| CTRI Number |
CTRI/2018/02/011974 [Registered on: 19/02/2018] Trial Registered Prospectively |
| Last Modified On: |
19/02/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Role of regional anaesthesia for upper limb surgeries |
|
Scientific Title of Study
|
To study the efficacy of nalbuphine and magnesium sulphate with ropivacaine for quality of supraclavicular brachial plexus block and post operative analgesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Joginder Pal Attri |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia |
| Address |
Govt Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9501025175 |
| Fax |
|
| Email |
drjpattri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Joginder Pal Attri |
| Designation |
Professor |
| Affiliation |
Department of Anaesthesia |
| Address |
Govt Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9501025175 |
| Fax |
|
| Email |
drjpattri@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Joginder Pal Attri |
| Designation |
Professor |
| Affiliation |
Deptt of Anaesthesia |
| Address |
Govt Medical College, Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9501025175 |
| Fax |
|
| Email |
drjpattri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Deptt of Anaesthesia, Govt Medical College, Amritsar |
|
|
Primary Sponsor
|
| Name |
Joginder Pal Attri |
| Address |
Deptt of Anaesthesia, Govt Medical College, Amritsar |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Amar Parkash Kataria |
Deptt of Anaesthesia, Govt Medical College, Amritsar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Joginder Pal |
Govt Medical College Amritsar |
Department of Anaesthesia
Amritsar
PUNJAB |
9501025175
drjpattri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA grade I and II, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade I and II and age group 20-65 years |
|
| ExclusionCriteria |
| Details |
ASA grade III and IV, pregnant patients and those on anti coagulants |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of sensory and motor blockade and post operative analgesia |
Time in minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Haemodynamic changes, Any side effects and patient satisfaction score |
from 0-60 minutes |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2018 |
| 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="1"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Supraclavicular brachial plexus block is the most frequently used approch for anaesthesia and post operative analgesia for surgeries of upper limbs. Various adjuvants are added to local anesthetics for prolonging duration of analgesia. This will be a prospective randomised double blind study which will be done to compare the efficacy of nalbuphine and mahnesium sulphate as adjuvants to ropivacainae and ropivacaine alone in supra claviculaaar brachial plexus block using nerve stimulator
|