| CTRI Number |
CTRI/2020/03/023757 [Registered on: 04/03/2020] Trial Registered Prospectively |
| Last Modified On: |
15/10/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study effect of Dexamethasone on duration of analgesia(pain relief) in brachial plexus block by Bupivacaine(local anaesthetic) |
|
Scientific Title of Study
|
USG guided brachial plexus block: A comparison of analgesia duration using Bupivacaine with and without Dexamethasone as adjuvant. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gurpuneet Singh Basra |
| Designation |
Anaesthesiologist |
| Affiliation |
Air Force Hospital |
| Address |
92-3
Doctors Enclave
7 Air Force Hospital
Kanpur Cantt
Kanpur 208004
UP
Kanpur Dehat
UTTAR PRADESH
208004
India |
| Phone |
|
| Fax |
|
| Email |
drbasra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditya Sapra |
| Designation |
HOD |
| Affiliation |
Air Force Hospital |
| Address |
91-2
Doctors Enclave
7 Air Force Hospital
Kanpur Cantt
Kanpur 208004
UP
Kanpur Dehat
UTTAR PRADESH
208004
India |
| Phone |
|
| Fax |
|
| Email |
adityasapra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya Sapra |
| Designation |
HOD |
| Affiliation |
Air Force Hospital |
| Address |
91-2
Doctors Enclave
7 Air Force Hospital
Kanpur Cantt
Kanpur 208004
UP
Kanpur Dehat
UTTAR PRADESH
208004
India |
| Phone |
|
| Fax |
|
| Email |
adityasapra@gmail.com |
|
|
Source of Monetary or Material Support
|
| 7 Air Force Hospital
Nathu Singh Road
Kanpur Cannt
Kanpur - 208004
UP |
|
|
Primary Sponsor
|
| Name |
IAF |
| Address |
7 Air Force Hospital
Kanpur Cantt
Kanpur 208004
UP |
| Type of Sponsor |
Other [Government 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 |
| Aditya Sapra |
Air Force Hospital |
7 Air Force Hospital
Kanpur Cantt
Kanpur 208004
UP
Kanpur Dehat
UTTAR PRADESH |
9680019684
adityasapra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S598||Other specified injuries of elbowand forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Brachial plexus block |
Dexamethasone 4 mg will be added as adjuvant to the local anaesthetic solution. No repeat dose will be administered. |
| Comparator Agent |
Brachial plexus block |
Normal saline as placebo will be added to the local anaesthetic solution. No repeat dose will be administered. |
| Intervention |
Brachial plexus block |
supraclavicular approach |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Posted for Open Reduction Internal Fixation of UpperLimb fractures
2. Upper limb surgery where Supraclavicular brachial plexus block is indicated |
|
| ExclusionCriteria |
| Details |
1. Weight less than 40 Kg
2. Pregnancy
3. Poor sensorium (GCS < 13)
4. Contraindications to Dexamethasone
5. Diabetes Mellitus
6. Patients on current steroid therapy or within past 6 weeks |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Compare the duration of Analgesia of brachial plexus block and time to first additional analgesic |
Measured over 48 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of motor weakness of arm measured every 6 hours |
Measured over 48 hours |
| Postoperative blood sugar every 6 hours |
Measured over 48 hours |
|
|
Target Sample Size
|
Total Sample Size="32"
Sample Size from India="32"
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 3 |
|
Date of First Enrollment (India)
|
09/03/2020 |
| 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="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Other (Terminated) |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Brachial plexus block is one of the preferred techniques for anaesthesia for upper limb surgeries. The advantage being that of analgesia lasting even after the anaesthesia with motor block wears off. Many adjuvants have been explored for co-administration along with the local anaesthetic to prolong this period. Each of these adjuvants has its own side effect profile, with this study we will attempt at understanding the analgesic effect and duration and also the side effect profile by comparing blood sugar levels and duration of motor blockade. |