| CTRI Number |
CTRI/2023/07/054840 [Registered on: 06/07/2023] Trial Registered Prospectively |
| Last Modified On: |
05/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between Perineural vs intravenous magnesium sulphate as an adjuvant to levobupivacaine using ultrasound |
|
Scientific Title of Study
|
Comparison of perineural & intravenous magnesium sulphate as an adjuvant to levobupivacaine in ultrasound – guided supraclavicular brachial plexus block: A prospective randomized trial |
| 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 Koushallya Sri S |
| Designation |
Second year postgraduate |
| Affiliation |
Chettinad Academy Of Research and Education |
| Address |
Chettinad Academy Of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
7299224444 |
| Fax |
|
| Email |
akskoush@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Anand S |
| Designation |
Professor |
| Affiliation |
Chettinad academy of research and education |
| Address |
Department of Anaesthesiology Chettinad Academy Of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam
Department of Anaesthesiology Chettinad Academy Of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
9444486183 |
| Fax |
|
| Email |
dranandmurugan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Koushallya Sri S |
| Designation |
Second year postgraduate |
| Affiliation |
Chettinad Academy Of Research and Education |
| Address |
Chettinad Academy Of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam
Chennai
TAMIL NADU
603103
India |
| Phone |
7299224444 |
| Fax |
|
| Email |
akskoush@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chettinad Academy of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam ,603103 |
|
|
Primary Sponsor
|
| Name |
Chettinad Academy of Research and Education |
| Address |
Chettinad Academy of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam ,603103 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Koushallya Sri S |
Chettinad hospital and research institute |
Department of anaesthesia ,A block ,2nd floor Chettinad Academy of Research and Education ( Deemed to be university ) Chettinad health city Rajiv Gandhi salai ( OMR ) Kelambakkam ,603103
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
7299224444
akskoush@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee For Student Research ( Care IHEC-1 ) |
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 |
Intravenous magnesium sulphate |
patient will receive 0.5% levobupivacaine (24.5ml) with 0.5ml NS total volume of 25ml in usg guided supraclavicular nerve block plus 30 mg/kg iv magnesium sulphate
Total duration - 1 year |
| Comparator Agent |
Perineural and intravenous magnesium sulphate |
Group 1 perineural magnesium sulphate – patient will receive 0.5% levobupivacaine (24.5ml) with 250 mg of magnesium sulphate (0.5ml) total volume of 25ml in usg guided supraclavicular nerve block Group 2 intravenous magnesium sulphate – patient will receive 0.5% levobupivacaine (24.5ml) with 0.5ml NS total volume of 25ml in usg guided supraclavicular nerve block plus 30 mg/kg iv magnesium sulphate |
| Intervention |
Perineural magnesium sulphate |
patient will receive 0.5% levobupivacaine (24.5ml) with 250 mg of magnesium sulphate (0.5ml) total volume of 25ml in usg guided supraclavicular nerve block
Total duration - 1 year |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age between 18 - 60 years 2.Both sexes 3. ASA Classes I,II and III patients 4. Patients posted for upper limb surgery below shoulder |
|
| ExclusionCriteria |
| Details |
1.Patient refusal 2. Coagulopathy 3. History of allergy to local anesthetics 4. Infection at the site of block 5. Neurodeficit involving brachial plexus 6. Pregnant women 7. Patients with psychiatric behavior 8. ASA Class IV patients
9.Obese patients BMI>35kg/m2 |
|
|
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 |
| To compare the onset of sensory & motor block |
One year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •To compare the duration of analgesia •To compare the requirement of rescue analgesic in the postoperative period • To compare the side effects (if any) |
One year |
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
14/07/2023 |
| 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="2"
Days="2" |
|
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
|
To compare analgesic efficacy between perineural and intravenous magnesium sulphate as an adjuvant to levobupivacaine in ultrasound-guided supraclavicular brachial plexus block
Group 1 perineural magnesium sulphate – patient will receive 0.5% levobupivacaine (24.5ml) with 250 mg of magnesium sulphate (0.5ml) total volume of 25ml in usg guided supraclavicular nerve block Group 2 intravenous magnesium sulphate – patient will receive 0.5% levobupivacaine (24.5ml) with 0.5ml NS total volume of 25ml in usg guided supraclavicular nerve block plus 30 mg/kg iv magnesium sulphate
Primary objective •To compare the onset of sensory and motor block Secondary objective •To compare the duration of analgesia •To compare the requirement of rescue analgesic in the postoperative period •To compare the side effects (if any) |