| CTRI Number |
CTRI/2024/01/061787 [Registered on: 24/01/2024] Trial Registered Prospectively |
| Last Modified On: |
22/01/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Comparative study of ultrasound guided brachial plexus blocks with
supraclavicular and infraclavicular approaches in upper limb orthopedic surgeries to find the ease of giving and effects and find out which one is more good for patients |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF ULTRASOUND GUIDED SUPRACLAVICULAR AND INFRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB ORTHOPEDIC SURGERY |
| 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 Pooja Mathur |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College,Ajmer |
| Address |
Anaesthetic Consultant room , orthopedic operation theatre, orthopedic department,jawahar lal nehru
hospital,ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414003933 |
| Fax |
|
| Email |
drpoojarawat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pooja Mathur |
| Designation |
Professor |
| Affiliation |
Jawaharlal Nehru Medical College,Ajmer |
| Address |
Anaesthetic Consultant room , orthopedic operation theatre, orthopedic department,jawahar lal nehru
hospital,ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414003933 |
| Fax |
|
| Email |
drpoojarawat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monica Gupta |
| Designation |
Resident doctor |
| Affiliation |
Jawaharlal Nehru medical College and hospital ajmer |
| Address |
Room no 16,New operation theatre, anesthesia department, Jawaharlal nehru hospital,ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9079226324 |
| Fax |
|
| Email |
monicaguptadoc10@gmail.com |
|
|
Source of Monetary or Material Support
|
| New operation theatre, anaesthesia department,jawaharlal nehru medical college and hospitals,ajmer |
|
|
Primary Sponsor
|
| Name |
jawaharlal nehru medical college ajmer |
| Address |
jawaharlal nehru medical college ajmer |
| 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 Pooja mathur |
Jawaharlal nehru medical hospital |
Orthopedic Modular and Emergency operation theatre, orthopedic department,jawaharlal nehru hospital, ajmer
Ajmer
RAJASTHAN |
9414003933
drpoojarawat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethical committee |
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 |
| Comparator Agent |
A COMPARATIVE STUDY OF ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB ORTHOPEDIC SURGERY |
With due approval from institutional ethical committee, a prospective, hospital based, single blinded, randomized controlled study has been planned on adult patients of either sex for one year.
Study participants will be the patients coming to the orthopedic department planned for upper limb surgeries and listed in the operation theatre in the Department of Anaesthesiology, Jawaharlal Nehru Medical College, Ajmer. A written informed consent will be obtained from all the patients for performance of block after complete explanation about the study protocol, anaesthetic technique, merits and demerits of the procedure and perioperative course of anaesthesia.
Total duration of intervention is one year. |
| Intervention |
A COMPARATIVE STUDY OF ULTRASOUND GUIDED INFRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR UPPER LIMB ORTHOPEDIC SURGERY |
With due approval from institutional ethical committee, a prospective, hospital based, single blinded, randomized controlled study has been planned on adult patients of either sex for one year. Study participants will be the patients coming to the orthopedic department planned for upper limb surgeries and listed in the operation theatre in the Department of Anaesthesiology, Jawaharlal Nehru Medical College, Ajmer. A written informed consent will be obtained from all the patients for performance of block after complete explanation about the study protocol, anaesthetic technique, merits and demerits of the procedure and perioperative course of anaesthesia.Total duration of intervention is one year. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1 Age group above 18 years.
2 Patients belonging to ASA (American Society of Anaesthesiologists) class-I and II.
|
|
| ExclusionCriteria |
| Details |
1 Patients not willing to participate in the study and not giving consent.
2 Uncooperative patients.
3 Patient with chronic pain or on long-term analgesics.
4 Any known hypersensitivity or contraindication to bupivacaine or any other local anesthetic.
5 Local pathology at the site of injection or disability limiting the performance of block.
6 Patients with coagulopathies and bleeding diathesis
7 Neurological diseases or pre existing nerve palsies
8 Inadequate block necessitating institution of general anaesthesia for continuation of surgical procedure.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Sensory block onset time |
to be assesed by grading points using 3 point scale by pinprick test just after giving the drug in intervals of half min till effect comes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Time to perform the block
2) Number of needle attempts
3) Motor block onset time
4) Motor block duration
5)Sensory block duration
6)First analgesic requirements
7)Adverse effects
|
according to grading point scale for motor & sensory blocks & vas score at 2 min intervals from the time of giving block till 10 min followed by 5 min till 30 min,15 min intervals till 2hrs ,2 hrs interval till 6 hrs & then 6 hrs interval till 24 hrs of giving the block |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/02/2024 |
| 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="0"
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
|
With due approval from institutional ethical committee, a prospective, hospital based, single blinded, randomized controlled study has been planned on adult patients of either sex. Study participants will be the patients coming to the orthopedic department planned for upper limb surgeries and listed in the operation theatre in the Department of Anaesthesiology, Jawaharlal Nehru Medical College, Ajmer. A written informed consent will be obtained from all the patients for performance of block after complete explanation about the study protocol, anaesthetic technique, merits and demerits of the procedure and perioperative course of anaesthesia.A comparative study of ultrasound guided supraclavicular and infraclavicular approach of brachial plexus block will be done and sensory block onset will be compared in both the approaches along with other outcome measurements as mentioned in above texts. |