| CTRI Number |
CTRI/2023/09/057703 [Registered on: 15/09/2023] Trial Registered Prospectively |
| Last Modified On: |
05/09/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of intravenous versus perineural dexamethasone on random blood sugar in patients receiving brachial plexus block |
|
Scientific Title of Study
|
A study to compare the effect of intravenous versus perineural dexamethasone on random blood sugar in patients undergoing upper limb surgery under supraclavicular brachial plexus block |
| 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 Shubhdeep |
| Designation |
Associate Professor |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research, Sri Amritsar |
| Address |
Main Ot complec, Department of Anaesthesia
Amritsar
PUNJAB
143001
India |
| Phone |
9915575859 |
| Fax |
|
| Email |
shubhdeepjassal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preet Kanwal Kaur |
| Designation |
Junior Resident |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Department of Anaesthesia, Sri Guru Ram Das Institute of Medical Sciences and Research, Sri Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9501541361 |
| Fax |
|
| Email |
dr.preet2610@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ruchi Gupta |
| Designation |
Prof and Head |
| Affiliation |
Sri Guru Ram Das Institute of Medical Sciences and Research |
| Address |
Main OT Complex, Department of Anaesthesia
Amritsar
PUNJAB
143001
India |
| Phone |
9814020805 |
| Fax |
|
| Email |
drruchisgrd@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Sri Guru Ram Das Institute of Medical sciences and Research |
| Address |
Deaprtment of Anaesthesia, Mehta Road, Vallah |
| 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 |
| Dr Ruchi Gupta |
Sri Guru Ram Das Institute of Medical Sciences and Research |
Main operation theatre, mehta Road, Vallah
Amritsar
PUNJAB |
9814020805
drruchisgrd@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SGRD Ethical Committee |
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 |
| Comparator Agent |
intravenous Dexamethasone( 0.1 mg/kg ) versus perineural Dexamethasone( 0.1 mg/kg ) versus placebo |
Before performing brachial plexus block till 24 hours |
| Intervention |
RBS monitoring after intravenous Dexamethasone( 0.1 mg/kg ) versus perineural Dexamethasone( 0.1 mg/kg ) versus placebo in patients receiving Supraclavicular brachial plexus block |
Before performing brachial plexus block till 24 hours |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients in class ASA I and II
2.Surgery planned under supraclavicular block
3.Non-Diabetic Patients |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Infection at the site of injection
3. Contraindications to brachial plexus block
4. Hypersensitivity to any drug used in study
5. Pregnancy
6. Patient on anticoagulants
7. Patient on chronic/acute steroid therapy
8. Perioperative dextrose infusions
9. HbA1c >5.5
10. Weight of the patient <40kgs and >100kgs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Difference in blood sugar levels at baseline & after four hours of administration of
dexamethasone by the perineural and intravenous route |
Before performing supraclavicular brachial plexus block then at 4hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Blood sugar levels at 2,4,8 & 24 hours after dexamethasone administration.
Duration of analgesia of the three groups
Requirement of rescue analgesia in the three groups |
Before performing supraclavicular brachial plexus block then at 2,4,8 & 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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/09/2023 |
| 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="0"
Months="9"
Days="0" |
|
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
|
Background: Brachial plexus block is the preferred choice of anaesthesia for upper limb surgeries. Local anaesthetics like lignocaine and bupivacaine are used to provide analgesia and anaesthesia. Bupivacaine is the most commonly used local anaesthetic. Various adjuvants like clonidine, dexamethasone, opioids are used to prolong regional blockade, decrease the dosage of local anaesthetic required, shorten the onset time of block and prolong the duration of post-operative analgesia. Dexamethasone has been used as a perineural adjuvant as well as intravenous analgesic and because of its glucocorticoid properties it may cause hyperglycaemia. Objectives: To compare the difference in blood sugar levels after the administration of dexamethasone by the perineural and intravenous route in supraclavicular brachial plexus block in non-diabetic patients undergoing upper limb surgeries. Material and methods: Total of 105 patients will receive USG guided supraclavicular brachial plexus block with 25mL of 0.5% bupivacaine. They’ll be randomly allocated to one of the three study groups of 35 each. Group I: 0.1mg/kg dexamethasone diluted in 2 mL normal saline (NS) (perineural) + 100 mL NS (Intravenous); Group II: 2 mL NS (perineural) + 0.1 mg/kg dexamethasone in 100mL NS (Intravenous); Group III: 2mL NS (perineural) + 100mL NS (Intravenous). Total volume given perineurally will be 27ml. Maximum dose of dexamethasone to be used will be 6mg. Random blood sugar will be measured at baseline (T0) and then 2, 4, 8, and 24 hours after T0. Expected Benefits: This study will help us to evaluate the effect of dexamethasone on random blood sugar levels in supraclavicular block when given intravenous vs perineurally. |