| CTRI Number |
CTRI/2024/02/062255 [Registered on: 05/02/2024] Trial Registered Prospectively |
| Last Modified On: |
03/02/2024 |
| 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
|
Ropivacaine vs Magnesium with Ropivacaine in Supraclavicular Brachial plexus block in post operative pain relief. |
|
Scientific Title of Study
|
Effect of Magnesium with Ropivacaine in Supraclavicular Brachial plexus block in post operative analgesia : Randomized control study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr K Cheran |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Department Of Anaesthesia OT Complex 1st floor Vinayaka Missions Medical College and Hospital Keezhakasakudi Medu Kottucherry Post Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
8610184741 |
| Fax |
|
| Email |
anscheran.k73@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr K Cheran |
| Designation |
Professor |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Department Of Anaesthesia OT Complex 1st floor Vinayaka Missions Medical College and Hospital Keezhakasakudi Medu Kottucherry Post Karaikal
Karaikal
PONDICHERRY
609609
India |
| Phone |
8610184741 |
| Fax |
|
| Email |
anscheran.k73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Adibur Rahman |
| Designation |
Postgraduate |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Room no 101 First Floor Department of Anaesthesia Vinayaka Missions Medical College and Hospital Keezhakasakudi Medu Kottucherry Post
Karaikal
PONDICHERRY
609609
India |
| Phone |
8880888714 |
| Fax |
|
| Email |
adiburrahman.777@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Research Foundation, NH47, Sankari main road, Salem 636308 |
|
|
Primary Sponsor
|
| Name |
Adibur Rahman |
| Address |
401b,macro orchid apartment, 5th cross, Benson town, Bengaluru 560046 |
| 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 Adibur Rahman |
Vinayaka missions medical college and hospital |
Room No 101 First Floor Department of Anaesthesiology Keezhakasakudy Medu kottucherry post
Karaikal
PONDICHERRY |
8880888714
adiburrahman.777@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M973||Periprosthetic fracture around internal prosthetic shoulder joint, (2) ICD-10 Condition: M974||Periprosthetic fracture around internal prosthetic elbow joint, (3) 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 |
Plain Ropivacaine 0.75% |
Patients will receive Supraclavicular Nerve Block with Plain Ropivacaine 0.75% one dose 20 minutes before the surgery and Patient will be monitored till complete recovery from block which will take upto 24 hours. |
| Intervention |
Ropivacaine 0.75% with MgSO4 |
Patients will receive Supraclavicular Nerve Block with Ropivacaine 0.75% along with MgSO4 500mg one dose 20 minutes before the surgery and Patient will be monitored till complete recovery from block which will take upto 24 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1,2 and 3
Patient with upper limb surgeries willing for Supraclavicular Nerve Blocks |
|
| ExclusionCriteria |
| Details |
Allergy to Drug
Patient Refusal to Nerve Block
Contraindications to supraclavicular nerve block and Ropivacaine
Patient unable to express VAS score accurately
BMI greater than 35 |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| compare postoperative analgesia of Ropivacaine with or without magnesium |
0hrs 6hr 12 hr and 24hrs post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Onset & duration of action of block
time to need for rescue analgesia |
0hr 6hrs 12hrs & 24hrs |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
14/02/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Magnesium sulphate is known to be used for preventing seizures in certain conditions and also has speculated muscle relaxant properties and analgesic properties. The purpose of this study is to evaluate the effect of Addition of Magnesium with Ropivacaine in Supraclavicular Brachial Plexus Nerve Block for Postoperative analgesic properties alone. |