| CTRI Number |
CTRI/2024/04/066163 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
This study is being conducted to compare two doses of intravenous dexamethasone for prolongation of analgesia in axillary block in patient undergoing mid arm surgeries |
|
Scientific Title of Study
|
A Placebo Controlled study to compare two doses of intra-venous dexamethasone for Prolongation of analgesia in axillary Brachial plexus block . |
| 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 Mangal Ahlawat |
| Designation |
Associate professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care .PGIMS rohtak pt.b.d sharma University of health sciences
Rohtak
HARYANA
124001
India |
| Phone |
9812989930 |
| Fax |
|
| Email |
drmangalahlawat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mangal Ahlawat |
| Designation |
Associate professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care .PGIMS rohtak pt.b.d sharma University of health sciences
Rohtak
HARYANA
124001
India |
| Phone |
9812989930 |
| Fax |
|
| Email |
drmangalahlawat@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mangal Ahlawat |
| Designation |
Associate professor |
| Affiliation |
PGIMS Rohtak |
| Address |
Department of Anaesthesiology and critical care .PGIMS rohtak pt.b.d sharma University of health sciences
Rohtak
HARYANA
124001
India |
| Phone |
9812989930 |
| Fax |
|
| Email |
drmangalahlawat@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt.BD sharma PGIMS rohtak |
|
|
Primary Sponsor
|
| Name |
PGIMS ROHTAK pt.B.D sharma University of health sciences |
| Address |
Department of anesthesiology and critical care at pt.b.d Sharma pgims rohtak
Pin-124001 |
| 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 |
| DrPriyanka Rani |
Pr BD sharma PGIMS rohtak |
Department of Anaesthesiology and critical care
Pgims rohtak
PT bd sharma University of health sciences.
Pin-124001
Rohtak
HARYANA |
9468316541
Pinkumew222@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee PGIMS rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical, (3) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided axillary brachial plexus block is given in all patients undergoing below mid arm surgeries |
All block will be performed with sono site Edge 2 ultrasound machine using high frequency (6-13)Mhz linear probe .Block was performed with 23G needle in both the groups .In plane technique is used ,in which entire shaft and tip of needle will be visible .All injection are given with 10ml of 0.5%bupivacaine +2%lignocaine with adrenaline(1:200,000) after confirming negative aspiration and no parasthesia .5ml of local anaesthetic drug mixture will be deposited around musculocutaneous nerve and rest of local anaesthetic mixture will be deposited anterior and posterior to axillary artery .
Onset and efficacy of motor and sensory blockage will be assess at 5min 10min,30min after block . |
| Comparator Agent |
We compare two different dosage of intravenous dexamethasone 4mg vs 8mg in prolongation of analgesia in ultrasound guided axillary brachial plexus block . |
We first put ultrasound guided axillary brachial block and we assess onset of sensory and motor blockage At 5min ,10min ,30min after block .
If found satisfactory effect of block at 30min after block then intravenous dexamethasone 4mg vs 8mg or intravenous NS to be administered as per group allocation .
Analgesic effect will be assess at baseline ,every hourly till 4 hours and then every 30min till 6 hours.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA I-III patients undergoing elective below mid arm surgeries under axillary Brachial plexus block and duration of surgery should be less than 3 hours |
|
| ExclusionCriteria |
| Details |
1)local infection at injection site or sepsis
2)allergy to any local anaesthetic
3)pt.with known coagulopathy or an anticoagulant therapy
4)pt with GERD,cataract ,glaucoma
5)steroid use within 2 weeks of study period
6)systemic fungal infection ,viral infection
7)patient with nerve entrapment or neuropathy after trauma or diabetic neuropathy and uncontrolled diabetes.
8)patient who refuse to give consent
5) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of analgesia is compared between 3 groups of axillary brachial plexus block.
1)d0-i/v NS given
2)d1-i/v 4mg dexamethasone given
3)d2-i/v 8mg dexamethasone given |
We will assess efficacy of block at 30min after block .
We will assess VAS score at
1)Baseline(preblock)
2) every 1 hourly till 4 hours
3) every 30min till 6 hours
4) 24 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Block characteristics (onset and duration )
2)no.of attempt taken for block
3)duration of sensory block
4)duration of motor block
5)VAS
6)Any complications |
1)sensory block duration is time in minutes from end of local anaesthesia injection till return of hand and finger sensation (ts)
2)motor block duration is time in minutes from end of local anaesthesia injection till return of hand and finger movement(TM)
3)VAs ( 0-100) acess at before block ,30min after block ,every 1hourly till 4 hour ,then every 30 min interval till next 2 hour . |
|
|
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/ Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2024 |
| 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="0"
Months="0"
Days="6" |
|
Recruitment Status of Trial (Global)
|
Closed to Recruitment of Participants |
| 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
|
It is a Placebo Controlled study in which we compare 2 doses of I/v dexamethasone (4mg vs 8mg) for Prolongation of analgesia in axillary brachial plexus block .written informed consent will be taken from all the patients.Data will be compiled and analysed with good statistical test . |