CTRI Number |
CTRI/2023/02/050078 [Registered on: 24/02/2023] Trial Registered Prospectively |
Last Modified On: |
23/02/2023 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A Study comparing two different doses of Injection Dexmedetomidine when added to Injection Levobupivacaine (0.5% concentration) for ultrasound guided supraclavicular brachial plexus nerve block in elective upper limb surgeries. |
Scientific Title of Study
|
A Comparative study between two different doses of Dexmedetomidine as adjuvant to 0.5 % Levobupivacaine 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 |
Dr Noel Tobin |
Designation |
Junior Resident |
Affiliation |
Mgm mediacal college |
Address |
Room NO 570 OT Complex
Mgm medical college aurangabad Maharashtra MGM MEDICAL
COLLEGE AND
HOSPITAL N6 CIDCO
AURANGABAD
MAHARASHTRA Aurangabad MAHARASHTRA 431003 India |
Phone |
9496982892 |
Fax |
|
Email |
noeltobinm@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Pramod Vasantrao Bhale |
Designation |
Professor |
Affiliation |
Mgm Medical college |
Address |
Department of Anaesthesia MGM Medical College and Hospital N6
CIDCO Aurangabad Department of Anaesthesia MGM Medical
College and Hospital N6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA
Aurangabad MAHARASHTRA 431003 India |
Phone |
8888819021 |
Fax |
|
Email |
pramod.bhale@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Pramod Vasantrao Bhale |
Designation |
Professor |
Affiliation |
Mgm mediacal college |
Address |
Department of Anaesthesia MGM Medical College and Hospital N6
CIDCO Aurangabad Department of Anaesthesia MGM Medical
College and Hospital N6 CIDCO Aurangabad
Aurangabad
MAHARASHTRA
Aurangabad MAHARASHTRA 431003 India |
Phone |
8888819021 |
Fax |
|
Email |
pramod.bhale@gmail.com |
|
Source of Monetary or Material Support
|
MGM MEDICAL COLLEGE AND HOSPITAL AURANGABAD |
|
Primary Sponsor
|
Name |
MGM Medical College and Hospital Aurangabad |
Address |
Department of Anaesthesia MGM Medical College and Hospital N6
CIDCO Aurangabad |
Type of Sponsor |
Private 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 Noel Tobin |
MGM MEDICAL COLLEGE AND HOSPITAL |
OT ROOM NO 6 OT COMPLEX MGM MEDICAL
COLLEGE AND
HOSPITAL N6 CIDCO
AURANGABAD
MAHARASHTRA Aurangabad MAHARASHTRA |
9496982892
noeltobinm@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
MGM Ethics Committee For Research on Human Subjects |
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 |
Intervention |
Levobupivacaine Plus Dexmedetomidine |
Supraclavicular brachial plexus block with 20 ml 0.5% Levobupivacaine plus 0.5 microgram per kilogram dexmedetomidine under ultrasound guidance. |
Intervention |
Levobupivacaine Plus Dexmedetomidine |
Supraclavicular brachial plexus block with 20 ml 0.5% Levobupivacaine plus 1 microgram per kilogram dexmedetomidine under ultrasound guidance. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
65.00 Year(s) |
Gender |
Both |
Details |
1.Patients of ASA physical grade I –II
2.18-65 years of age
3.Both sexes
4.Posted for elective surgeries of midarm forearm and hand will be included. |
|
ExclusionCriteria |
Details |
1.Patient refusal
2.History of infection at site of block
3.Coagulopathies
4.Patients with known hypersensitivity to local anaesthetic or dexmedetomidine
5.Presence of 1st, 2nd or 3rd degree heart block
6.Pregnant women
7.Patients on beta blockers
Pre-existing peripheral neuropathy
|
|
Method of Generating Random Sequence
|
Other |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1)Heart rate
2)Mean arterial pressure
3)Saturation
|
1.Time at which procedure of giving block is finished.
2)Five minute
3)Ten minute
3)Fifteen minute
4)Twenty minute
5)Fourty minute
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1.Heart rate
2.Mean arterial pressure
3.Intraoperative sedation score
|
1)Sixty minute
2)Eighty minute
3)Hundred minute
4)One twenty minute
5)One fourty minute |
|
Target Sample Size
|
Total Sample Size="36" Sample Size from India="36"
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 4 |
Date of First Enrollment (India)
|
28/02/2023 |
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="2" Months="0" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Brachial plexus block has evolved into an excellent substitute to general anaesthesia for upper limb surgeries. It curtails the stress response and using minimal anaesthetic drugs it provides intraoperative analgesia with prolonged post operative pain relief. Among the various upper limb blockades, supraclavicular brachial plexus block (SCBP) is considered as ’spinal of arm’. Brachial plexus block is a peripheral block commonly used for upper limb surgery. Ultrasound guided supraclavicular brachial plexus block facilitate more accurate and effective method of drug administration. Levobupivacaine is used for this study as it has advantages of long acting and less cardiotoxic and neurotoxic. Levobupivacaine has recently been used more for supraclavicular brachial plexus block due to the above mentioned advantages. The idea behind using an adjuvant with local anaesthetic is to reduce the requirement of analgesics in post operative period. Various adjuvants have been studied for prolonging the effect of supraclavicular blocks(4). Alpha 2 adrenoreceptor agonist such as clonidine and dexmedetomidine are the two most commonly used drugs. They have shown sedation, analgesia, sympatholysis,cardiac stabilization and anaesthetic sparing properties. Out of these dexmedetomidine an imidazole compoind is more selective than clonidine(eight times).Dexmedetomidine causes analgesia by its action at supraspinal (locus coeruleus) or at spinal level or even at peripheral Alpha 2 receptors by the reduction of transmission of nociceptive stimulus.(2). This study compares the effects of two different doses of dexmedetomidine as an adjuvant added to 0.5% Levobupivacaine. In our study we are using ultrasound guided technique for supraclavicular brachial plexus block. In this study we hypothesise that two different doses of dexmedetomidine (0.5 & 1 microgram per kg) are equallyt effective. |