| CTRI Number |
CTRI/2020/09/027929 [Registered on: 21/09/2020] Trial Registered Prospectively |
| Last Modified On: |
18/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two doses of Dexamethasone in nerve block for relieving pain following arm surgery. |
|
Scientific Title of Study
|
Comparative evaluation of analgesic efficacy of different dose of Dexamethasone as adjuvant to Levobupivacaine in ultrasound guided brachial plexus block in 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 |
Sohini Dutta |
| Designation |
Post graduate trainee Anaesthesiology. |
| Affiliation |
Institute of post graduate medical education and research |
| Address |
Kotalhat
D.D Tewari road
244 AJC Bose road
Department of Anaesthesiology
Kolkata
700020
West Bengal
Kolkata
WEST BENGAL
713102
India |
| Phone |
7980970919 |
| Fax |
|
| Email |
sohinid4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Baisakhi Laha |
| Designation |
Associate Professsor, Department of Anaesthesiology |
| Affiliation |
Institute of Post graduate medical education and research, Kolkata |
| Address |
244 AJC Bose road
Department of Anaesthesiology
Kolkata
West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830148042 |
| Fax |
|
| Email |
blowfans@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Maitreyee Mukherjee |
| Designation |
Associate Professsor, Department of Anaesthesiology |
| Affiliation |
Institute of Post graduate medical education and research, Kolkata |
| Address |
Basanti Village
143/1D South Sinthee Road
Kolkata 700050
West Bengal
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830415924 |
| Fax |
|
| Email |
maitreyee1980.mm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology
IPGMER |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
IPGME&R
244 AJC Bose road
kolkata |
| Type of Sponsor |
Government 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 Baisakhi Laha |
Department of Anaesthesiology IPGMER |
244 AJC Bose road
Kolkata
700020
Kolkata
WEST BENGAL |
9830148042
blowfans@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGMER Research Oversight Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
2 mg Dexamethasone |
As an adjuvant to 0.5% Levobupivacaine in ultrasound guided brachial plexus block in upper limb surgeries for post operative analgesia |
| Comparator Agent |
4 mg Dexamethasone |
As an adjuvant to 0.5 % Levobupivacaine in ultrasound guided brachial plexus block in upper limb surgeries for post operative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA I and II Mallampati grade 1 and 2 posted for upper limb surgeries |
|
| ExclusionCriteria |
| Details |
Coagulopathies (INR>1.5)
Infection at site of block
A compromised lung function at opposite side of block like pneumothorax hemothorax pneumonectomy
Hypersensitivity to Local anaesthetics or Dexamethasone
Patients refusal or inability to communicate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Duration of effective post operative analgesia |
24 hours post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Time of onset of sensory and motor block
|
24 hours post operative period |
| Duration of sensory and motor block |
24 hours post operative period |
| VAS score |
24 hours post operative period |
| Incidence of post operative nausea vomiting |
24 hours post operative period |
| Rate of infection neurologic complication hyperglycemia |
24 hours post operative period |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
22/09/2020 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study will compare the analgesic efficacy of two dose of Dexamethasone as adjuvant to Levobupivacaine in ultrasound guided supraclavicular brachial plexus block for upper limb surgeries |