| CTRI Number |
CTRI/2022/10/046410 [Registered on: 12/10/2022] Trial Registered Prospectively |
| Last Modified On: |
26/09/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study Comparing the Efficacy of three different doses of Magnesium Sulphate as Adjuvant to Ropivacaine for Supraclavicular Brachial plexus block |
|
Scientific Title of Study
|
Efficacy of the three different doses of Magnesium Sulphate as an adjuvant in Supraclavicular Brachial plexus block for upper limb surgeries. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yamni S V |
| Designation |
Post graduate |
| Affiliation |
Sri Venkateswara Medical college. |
| Address |
Sri Venkateswara Medical College,
Department of Anesthesiology,
pondicherry,
21/35,viyayasudha illam,sundapattivilai,southsoorankudi post,kanniyakumari dist,
629501
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9843714928 |
| Fax |
|
| Email |
yamuraji22@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Jayashridevi |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
Sri Venkateswara Medical college. |
| Address |
Department of Anesthesiology,
Sri Venkateswara medical college,
Pondicherry,
NO 21,Annai theresa street,
Raja Nagar, pondicherry .
Pondicherry
PONDICHERRY
605102
India |
| Phone |
8754689690 |
| Fax |
|
| Email |
dr.jayashridevi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yamni S V |
| Designation |
Post graduate |
| Affiliation |
Sri Venkateswara Medical college. |
| Address |
Sri Venkateswara Medical College,
Department of Anesthesiology,
pondicherry,
Department of Anesthesiology,
pondicherry,
605102
Pondicherry
PONDICHERRY
605102
India |
| Phone |
9843714928 |
| Fax |
|
| Email |
yamuraji22@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateshwara Medical College Hospital and Research Centre. |
|
|
Primary Sponsor
|
| Name |
Sri Venkateshwara Medical College Hospital and Research Centre |
| Address |
13 A Pondy Villupuram main road Ariyur,Pudhucherry 605102 |
| 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 |
| Yamni S V |
Sri Venkateshwara Medical College Hospital and Research Centre. |
Department of Anesthesiology,Sri Venkateshwra Medical College hospital and Research centre,13 A Pondy Villupuram Main road,Ariyur,
Pondicherry
PONDICHERRY |
9843714928
yamuraji22@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwaraa Medical College Hospital and Research Centre. |
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 |
| Intervention |
Motor and Sensory blockade following Supraclavicular brachial plexus block |
Efficacy of three differet doses of Magnesium Sulphate as an adjuvant to 0.5% Ropivacaine. |
| Comparator Agent |
Supraclavicular brachial plexus block |
Onset of motor and sensory blockade and postoperative analgesia for 0.5%Ropivacaine with 125mg Magnesium sulphate |
| Comparator Agent |
Supraclavicular brachial plexus block |
Onset of motor and sensory blockade and postoperative analgesia for 0.5%Ropivacaine with 250mg Magnesium sulphate. |
| Comparator Agent |
Supraclavicular brachial plexus block. |
Onset of motor and sensory blockade and postoperative analgesia for 0.5%Ropivacaine with 150mg Magnesium sulphate |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1,Patient undergoing elective upper limb surgeries,
2,Age 18-60 years
3,Body weight 45-75kg
4,ASA I and II |
|
| ExclusionCriteria |
| Details |
1,Patient Refusal
2,Age <18years and age >65 years.
3,pregnant Women
4,ASA III and above
5,infection at the site of block
6,H/O allergy to local anesthetic drugs. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset of sensory and motor blockade following administration of supraclavicular block. |
The onset and degree of sensory and motor block will be observed and recorded for the first 30 mins in every 5 minute interval. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Compare the hemodynamic changes, Nausea, Vomiting, Pruritis. |
Outcome is assessed immediately after surgery and up to 24 hours after surgery. |
|
|
Target Sample Size
|
Total Sample Size="72"
Sample Size from India="72"
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
|
N/A |
|
Date of First Enrollment (India)
|
20/10/2022 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is to compare three different doses of magnesium sulphate as an adjuvant to 0.5% Ropivacaine for supraclavicular brachial plexus block in upper limb surgeries for analgesia and to evaluate the safety of the respective techniques. The techniques used here Brachial Plexus Block – Supraclavicular Approach. The Nerves supplying the Upper Limb pass through the areas around the Clavicle. So, blocking the nerves above the clavicle can lead to the blockade of functions of the nerves supplying the upper limb. This is known as the Supraclavicular block. The study aims to compare the efficacy of three different doses of Magnesium sulphate as an adjuvant to 0.5% Ropivacaine for analgesia. |