| CTRI Number |
CTRI/2025/04/085255 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
15/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of two adjuvant drugs via regional anaesthesia in patients undergoing upper limb surgeries |
|
Scientific Title of Study
|
Comparative study between magnesium sulphate versus dexamethasone as an adjuvant to 0.5 percent bupivacaine in 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 |
Dr Sabyasachi Mohapatra |
| Designation |
Junior resident |
| Affiliation |
Dr.D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th floor, Hi tech building, Dr.D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
8018060975 |
| Fax |
|
| Email |
97110sachin@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chhaya Suryawanshi |
| Designation |
HOD and Professor, Department of Anesthsiology |
| Affiliation |
Dr.D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th floor, Hi tech building, Dr.D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune
Pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chhaya Suryawanshi |
| Designation |
HOD and Professor, Department of Anesthsiology |
| Affiliation |
Dr.D.Y.Patil Medical College, Hospital and Research Centre |
| Address |
Department of Anaesthesia, 5th floor, Hi tech building, Dr.D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, pune
MAHARASHTRA
411018
India |
| Phone |
9922888201 |
| Fax |
|
| Email |
chhayasuryawanshi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Pharmacy, 5th floor, Hi-tech building, Dr. D.Y.Patil Medical college, Hospital and Research Centre, Sant Tukaram nagar, Pimpri, Pune, Maharashtra, India Pincode- 411018 |
|
|
Primary Sponsor
|
| Name |
Sabyasachi Mohapatra |
| Address |
Department of Anaesthesia, 5th floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune |
| 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 Sabyasachi Mohapatra |
Dr. D.Y Patil Hospital and Research Centre |
Department of Anaesthesia, 5th floor, Hi-tech building, Dr. D.Y.Patil Medical College, Hospital and Research Centre, Sant Tukaram Nagar, Pimpri, Pune 411018
Pune
MAHARASHTRA |
8018060975
97110sachin@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Sub-Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
Patients will be given 28ml bupivacaine 0.5% with 8mg dexamethasone via supraclavicular brachial plexus block |
| Intervention |
Magnesium Sulphate |
Patients will be given 28ml bupivacaine 0.5% with 1ml of 50% magnesium sulphate(500mg) with 1ml normal saline via supraclavicular brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2 fit patients.
Patients aged between 18-60 years of age.
Both male and female gender.
Patients posted for upper limb surgeries below shoulder.
Hemodynamically stable patients with all routine investigations within normal limits.
Written informed consent from the concerned patients.
|
|
| ExclusionCriteria |
| Details |
Patients who are not willing to participate in the study.
Patients with ASA grade 3 and above physical status.
Patients who are aged more than 60 years and less than 18 years of age.
Patients with known allergy to the study drugs.
Patients who are posted for emergency procedures.
Patients with bleeding disorders and those on anticoagulant therapy.
Infection at site of block.
Neuro deficit involving brachial plexus.
Pregnant women.
Patients with psychiatric, neurological, neuromuscular or cardiovascular disease or impaired hepatic or renal function. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare and study the onset and duration of sensory and motor blockade of magnesium sulphate and dexamethasone as an adjuvant to 0.5% Bupivacaine in supraclavicular brachial plexus block |
The sensory block will be evaluated by pin prick sensation and motor block will be assessed with the help of modified bromage scale after injection of study drugs. Vital parameters will be monitored every 5 mins for first 15 mins and every 15 mins till the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of post operative analgesia in both study groups & observe any side effects of both the drugs |
Duration of analgesia will be assessed post surgery & time to rescue analgesia will be assessed 2 hourly after surgery until intervention is required |
|
|
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 4 |
|
Date of First Enrollment (India)
|
01/05/2025 |
| 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 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
|
It is a prospective, randomised, double blinded comparative study to compare magnesium sulphate versus dexamethasone as Ana adjuvant to 0.5% Bupivacaine in supraclavicular brachial plexus block. 60 patients planned for upper limb surgeries below the shoulder will be divided into two groups of 30 patients each: Group A(dexamethasone) and Group B(magnesium sulphate) Objectives include To compare and study the onset of sensory blockade and motor blockade in both study groups. To compare and study the duration of sensory analgesia and motor blockade in both study groups. To compare the duration of post operative analgesia in both study groups. To observe any side effects of both the drugs. |