CTRI Number |
CTRI/2022/11/047461 [Registered on: 21/11/2022] Trial Registered Prospectively |
Last Modified On: |
18/11/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Comparison of two drugs in brachial plexus block for upper limb surgeries |
Scientific Title of Study
|
Comparison of two doses of dexmedetomidine as adjuvent to 0.5% Ropivacaine in ultrasound guided brachial plexus block in upper limb surgeries-A Randomised Control Trail |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Malti Agrawal |
Designation |
Professor and HOD |
Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
Address |
Room no 2062 B
Anaesthesia Department
Rohilkhand Medical College and Hospital
Pilibhit Bypass Road
Bareilly 243006
Bareilly UTTAR PRADESH 243006 India |
Phone |
9897897050 |
Fax |
|
Email |
dr_malti_agrawal@yahoo.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Malti Agrawal |
Designation |
Professor and HOD |
Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
Address |
Room no 2062 B
Anaesthesia Department
Rohilkhand Medical College and Hospital
Pilibhit Bypass Road
Bareilly 243006
Bareilly UTTAR PRADESH 243006 India |
Phone |
9897897050 |
Fax |
|
Email |
dr_malti_agrawal@yahoo.com |
|
Details of Contact Person Public Query
|
Name |
Dr Pradeep Kumar |
Designation |
JUNIOR RESIDENT |
Affiliation |
ROHILKHAND MEDICAL COLLEGE AND HOSPITAL |
Address |
Room No 45 PG Boys Hostel
Rohilkhand Medical College and Hospital
Pilibhit Bypass Road
Bareilly 243006
Bareilly UTTAR PRADESH 243006 India |
Phone |
9860980503 |
Fax |
|
Email |
kumaar.pradeep97@gmail.com |
|
Source of Monetary or Material Support
|
Rohilkhand Medical College And Hospital |
|
Primary Sponsor
|
Name |
Rohilkhand Medical College and Hospital |
Address |
Rohilkhand Medical College and Hospital
Pilibhit Bypass Road
BAREILLY 243006 |
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 Malti Agrawal |
Openration Theatre Rohilkhand Medical College And Hospital |
Department Of Anaesthesiology Rohilkhand Medical College
Bareilly
UTTAR PRADESH Bareilly UTTAR PRADESH |
9897897050
dr_malti_agrawal@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Ethics Committee |
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 |
Brachial plexus block with ropivacaine and dexmedetomidine |
0.5 % Ropivacaine with 30 micrograms dexmedetomidine in brachial plexus block |
Comparator Agent |
Brachial plexus block with ropivacaine and dexmedetomidine |
0.5% Ropivacaine with 50 micrograms dexmedetomidine in brachial plexus block |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
American society of Anesthesiologist (ASA) grade I or II
Posted for surgery of upper limb under ultrasound guided brachial plexus block.
|
|
ExclusionCriteria |
Details |
Refusal by patient
Patients taking anticoagulants, β- blockers or opioids, psychotropic medication.
Patients with history of significant​neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic disease.
Patients having history of drug and alcohol abuse.
Patients with contraindication to Ropivacaine and dexmedetomidine.
Women with pregnancy or lactating women.
Patients on chronic analgesic therapy, diabetes or having coagulation disorders.
Patient with infection at site of injection. |
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
Method of Concealment
|
Case Record Numbers |
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
Onset of sensory block and duration of sensory block
Onset of motor block and duration of motor block
Duration of postoperative analgesia |
The patient will be evaluated for sensory and motor block for every 2 minutes for first 20 minutes every 3 minutes for next 30 minutes, every 10 minutes for 60 minutes and finally every 15 minutes until the sensory and motor block regresses |
|
Secondary Outcome
|
Outcome |
TimePoints |
Hemodynamic responses to the drug during and after surgery.
Any complication or side effects. |
At 2,4,6,8,10,12,14,16,18,20,30,40,50, 60, 90, 120,180,240,360,480,720 minutes after
the block, the ECG II lead, heart rate, systolic, diastolic, and mean blood pressure, and oxygen saturation will be recorded.
|
|
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
|
N/A |
Date of First Enrollment (India)
|
24/11/2022 |
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="1" Months="0" 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
|
In today’s world brachial plexus block has evolved as an important part of dailyroutine anaesthesiology practice as an substitute to general anaesthesia for upper limb surgeries. This mode of anaesthesia is also considered safe due to its application with an ultrasound guided live imaging. Also, it aids patient in form of providing post operative analgesia and reducing hospital stay that helps patient financially also. The first supraclavicular block was performed in 1912 by kulen kampff byconventional parasthesia technique blind technique. Giving regional anaesthesia by blind technique has an high failure risk and risk of damaging vital anatomical structures. Ultrasound guided regional anaesthesia eliminates this drawback of blind technique.2 In 1978 La Grange introduced application of doppler probe to identify arteries . In regional anaesthesia we use a local anaesthesia that is used to block the brachialplexus. These local anaesthetics have limited duration of action and providing post operativeanalgesia. Ropivacaine being a long acting amino amide is one of foremost drug used inbrachial plexus block. Ropivacaine when compared with bupivacaine and levobupivacainehas lower lipid solubility and hence provide greater sensory and motor blockade duration and also motor function recovery is fast. Ropivacaine when compared with other local anaesthetic like bupivacaine and levobupivacaine is less cardiac and central nervous system toxic drug. It acts on voltage gatedsodium channels that blocks peripheral afferents. Even with use of Ropivacaine it was found that duration of analgesia was limited andpatients complained of post operative pain and opiod administration was required to prolongpost operative analgesia duration. So use of adjuvents with local anaesthetic came into existence such as dexmedetomidine, clonidine, opioids and neostigmine. These helped toprolong post operative analgesia. Opioids are known to cause various side effects like apnea,respiratory suppression, hypoxia so dexmedetomidine provides anaesthesiologists with abetter alternative to opoids and helps to elinminates these side effets. Dexmedetomidine is an alpha 2 receptor blocker agonist that can be used as anadjuvent to local anaesthetic in order to prolong duration of post operative analgesia and to decrease time of onset . Dexmedetomidine has analgesic, sedative antihypertensive and anaesthetic sparing properties that contributes multimodaly. Dexmedetomidine as alpha 2agonist is highly selective (more than 8 times selective as compared to clonidine ) as an adjuvant. Previous studies are present that have compared various local anaesthetics alone andwith combination with adjuvents in brachial plexus blocks for upper limb surgeriesindividually. To our comprehension few study are known to have compared effects ofropivacaine in regional anaesthesia in brachial plexus block in combination with two differentdosages of dexmedetomidine, and access results of these two groups. |