| CTRI Number |
CTRI/2022/12/048082 [Registered on: 13/12/2022] Trial Registered Prospectively |
| Last Modified On: |
07/12/2022 |
| 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 between two drugs that which provides longer pain free time after upper limb surgery surgery |
|
Scientific Title of Study
|
Comparative study of 0.5% Ropivacaine plus magnesium sulfate versus 0.5% Ropivacaine plus Dexmedetomidine as an adjuvant in 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 |
Subhashree Sahu |
| Designation |
PG RESIDENT |
| Affiliation |
VIMSAR, BURLA |
| Address |
Department of anesthesiology
VIMSAR, BURLA
SAMBALPUR
Sambalpur
ORISSA
768017
India |
| Phone |
7655040459 |
| Fax |
|
| Email |
rosysubhashreesahu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Subhashree Sahu |
| Designation |
PG RESIDENT |
| Affiliation |
VIMSAR, BURLA |
| Address |
Department of anesthesiology
VIMSAR, BURLA
SAMBALPUR
Sambalpur
ORISSA
768017
India |
| Phone |
7655040459 |
| Fax |
|
| Email |
rosysubhashreesahu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Subhashree Sahu |
| Designation |
PG RESIDENT |
| Affiliation |
VIMSAR, BURLA |
| Address |
Department of anesthesiology
VIMSAR, BURLA
SAMBALPUR
Sambalpur
ORISSA
768017
India |
| Phone |
7655040459 |
| Fax |
|
| Email |
rosysubhashreesahu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Subhashree Sahu |
| Address |
Department of anesthesiology
VIMSAR,BURLA |
| 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 |
| Dr Dulal Kishun Soren |
VIMSAR, BURLA |
Orthopaedic OT Room no 24
Department of anesthesiology
VIMSAR, BURLA
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: S518||Open wound of forearm, (2) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Name Details Add New
1 INTERVENTION Comparative study of Ropivacaine plus Dexmedetomidine and Ropivacaine plus magnesium sulfate in brachial plexus block |
Patients divided into two groups. 1 group of patients received inj Ropivacaine 0.5% 25ml plus inj Dexmedetomidine 0.7mcg/kg and another group of patients received inj Ropivacaine 0.5% 25ml plus inj magnesium sulfate 4mg/kg |
| Intervention |
Comparative study of Ropivacaine plus Dexmedetomidine and Ropivacaine plus magnesium sulfate in brachial plexus block |
Patients divided into two groups. 1 group of patients received inj Ropivacaine 0.5% 25ml plus inj Dexmedetomidine 0.7mcg/kg and another group of patients received inj Ropivacaine 0.5% 25ml plus inj magnesium sulfate 4mg/kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with forearm fracture of ASA PS-I, II, WEIGHT -40Kg to 70 kg to be included in the study |
|
| ExclusionCriteria |
| Details |
Patient refusal, infection at the site of block, known allergy to the drugs uesd in the study, patients with coagulation disorder |
|
|
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 provide longer duration of analgesia than magnesium sulfate |
VAS SCORE will be assessed at base line, 1hr,2hr,4hr,8hr,12hr,18hr,24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Total Rescue analgesia requirement will be less in Dexmedetomidine group than magnesium sulfate group |
VAS SCORE at 0hr, 1hr,2hr,4hr,6hr,12hr,24hr to be measured. |
|
|
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 will be divided into two groups.1 group will receive inj Ropivacaine 0.5% plus inj Dexmedetomidine 0.7mcg/kg and another group will receive inj Ropivacaine 0.5% plus inj magnesium sulfate 4mg/kg..VAS score will be measured at 0hr, 1hr,2hr,4hr,6hr,12hr,24hr |