| CTRI Number |
CTRI/2022/11/047044 [Registered on: 04/11/2022] Trial Registered Prospectively |
| Last Modified On: |
02/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to compare the effect of fentanyl and dexmedetomidine when added to 0.5% Bupivacaine in brachial plexus block for upper limb surgeries |
|
Scientific Title of Study
|
CLINICAL STUDY TO COMPARE THE EFFECT OF FENTANYL AND DEXMEDETOMIDINE AS AN ADJUVANT TO 05% BUPIVACAINE IN NERVE STIMULATOR GUIDED SUPRACLAVICULAR BRACHIAL PLEXUS BLOCK FOR 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 |
Madiha Mehmood Ansari |
| Designation |
Postgraduate resident |
| Affiliation |
Peoples College of Medical Science and research centre, Bhanpur, Bhopal. |
| Address |
Department of Anaesthesia
PCMS and RC
Bhopal
MP
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8839880699 |
| Fax |
|
| Email |
madihaansari93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditya Agarwal |
| Designation |
Professor and HOD |
| Affiliation |
Peoples College of Medical Science and research centre, Bhanpur, Bhopal. |
| Address |
Department of Anaesthesia
PCMS and RC
Bhopal
MP
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
|
| Fax |
|
| Email |
ph.anaesthsia@peoplesuniversity.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Madiha Mehmood Ansari |
| Designation |
Postgraduate resident |
| Affiliation |
Peoples College of Medical Science and research centre, Bhanpur, Bhopal. |
| Address |
Department of Anaesthesia
PCMS and RC
Bhopal
MP
Bhopal
MADHYA PRADESH
462001
India |
| Phone |
8839880699 |
| Fax |
|
| Email |
madihaansari93@gmail.com |
|
|
Source of Monetary or Material Support
|
| Peoples College of Medical Science & Research centre, Bhopal |
|
|
Primary Sponsor
|
| Name |
Madiha Mehmood Ansari |
| Address |
Department of Anaesthesia
PCMS and RC
Bhopal
MP |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Madiha Mehmood Ansari |
People’s College of Medical Science and Research Center |
Department of Anaesthesia
People’s College of Medical Science and Research Center
Bhopal
MP
Bhopal
MADHYA PRADESH |
8839880699
madihaansari93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Peoples College of Medical Science and Research Center Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S510||Open wound of elbow, (2) ICD-10 Condition: S529||Unspecified fracture of forearm, (3) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexmedetomidine |
0.5% bupivacaine hydrochloride 30 ml to which 1μg/kg Dexmedetomidine will be added and given for supraclavicular brachial plexus block before the start of Surgery and after complete sensory & motor block has been achieved.
Drug will be instilled only once. Pt. will be monitored till effect of drug wears of. |
| Comparator Agent |
Fentanyl |
0.5% bupivacaine hydrochloride 30 ml to which 1μg/kg fentanyl will be added and given for supraclavicular brachial plexus block before the start of Surgery and after complete sensory & motor block has been achieved.
Drug will be instilled only once. Pt. will be monitored till effect of drug wears of. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age18 years - 60 years
- ASA grade 1 and 2
- Scheduled for elective upper limb surgeries under supraclavicular brachial plexus
block.
|
|
| ExclusionCriteria |
| Details |
Lack of patient’s consent. - Age <18yrs and >60yrs.- ASA grade 3 and more.
- History of serious pulmonary disease, ischemic heart disease, renal/hepaticdysfunction, coronary artery, or cervical spine disease and patients with abnormal coagulation profile. - Patient with h/o opioid abuse.
- Patients with local skin site infections.
- Patients with hypersensitivity to any of the drugs used.
- Pregnant and lactating mothers.
- Failure of Block
- Restricted neck movement. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the efficacy of 0.5% Bupivacaine with dexmedetomidine, 0.5% Bupivacaine with fentanyl and 0.5% Bupivacaine innerve stimulator guided supraclavicular brachial plexus block. |
First 24 hours at 5 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hour, 4 hours, 6 hours, 12 hours and 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare side effects of 0.5% Bupivacaine with dexmedetomidine, 0.5% Bupivacaine with fentanyl and 0.5% Bupivacaine innerve stimulator guided supraclavicular brachial plexus block. |
First 24 hours at 5 mins, 10 mins, 15 mins, 30 mins, 1 hour, 2 hour, 4 hours, 6 hours, 12 hours and 24 hours |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
10/11/2022 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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 comparing of dexmedetomidine and fentanyl as adjuvant
to Bupivacaine in brachial plexus block. Considering the low side effect and
excellent postoperative analgesic efficacy of two drugs, it is essential to
carry out a comparative evaluation of two drugs for their use with bupivacaine as
adjuvant in patients undergoing upper limb surgeries which require
supraclavicular brachial plexus block. To compare whether adding dexmedetomidine
and fentanyl to bupivacaine for supraclavicular brachial plexus block would
affect the sensory and motor blocks and duration of analgesia. The present work has been undertaken to study
and compare the effect provided by dexmedetomidine and fentanyl as adjuvants to
bupivacaine in supraclavicular block. |