| CTRI Number |
CTRI/2022/12/048083 [Registered on: 13/12/2022] Trial Registered Prospectively |
| Last Modified On: |
12/12/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs for pain free time in hand surgeries. |
|
Scientific Title of Study
|
Comparative study between Dexmedetomidine and Dexamethasone as an adjuvant to Bupivacaine in supraclavicular brachial plexus block 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 |
Madhusmita Kundu |
| Designation |
Post graduate student |
| Affiliation |
VIMSAR, Burla |
| Address |
Department of anesthesiology, VIMSAR, Burla
Sambalpur
ORISSA
768017
India |
| Phone |
8917541089 |
| Fax |
|
| Email |
madhusmitakundu777@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Madhusmita Kundu |
| Designation |
Post graduate student |
| Affiliation |
VIMSAR, Burla |
| Address |
Department of anesthesiology, VIMSAR, Burla
ORISSA
768017
India |
| Phone |
8917541089 |
| Fax |
|
| Email |
madhusmitakundu777@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Madhusmita Kundu |
| Designation |
Post graduate student |
| Affiliation |
VIMSAR, Burla |
| Address |
Department of anesthesiology, VIMSAR, Burla
ORISSA
768017
India |
| Phone |
8917541089 |
| Fax |
|
| Email |
madhusmitakundu777@gmail.com |
|
|
Source of Monetary or Material Support
|
| VIMSAR, BURLA , Dist- Sambalpur, state- odisha, PIN- 768017 |
|
|
Primary Sponsor
|
| Name |
Madhusmitakundu Kundu |
| Address |
VIMSAR, Burla, Sambalpur , odisha, PIN-768017, India |
| 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 |
| Professor Dr Dulal kishun Soren |
Orthopaedic OT,VIMSAR,Burla |
VIMSAR, BURLA,SAMBALPUR
Sambalpur
ORISSA |
9437254980
dulalsoren@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| VIREC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S523||Fracture of shaft of radius, (2) ICD-10 Condition: S521||Fracture of upper end of radius, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Suraclavicular brachial plexus block |
Patients divided into 2groups. Group DX and group DM.All patients underwent ultrasound guidance supraclavicular brachial plexus block with 20ml of 0.5 % bupivacaine. Group DX received 50mcg Dexmedetomidine and Group DM received 4mg of Dexamethasone as an adjuvant to bupivacaine. |
| Comparator Agent |
Suraclavicular brachial plexus block |
Patients divided into 2groups. Group DX and group DM.All patients underwent ultrasound guidance supraclavicular brachial plexus block with 20ml of 0.5 % bupivacaine. Group DX received 50mcg Dexmedetomidine and Group DM received 4mg of Dexamethasone as an adjuvant to bupivacaine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Forearm fracture, with ASA status l , ll and weight 50-70kg to beincluded in the study. |
|
| ExclusionCriteria |
| Details |
Patients refusal, Infection at the site of block, coagulopathy or bleeding disorders, alcohol or drug abuse, patients with psychiatric disorders, known allergies to any drug to be used, failed block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Dexmedetomidine provides prolonged duration of analgesia than dexamethasone |
0, 1, 2, 4,6,12,24 hours after completion of injection |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset of sensory and motor block to be observed |
1,2,4,6,7,10, 12,15,20,25 minutes |
|
|
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/12/2022 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
60 patients with upper limb surgeries to be taken for this study. Patients to be divided into two groups (group DX and group DM) Group DX will receive inj Dexmedetomidine 50mcg and group DM will receive inj dexamethasone 4 mg along with inj Bupivacaine 20ml 0.5%. onset of sensory and motor block and duration of analgesia to be observed. |