| CTRI Number |
CTRI/2021/04/033190 [Registered on: 28/04/2021] Trial Registered Prospectively |
| Last Modified On: |
05/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of a drug dexmedetomidine when given intramuscularly and in nerve block in patients receiving anaesthesia for forearm and hand surgeries |
|
Scientific Title of Study
|
Comparison of dexmedetomidine in ultrasound guided supraclavicular brachial plexus
block versus intramuscular administration in 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 |
Sanjana S |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9952612396 |
| Fax |
|
| Email |
sanjanasubbiah44@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Abhishek Rao Kordcal |
| Designation |
Associate Professor |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9886118906 |
| Fax |
|
| Email |
abhi.rao@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Sanjana S |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9952612396 |
| Fax |
|
| Email |
sanjanasubbiah44@gmail.com |
|
|
Source of Monetary or Material Support
|
| Principal Investigator Dr Sanjana S, Junior Resident, Dept of Anaesthesiology
Kasturba Medical College,
Manipal,
Udupi 576104 |
| Student Research Fund, Dept of Anesthesiology, KMC Manipal |
|
|
Primary Sponsor
|
| Name |
Sanjana S |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Manipal, Udupi |
| Type of Sponsor |
Other [] |
|
|
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 SANJANA S |
Kasturba Hospital Manipal |
Department of Anesthesiology
Kasturba Hospital
Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka 576104
Udupi
KARNATAKA |
9952612396
sanjanasubbiah44@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
im dexmedetomidine |
Patient will be given supracalvicular brachial plexus block with 30ml 0.5% levobupivacaine followed by dexmedetomidine 1 mcg/kg intramuscularly on the same arm as the nerve block |
| Intervention |
perineural dexmedetomidine |
Patient will be given supraclavicular brachial plexus block with 30 ml 0.5% levobupivacaine and 1 mcg/kg dexmedetomidine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All the patients undergoing elective and emergency upper limb surgeries under ultrasound-guided supraclavicular brachial plexus block with the American Society of Anaesthesiologists (ASA) physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Patient refusal.
2. History of allergic medications used in the study.
3. Patients with difficulty in communication.
4. Underlying conditions- bleeding disorders, local infection, existing brachial plexus
deficits.
5. History of treatment for a chronic pain condition/ psychiatric disorder.
6. Pregnant women. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Onset and duration of sensory blockade
Onset and duration of motor blockade |
From the time of administration of study drug- every 5 minutes till 30 minutes, every 30
minutes till 2 hours, every 4 hours till 12 hours and then every 6 hours up to 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time taken for rescue analgesia
Sedative effect
Overall patient satisfaction. |
From the time of administration of study drug- every 5 minutes till 30 minutes, every 30
minutes till 2 hours, every 4 hours till 12 hours and then every 6 hours up to 24 hours. |
|
|
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)
|
01/05/2021 |
| 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="1"
Months="6"
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
|
Supraclavicular brachial plexus blocks are commonly administered in upper limb surgeries. Adjuvants such as dexmedetomidine, clonidine, dexamethasone etc are added in the block to prolong the duration of the block as well as for sedation and analgesia. There are multiple studies comparing the effects of dexmedetomidine given intravenously and perineurally in supraclavicular brachial plexud blocks. A route other than intravenous injection or a low dose may help minimize cardiovascular risks such as bradycardia and hypotension associated with dexmedetomidine. However, few studies have addressed the clinical effects of low-dose intramuscular dexmedetomidine as premedication- and those studies were done in comparison to general anesthesia or in pediatric age group. This research question aims to bridge the existing gaps in literature as it compares the efficacy intramuscular and perineural dexmedetomidine in supraclavicular blocks in adults. |