| CTRI Number |
CTRI/2022/07/043833 [Registered on: 07/07/2022] Trial Registered Prospectively |
| Last Modified On: |
05/08/2023 |
| 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
|
Comparison between two ultrasound guided methods of axillary brachial plexus block for upper limb surgeries. |
|
Scientific Title of Study
|
A study to compare ultrasound guided perifascial versus perivascular approach to axillary brachial plexus block in elective upper limb surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jatin Lal |
| Designation |
Professor |
| Affiliation |
Pt. B. D. Sharma PGIMS Rohtak |
| Address |
Dept of Anaesthesiology,
Pt. B. D. Sharma PGIMS, Rohtak
Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jatin Lal |
| Designation |
Professor |
| Affiliation |
Pt. B. D. Sharma PGIMS Rohtak |
| Address |
Dept of Anaesthesiology,
Pt. B. D. Sharma PGIMS, Rohtak
Rohtak.
HARYANA
124001
India |
| Phone |
9728265511 |
| Fax |
|
| Email |
dr.jatinlal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Nilanjana Sarkar |
| Designation |
Junior Resident |
| Affiliation |
Pt. B. D. Sharma PGIMS Rohtak |
| Address |
Dept of Anaesthesiology,
Pt. B. D. Sharma PGIMS, Rohtak
Rohtak.
Rohtak
HARYANA
124001
India |
| Phone |
8444028358 |
| Fax |
|
| Email |
brishtineel96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dept. of Anaesthesiology,
Pt. B. D. Sharma PGIMS,
Rohtak (Haryana) |
|
|
Primary Sponsor
|
| Name |
Dept of Anaesthesiology Pt B D Sharma PGIMS Rohtak |
| Address |
Pt. B. D. Sharma PGIMS, Rohtak 124001 (Haryana) |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jatin Lal |
Pt. B. D. Sharma PGIMS |
Department of Anaesthesiology and Critical Care
Rohtak
HARYANA |
9728265511
dr.jatinlal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided perifascial approach to axillary brachial plexus block will be used. |
Ultrasound guided axillary brachial plexus block will given by perifascial plane approach with 20 ml of 0.5% bupivacaine and lignocaine 2% with epinephrine (1:200000) local anaesthetic mixture. |
| Comparator Agent |
Ultrasound guided perivascular approach to axillary brachial plexus block will be used. |
Ultrasound guided axillary brachial plexus block will given by perivascular approach with 20 ml of 0.5% bupivacaine and lignocaine 2% with epinephrine (1:200000) local anaesthetic mixture. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients scheduled to undergo elective distal upper limb surgery of elbow, forearm, wrist and hand.
2. Patients with American Society Of Anesthesiologists status I-III.
3. Expected duration of surgery less than 2 hours
|
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating female patients.
2. Patients with known coagulopathy or on anticoagulant therapy.
3. Patients with diabetes mellitus, receiving opioids for chronic pain therapy.
4. Patients with infection at the injection site.
5. Patients with allergy to local anaesthetic drugs used.
6. Patients with psychiatric illness or inability to give informed consent. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| - To compare the performance time of perifascial and perivascular approaches of brachial plexus block. |
- Start of identification of Injection locations on ultrasound.
- End of local anaesthetic injection. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| - Success rate of perifascial and perivascular approaches of axillary plexus block. |
- Achievement of surgical anaesthesia at 30 min. |
| - Ease of performance as judged by the anaesthesiologist giving block in both the techniques. |
- After completion of axillary plexus block by respective techniques. |
| - Patient satisfaction in both the techniques of Axillary Plexus block. |
- Immediately after completion of block procedure.
- At the end of surgery. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/07/2022 |
| 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
|
Years="0"
Months="6"
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)?
Response - NO
|
|
Brief Summary
|
Peripheral nerve blocks today are a major component of perioperative multimodal analgesia. Ultrasonography (USG) guidance has allowed improved efficacy of the technique by providing direct visualization of the block performance and local anaesthetic injection. Axillary brachial plexus block has become the most used peripheral nerve block for elbow, forearm, wrist and hand surgery. The aim of the study is to compare perivascular and perifascial approaches of ultrasound guided axillary brachial plexus block in elbow, forearm, wrist and hand surgeries. The primary objective is to compare the performance time of perifascial and perivascular approaches of brachial plexus block. The secondary objectives are to assess the success rate, ease of performance as judged by operator and patient satisfaction of the two respective techniques of axillary brachial plexus block.
The present prospective, randomized, single blinded study will be conducted in the Department of Anaesthesiology and Critical Care, Pt. B. D. Sharma PGIMS, Rohtak. Patients of either sex, 18-80 years old, ASA I-III, who are scheduled to undergo elective elbow, forearm, wrist and hand surgeries of less than 2 hrs duration will be included in study. Pregnant and lactating females, patients with known coagulopathy or on anticoagulant therapy, diabetes mellitus, neuropathy, receiving opioids for chronic pain therapy, having infection at the injection site, allergic to local anesthetics (LA) and having psychiatric illness will be excluded from study. The patients will be divided into one of the two groups of 20 patients each using computer generated randomization number table.
Group - PF (n=20): patients will be administered USG guided perifascial axillary brachial plexus block. Group - PV (n=20): patients will be administered USG guided perivascular axillary brachial plexus block. Performance time, success rate, ease of performance, patient satisfaction of perifascial and perivascular approaches of brachial plexus block will be noted and analysed by appropriate statistical tests.
|