| CTRI Number |
CTRI/2018/04/012975 [Registered on: 03/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
02/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of two different drugs for providing longer postoperative pain relief after upper arm surgery done under supraclavicular brachial plexus block. |
|
Scientific Title of Study
|
To Compare The Effectiveness Of Magnesium sulphate And Ketamine As Adjuvant to Ropivacaine For Supraclavicular Brachial Plexus Block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ruchi Gupta |
| Designation |
Hod,Professor |
| Affiliation |
sri Gruramdas university of health sciences and research |
| Address |
Department Of Anaesthesia and Critical care,Sgrdimsar
Sri Guru Ramdas University
Amritsar
PUNJAB
143501
India |
| Phone |
9814320805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil Chawla |
| Designation |
Professor |
| Affiliation |
SGRDIMSAR |
| Address |
Department Of Anaesthesia And Critical Care,SGRDIMSAR
Sri Guru Ramdas University
Amritsar
PUNJAB
1435001
India |
| Phone |
9915530033 |
| Fax |
|
| Email |
drchawla30@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Jonny Dhawan |
| Designation |
PG RESIDENT |
| Affiliation |
SGRDIMSAR |
| Address |
Department Of Anaesthesia,Sri Gruram Das Institute Of Medical Sciences And Research
H.NO 1030 Adarsh Colony,Backside Thapar University,Patiala
Amritsar
PUNJAB
143001
India |
| Phone |
9915926761 |
| Fax |
|
| Email |
jonnydhawan074@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRI GRURAMDAS INSTITUTE OF MEDICAL SCIENCES AND RESEARCH,AMRITSAR |
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical Sciences And Research |
| Address |
Vallah Amritsar |
| 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 Jonny Dhawan |
Sri Guru Ram Das institute of Medical Sciences and Research |
Operating Room,main operating room complex 2nd floor Sgrd hospital
Amritsar
PUNJAB |
9915926761
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE SGRDIMSAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Upper limb surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DRUGS-Ropivacaine,Ropivacaine with magnesium sulphate250mg,Ropivacaine with ketamine2mg/kg |
To compare the pain relief and complication after supraclavicular administration of magnesium sulphate and ketamine as adjuvant to ropivacaine or comlications due to procedure itself in upper limb surgeries.the study will be conducted in 105 patients posted foe upper limb surgery.
The data thus Group–I (Ropivacaine alone) –35 patients will recieve 27ml of 0.5% Ropivacaine with 3ml of normal saline .
Group–II (Ropivacaine+Magnesium) –35 patients will receive 27ml of 0.5% Ropivacaine with Magnesium Sulphate 250mg (1ml normal saline) and 2ml of normal saline..
Group-Ó€Ó€Ó€ (Ropivacaine+ketamine) -35 patients will recieve 27 ml of .5% Ropivacaine with Ketamie(2mg/kg) and rest normal saline to make it 30 ml.
The data thus collected will be statistically analysed
|
| Intervention |
Supraclavicular brachial plexus block using ropivacaine alone vs ketamine as adjuvant to ropivacaine vs magnesium sulphate as adjuvant to ropivacaine |
To compare postoperative pain relief using magnesium sulphate and ketamine as adjuvant to ropivacaine in supraclavicular brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
patient posted for surgeries of upper limb,ASA GRADE 1 & 2 |
|
| ExclusionCriteria |
| Details |
Patient refusal.
Local infection at needle insertion site.
Coagulopathy.
Patient on anticoagulants.
Pneumothorax or previous pneumonectomy on the opposite side.
|
|
|
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 POSTOPERATIVE ANALGESIA |
Duration of analgesia from drug administration to VAS equals to or more than 4 in postoperative period in first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Requiement of doses of rerscue analgesia
|
First 24 hours |
To compareside effects and complications
Doses of rescue analgesia requirement |
In first 24 hours |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
01/02/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
None Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
To compare the pain relief and complication after supraclavicular administration of magnesium sulphate and ketamine as adjuvant to ropivacaine or complications arising due to procedure itself in upper limb surgeries.the study will be conducted in 105 patients posted foe upper limb surgery. The data thus Group–I (Ropivacaine alone) –35 patients will recieve 27ml of 0.5% Ropivacaine with 3ml of normal saline . Group–II (Ropivacaine+Magnesium) –35 patients will receive 27ml of 0.5% Ropivacaine with Magnesium Sulphate 250mg (1ml of 500mg drug diluted with 1ml of distilled water) and 2ml of normal saline.. Group-ӀӀӀ (Ropivacaine+ketamine) -35 patients will recieve 27 ml of .5% Ropivacaine with Ketamie(2mg/kg) and rest normal saline to make it 30 ml. The data thus collected will be statically analysed
|