| CTRI Number |
CTRI/2021/07/034681 [Registered on: 08/07/2021] Trial Registered Prospectively |
| Last Modified On: |
07/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of efficiency of two different doses of magnesium sulphate when added to local anesthetic in supraclavicular block( which are given in upper limb surgeries) in reducing post operative pain |
|
Scientific Title of Study
|
Randomised controlled double blind study to compare the efficacy of two doses of magnesium sulphate as an adjuvant to local anesthetics in supraclavicular block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SUHAIL ASHRAF |
| Designation |
JUNIOR RESIDENT ACADEMIC ANAESTHESIA |
| Affiliation |
BHARATI VIDYAPEETH DEEMED UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY
BHARATI HOSPITAL AND RESEARCH CENTRE, BHARATI VIDYAPEETH DEEMED UNIVERSITY, DHANKAWADI, PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
7907154962 |
| Fax |
|
| Email |
drsuhailashraf94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SHWETA KONNUR |
| Designation |
ASSOCIATE PROFESSOR, DEPARTMENT OF ANAESTHESIA |
| Affiliation |
BHARATI VIDYAPEETH DEEMED UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIA, BHARATI HOSPITAL AND RESEARCH CENTRE, PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
9823890369 |
| Fax |
|
| Email |
sjmane81@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR SHWETA KONNUR |
| Designation |
ASSOCIATE PROFESSOR, DEPARTMENT OF ANAESTHESIA |
| Affiliation |
BHARATI VIDYAPEETH DEEMED UNIVERSITY |
| Address |
DEPARTMENT OF ANAESTHESIA, BHARATI HOSPITAL AND RESEARCH CENTRE, PUNE
Pune
MAHARASHTRA
411043
India |
| Phone |
9823890369 |
| Fax |
|
| Email |
sjmane81@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| BHARATI HOSPITAL AND RESEARCH CENTRE |
|
|
Primary Sponsor
|
| Name |
Bharati hospital and research centre Pune |
| Address |
Department of anaesthesia Bharati Vidyapeeth deemed university Dhankawadi Pune |
| Type of Sponsor |
Private 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 |
| DR SUHAIL ASHRAF |
BHARATI HOSPITAL AND RESEARCH CENTRE |
DEPARTMENT OF ANAESTHESIA, MAJOR OT COMPLEX,3RD FLOOR
Pune
MAHARASHTRA |
7907154962
drsuhailashraf94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee, Bharati Vidyapeeth (deemed to be university) medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S529||Unspecified fracture of forearm, (2) ICD-10 Condition: S423||Fracture of shaft of humerus, (3) ICD-10 Condition: S424||Fracture of lower end of humerus, (4) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, (5) ICD-10 Condition: M200||Deformity of finger(s), (6) ICD-10 Condition: V224||Motorcycle driver injured in collision with two- or three-wheeled motor vehicle in traffic accident, (7) ICD-10 Condition: V124||Pedal cycle driver injured in collision with two- or three-wheeled motor vehicle in traffic accident, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
magnesium sulphate |
Addition of magnesium sulphate as an adjuvant to local anesthetics(lignocaine and bupivacaine)in supraclavicular block for post operative analgesia |
| Comparator Agent |
magnesium sulpahte 150 mg for 12 months |
Addition of magnesium sulphate 150mg as an adjuvant to local anesthetics(lignocaine and bupivacaine)in supraclavicular block for post operative analgesia |
| Comparator Agent |
magnesium sulpahte 250 mg for 12 months |
Addition of magnesium sulphate 250 mg as an adjuvant to local anesthetics(lignocaine and bupivacaine)in supraclavicular block for post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
PATIENT AGED BETWEEN 18 TO 60 YEARTS OF AGE
BOTH SEXES
ASA GRADE I AND II
POSTED FOR ELECTIVE UPPER LIMB SURGERY UNDER SUPRACLAVICULAR BLOCK |
|
| ExclusionCriteria |
| Details |
PATIENT REFUSAL TO PARTICIPATE IN STUDY
PATIENT ALLERGIC TO LOCAL ANAESTHETIC AGENTS
PATIENT ON CHRONIC TREATMENT WITH CALCIUM CHANNEL BLOCKERS
PATIENT WITH HEART BLOCK
PATIENT ON ANTICOAGULANTS
PATIENT WITH PRE EXISTING NEUROPATHY |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
DURATION OF POST OPERATIVE ANALGESIA
|
ONSET AND DURATION OF MOTOR AND SENSORY BLOCK
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| TOTAL ANALGESIC REQUIREMENT |
POST OPERATIVELY FOR TWENTY FOUR HOURS |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
27/07/2021 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a randomised controlled double blinded prospective study to compare the efficacy of two different doses of magnesium sulphate 150 mg and 250 mg when added to local anesthetics in USG Guided supraclavicular block in elective upper limb surgeries .Total 90 patients aged between 18 to 60 years will be divided into two groups , Group M1- 12 ml 0.5% Bupivacaine plus 12 ml 2% lignocaine with adrenaline plus magnesium sulphate 150 mg( 0.3ml), Group M2- 12 ML 0.5% Bupivacaine plus 12 ml 2% lignocaine with adrenaline plus magnesium sulphate 250 mg(0.5 ml) and we compare the following parameters- Onset and duration of sensory block, Onset and duration of motor block, Duration of post operative analgesia, total analgesic requirement in 24 hours & monitor for side effects if any. |