| CTRI Number |
CTRI/2024/01/061732 [Registered on: 23/01/2024] Trial Registered Prospectively |
| Last Modified On: |
11/01/2024 |
| 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
|
Comparing the painfree period after adding dexamethasone and methylprednisolone with Ropivacaine in supraclavicular brachial plexus block in patient undergoing upperlimb orthopaedic surgeries |
|
Scientific Title of Study
|
A Comparision of efficacy of Dexamethasone and methylprednisolone used as an adjuvant with 0.5%Ropivacaine under ultrasound guided supraclavicular brachial plexus block |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrARVIND KHARE |
| Designation |
Senior Professor |
| Affiliation |
Jawahar lal nehru medical college |
| Address |
Department of Anaesthesiology new OT 1st floor Jawaharlal nehru medical college and hospitals ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrARVIND KHARE |
| Designation |
Senior Professor |
| Affiliation |
Jawahar lal nehru medical college |
| Address |
Department of Anaesthesiology New OT 1st floor Jawaharlal nehru medical college and hospitals Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrARVIND KHARE |
| Designation |
Senior Professor |
| Affiliation |
Jawahar lal nehru medical college |
| Address |
Department of Anaesthesiology New OT 1st floor Jawaharlal nehru medical college and hospitals Ajmer
Ajmer
RAJASTHAN
305001
India |
| Phone |
9414306114 |
| Fax |
|
| Email |
arvindkhare68@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology New OT 1st floor Jawahar lal nehru medical college and hospital Kalabhag Ajmer Rajasthan 305001 |
|
|
Primary Sponsor
|
| Name |
JLN medical college |
| Address |
kalabagh ajmer rajasthan 305001 |
| 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 |
| DrRAVI SHARMA |
Jawaharlal Nehru Medical College |
Orthopaedic OT 2nd floor JLN OPD building kalabhag Jawahar lal nehru medical college and hospital Ajmer
Ajmer
RAJASTHAN |
9602839188
makru161089@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Jawahar Lal Nehru Medical College and Hospitals Ajmer |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M966||Fracture of bone following insertion of orthopedic implant, joint prosthesis, or bone plate, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj. Methylprednisolone |
With due approval from intitutional ethical committee a double blinded randomised study will be conducted on 40 patients who will be undergoing various orthopaedic surgeries around elbove and forearm. inj.Methylprednisalone 40mg is used as an adjuvant with inj.Rpopivacaine 0.5% 30ml is given as USG guided supraclavicular block as one time injection. A written informed consent will be taken in prior to procedure. Participants will be followed and monitored for duration of analgesia at specified interval till they complain of pain in postoperative period then the study will be terminated. data will be collected and analysed using standard qualitative and quantitative tests. A p value of less than 0.05 will be considered as significant. |
| Intervention |
inj.Dexamethasone |
with due approval from institutional ethical committee a double blinded randomised study will be conducted on 40 patients who will be undergoing various orthopedic surgeries around elbove and forearm. inj.Dexamethsone 8mg is used as an adjuvant with inj.Rpopivacaine 0.5% 30ml is given as USG guided supraclavicular block as one time intervention. A written informed consent will be taken in prior to procedure. Participants will be followed and monitored for duration of analgesia at specified interval till they complain of pain in postoperative period and once there is complaining of pain study is terminated. data will be collected and analysed using standard qualitative and quantitative tests. A p value of less than 0.05 will be considered as significant. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.body weight 40kg to 80kg
2.patient belong to ASA I and II
3.Patient undergoing various orthopaedic surgeries around elbove and forearm |
|
| ExclusionCriteria |
| Details |
1.patient refusal
2. ASA grade III and more
3. pregnancy
4. neuropathy of surgical limb
5. local pathology at site of injection od drug |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of Analgesia |
Pain is assessed using VAS SCORE at immediate post operatively then at every 1 hr interval till 24 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Onset & Duration of Sensory block
2.Onest & Duration of Motor block
3.Adverse effect |
1. Every 3 minutes up to 30 minute then every 30 minutes till regression of sensory block
2. Every 3 minutes up to 30 minute then every 30 minutes till regression of motor block
3. Baseline , 5minute,10minute,30minute,45minute,60minute,90minute,120minute & 150 minute |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
24/01/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
this will be a double blinded randomized study conducted to evaluate and compare inj. dexamethasone 8mg and inj. methylprednisolone 40 mg as an adjuvent with inj. Ropivacaine 0.5% 30 ml given as USG guided supraclavicular block in patients undergoing various orthopaedic surgical procedure around elbow and forearm with a primary objective to compare duration of analgesia and secondary objectives being onset and duration of sensory block, onset and duration of motor block, and adverse effect . Participants will be allocated in to group RD who will be receiving inj. dexamethasone and group RM who receiving inj. methylprednisolone with local anaesthetic agent in doses as described earlier and will be monitored intraoperatively and post operatively at described interval and study parameters will be recorded and data will be analysed using standard qualitative and quantitative test . P value of less than 0.05 will be considered significant. |