 1, 2,3 .
3.Patients of either sex, in the age group of 18 to 65yrs. |
|
| ExclusionCriteria |
| Details |
1. Patients with known hypersensitivity to local anaesthetics.
2. Infection at the site of block . 3. Morbidly obese patient.
4.Patients with neurological, psychiatric or neurovascular disorders.
5.Patients with major cardio-pulmonary or hepato renal compromise.
6. Pregnant patients. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1) Block performance time.
2) Block characteristics- onset and duration of sensory and motor block
3)Quality of block. |
1) Block performance time will be assessed from time of needle insertion to time of injecting drug
2) Block characteristics- onset and duration of sensory and motor block for 24 hours
3)Quality of block. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Duration of post operative analgesia and requirement of analgesics in 24 hours.
2)Intraoperative Hemodynamic changes.
3)Complications/Adverse events if any |
Till 24 hours after giving block |
|
|
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 3 |
|
Date of First Enrollment (India)
|
02/06/2024 |
| 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="3" 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 - NO
|
|
Brief Summary
|
Most upper limb surgeries are done under brachial plexus block as it provides anesthesia along with postoperative analgesia without any need of airway manipulation. According to site of injury and other factors Brachial plexus block is given through various approaches like Interscalene block, Supraclavicular, Infraclavicular or Axillary .Infraclavicular block provides excellent anesthesia for upper limb surgeries. The infraclavicular brachial plexus has easily recognisable sonoanatomy, a high success rate, and low risk of pnemothorax. Identification of the axillary artery is the key landmark in performing this block.The use of ultrasound (USG) adds valuable information such as visualisation of the needle tip and real-time observation of the injectate surrounding the nerves. Use of USG also reduces the risk of adverse events such as inadvertent intravascular injection and trauma to surrounding structures. In the costoclavicular approach, the ultrasound transducer is placed parallel to and below the clavicle. In this view, the cords are clustered together, at a more superficial level,the cords could be blocked more rapidly with the CC approach and that the block is administered faster and requires a fewer number of needle redirections. There is no increased incidence of pneumothorax with the CC approach. The Retroclavicular approach consists of inserting the needle in the supraclavicular fossa, behind the clavicle, in-plane in a paramedian sagittal plane cephalo-caudad direction until the needle tip is positioned behind the axillary artery with the US probe resting in the delto-pectoral groove.The point of needle insertion, however, is over the trapezius muscle posteriorly. This approach allows the needle to pass between the scapula and the clavicle toward the axillary artery in the infraclavicular area. These two techniques are simple, reliable ,safe and effective.In our institute so far no study evaluating the characteristics of these two techniques is done. Hence, we are planning to do this study.
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