| CTRI Number |
CTRI/2021/08/035547 [Registered on: 10/08/2021] Trial Registered Prospectively |
| Last Modified On: |
06/08/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effects of fentanyl and dexmedetomidine in pain relief |
|
Scientific Title of Study
|
A COMPARATIVE EVALUATION OF THE EFFECTS OF
FENTANYL AND DEXMEDETOMIDINE AS AN ADJUANT TO BUPIVACAINE
IN ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SHAMSE ALAM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
jnmch amu aligarh |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH.A.M.U ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9634367980 |
| Fax |
|
| Email |
shamsealam91@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
QAZI EHSAN ALI |
| Designation |
PROFESSOR |
| Affiliation |
jnmch amu aligarh |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH.A.M.U ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7417701769 |
| Fax |
|
| Email |
qaziehsanali@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SHAMSE ALAM |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
jnmch amu aligarh |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH.A.M.U ALIGARH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9634367980 |
| Fax |
|
| Email |
shamsealam91@yahoo.com |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE JNMCH AMU ALIGARH |
|
|
Primary Sponsor
|
| Name |
JNMCH |
| Address |
A.M.U ALIGARH UP 202002 |
| 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 |
| SHAMSE ALAM |
JAWAHAR LAL NEHRU MEDICAL COLLEGE |
DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE,JNMCH.A.M.U ALIGARH
Aligarh
UTTAR PRADESH |
9634367980
shamsealam91@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S423||Fracture of shaft of humerus, (2) ICD-10 Condition: S520||Fracture of upper end of ulna, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group I-Fentanyl group(Group F): 25 ml solution of
bupivacaine 0.3% and fentanyl at a dose of 1mcg/kg of body weight,total
volume made upto 30 ml.
Group II-Dexmedetomidine group(Group D): 25 ml solution
of bupivacaine 0.3% and dexmedetomidine at a dose of 1mcg/kg of body
weight,total volume made upto 30 ml |
Effects on onset and duration of block and postoperative analgesia in
ultrasound guided supraclavicular brachial plexus block. |
| Comparator Agent |
Group III-Control group(Group C):25 ml solution of
bupivacaine0.3% and 5 ml normal saline. |
Effects on onset and duration of block and postoperative analgesia in
ultrasound guided supraclavicular brachial plexus block. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)ASA I&II Patients of either sex.
2)Age between 15-60 yrs.
3)Weight 40-80kg.
4)Patients planned for elective upper limb surgery |
|
| ExclusionCriteria |
| Details |
1)Patients with cardiovascular diseases like coronary artery disease, hypertension
,heart blocks etc.
2)Patients with disease like diabetes ,peripheral neuropathy, coagulopathy.
3)Infection at the site of block .
4)Patients with known allergy to local anaesthetic and patients on adrenoceptor
agonist or antagonists. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the effect of fentanyl and dexmedetomidine as an adjuant to
bupivacaine on onset and duration of block and postoperative analgesia in
ultrasound guided supraclavicular brachial plexus block.
|
base line
immediately after injection
every 15 min till 2 hrs
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the haemodynamic changes –
a) Heart Rate(HR)
b)Blood Pressure(BP)-Systolic BP(SBP), Diastolic BP(DBP),Mean Arterial
Pressure(MAP).
c) Oxygen Saturation(Spo2)
2. To look for complication ,if any |
10 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
15/08/2021 |
| 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="10"
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)?
Response - NO
|
|
Brief Summary
|
TITLE OF THESIS:A COMPARATIVE EVALUATION OF THE EFFECTS OF FENTANYL AND DEXMEDETOMIDINE AS AN ADJUANT TO BUPIVACAINE IN ULTRASOUND GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK. IINTRODUCTION: In general, regional nerve blockade avoids the unwanted effects of anaesthetic drugs used during general anaesthesia and is beneficial for the patients with various cardio-respiratory co-morbidities. Brachial plexus block is the most popular technique to deal with the upper limb surgeries.Various adjuants ,including opioids , midazolam, magnesium sulfate, dexamethasone, and neostigmine have been added to local anaesthetics in an attempt to increase the duration of block and post-operative analgesia.Various clinical trials have found that administration of dexmedetomidine and fentanyl with local anaesthetics in neuraxial and peripheral nerve blocks prolonged the duration of sensory and motor blockade. However, there are limited data available on comparison of dexmedetomidine and fentanyl as adjuant to local anaesthetics in brachial plexus block. HYPOTHESIS:Dexmedetomidine is better than fentanyl in terms of duration of both motor and sensory blocks and postoperative analgesia. |