| CTRI Number |
CTRI/2025/01/079332 [Registered on: 24/01/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effects of analgesia produced by three different doses of magnesium sulphate as adjuvant to ropivacaine in upper limb surgeries under supraclavicular block |
|
Scientific Title of Study
|
Effect of adding different doses of magnesium sulphate as adjuvant to ropivacaine on the duration of analgesia in upper limb surgeries under supraclavicular brachial plexus blockade-A Randomized controlled 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 Shaheen Khan M |
| Designation |
Postgraduate(MD Anaesthesiology) |
| Affiliation |
SRM medical college and research institute |
| Address |
Room no-209 B-block,
second floor,department of anesthesiology,
SRM medical college and research institute, ,kancheepuram,tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7012544948 |
| Fax |
|
| Email |
drshaheenkhan555@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swetha Ramani C K |
| Designation |
Proffesor |
| Affiliation |
SRM medical college and research institute |
| Address |
Room no-209 B-block,
second floor,department of anesthesiology,
SRM medical college and research institute, ,kancheepuram,tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884782554 |
| Fax |
|
| Email |
swethark@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swetha Ramani C K |
| Designation |
Proffesor |
| Affiliation |
SRM Medical College and Research Institute |
| Address |
Room no-209 B-block,
second floor,department of anesthesiology,
SRM medical college and research institute, ,kancheepuram,tamilnadu
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
9884782554 |
| Fax |
|
| Email |
swethark@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM medical college hospital and research institute Kattankulatur,kancheepuram,Tamilnadu-603203,India |
|
|
Primary Sponsor
|
| Name |
SRM medical college hospital and research institute |
| Address |
Room no:209, B-block,second floor, department of anesthesiology, SRM medical college hospital and research institute, kattankulathur,kancheepuram,tamilnadu-603203,India |
| 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 Shaheen Khan M |
SRM medical college and research institute |
Room no-209 B-block,
second floor,department of anesthesiology,SRM medical college hospital and research institute Kattankulatur,kancheepuram,Tamilnadu-603203,India
Kancheepuram
TAMIL NADU |
7012544948
drshaheenkhan555@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Institutional Ethics Committee- Students |
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 |
Ropivacaine with Magnesium Sulphate/ultrasound guided |
0.5 % Ropivacaine 24 ml plus Magnesium sulphate -50mg (as 1ml) under supraclavicular brachial plexus block,and its sensory blockade assessed at 3 minutes,7 minutes interval and motor blockade assessed at 5minutes,10 minutes interval |
| Intervention |
Ropivacaine with Magnesium Sulphate/ultrasound guided |
0.5 % Ropivacaine 24 ml plus Magnesium sulphate -150mg (as 1ml) under supraclavicular brachial plexus block,and its sensory blockade assessed at 3 minutes,7 minutes inerval and motor blockade assessed at 5minutes,10 minutes interval |
| Intervention |
Ropivacaine+ Magnesium Sulphate/ultrasound guided |
0.5 % Ropivacaine 24 ml plus Magnesium sulphate -100mg (as 1ml) under supraclavicular brachial plexus block,and its sensory blockade assessed at 3 minutes,7 minutes interval and motor blockade assessed at 5minutes,10 minutes interval |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients undergoing upper limb orthopedic surgeries under USG guided supraclavicular brachial plexus block ,ASA grade I & ASA II and BMI less than30
|
|
| ExclusionCriteria |
| Details |
1.Patient refusal
2.Pregnancy
3.Patients with abnormal Coagulation profiles and coagulopathies
4.Patients with cardiac diseases, chronic kidney diseases, chronic liver diseases, respiratory diseases
5.Patients with allergy to ropivacaine or magnesium sulphate
6.Preexisting musculocutaneous disorder or neuropathies
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate the total duration of analgesia |
1hr,2hr,3hr,4hr,8hr,12hr,16hr,20hr,24hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To calculate the time of onset of sensory & motor blockade
To calculate time of first rescue analgesia
|
sensory bloackade at intervals of 3 minutes ,7 minutes
Motor blockade at intervals of 5 minutes,10 minutes
first rescue analgesia at 6 hours post surgery
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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)
|
02/02/2025 |
| 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="1"
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
|
A total of 120 patients belonging to age group 18 years to 65years , ASA class I and II scheduled for upper limb orthopaedic surgeries will be prospectively studied. In this double-blinded randomized control trial, Patients will be randomly allocated into three equal study groups each containing 40 patients. Group (A) received 24 ml of 0.5 % Ropivacaine+ 1ml Magnesium Sulphate 50 mg (control group) Group (B) received 24 ml of 0.5 % Ropivacaine + 1ml Magnesium Sulphate 100 mg Group (C) received 24 ml of 0.5% Ropivacaine +1 ml Magnesium Sulphate 150 mg Usg guided supraclavicular brachial plexus block will be given under usg guidance before surgery All patients will be assessed for- Onset of sensory and motor blockade, total duration of analgesia, time of first rescue analgesia, postoperative analgesic requirement, and complications due to the technique, will be recorded. Data collection will be done by observation and measurement of various parameters
|