| CTRI Number |
CTRI/2023/05/052194 [Registered on: 02/05/2023] Trial Registered Prospectively |
| Last Modified On: |
30/04/2023 |
| 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
|
To compare effect of adding drugs like dexamethasone and dexmedetomidine as additives in upper limb nerve block surgeries in reducing Rebound postoperative pain in patients |
|
Scientific Title of Study
|
COMPARISON OF PERINEURAL DEXAMETHASONE AND DEXMEDETOMIDINE AS ADJUVANTS IN REDUCING REBOUND PAIN IN PATIENTS UNDERGOING PERIPHERAL NERVE BLOCK:A DOUBLE BLIND RANDOMISED CONTROLLED STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR ABINAYA K |
| Designation |
POST GRADUATE |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Department of Anesthesiology, Karnataka institute of Medical sciences,vidhya nagar,Hubballi,DHARWAD 580032
Dharwad
KARNATAKA
580032
India |
| Phone |
9344670831 |
| Fax |
|
| Email |
abi.4996@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Professor and HOD |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
and HOD, Department of anaesthesiology, Karnataka institute of medical sciences, Vidhya nagar, Hubballi, Dharwad, Karnataka 580032
Dharwad
KARNATAKA
580032
India |
| Phone |
9449590556 |
| Fax |
|
| Email |
drmadhuri_kurdi@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Madhuri S Kurdi |
| Designation |
Professor and HOD |
| Affiliation |
Karnataka institute of medical sciences |
| Address |
Professor and HOD, department of Anesthesiology, Karnataka institute of medical sciences, vidhya nagar, Hubballi.
Dharwad
KARNATAKA
580032
India |
| Phone |
9449590556 |
| Fax |
|
| Email |
drmadhuri_kurdi@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Karnataka institute of medical sciences, vidhya nagar, Hubballi Dharwad 580032 |
|
|
Primary Sponsor
|
| Name |
Dr Abinaya K |
| Address |
Postgraduate, department of Anesthesiology, Karnataka institute of medical sciences, vidhya nagar, Hubballi, Dharwad |
| Type of Sponsor |
Other [Self] |
|
|
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 Abinaya K |
Karnataka institute of medical sciences |
Department of Anesthesiology, Karnataka institute of medical sciences, vidhya nagar, Hubballi.
Dharwad
KARNATAKA |
9344670831
abi.4996@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Karnataka institute of medical sciences, Hubballi ethics 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 |
| Intervention |
dexamethasone |
To add dexamethasone 2ml(8mg) with 28 ml of 0.75% Ropivacaine given for nerve block by supraclavicular approach once before start of surgery
|
| Intervention |
DEXMEDETOMIDINE |
To add dexmedetomidine 0.5 ml(25 microgram) with 28 ml of 0.75% Ropivacaine given for nerve block by supraclavicular approach once before start of surgery
|
| Comparator Agent |
Not adding any adjuvant |
28 ml of 0.75% Ropivacaine given for nerve block by supraclavicular approach once before start of surgery
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients belonging to ASA physical status 1and 2
2.Patients giving informed valid written consent
3.patients undergoing elective orthopaedic upper limb surgery |
|
| ExclusionCriteria |
| Details |
1.Patients with coagulopathies, neurological disorder
2.Patients having hypersensitivity to any of study drugs |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the rebound pain in three study groups (dexamethasone as adjuvant, dexmedetomidine as adjuvant and no adjuvant added) and compare numerical rating scores |
Rebound pain will be monitored for 48 hours post placement of block |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess time taken for resolution of nerve blocks
|
Assessment of return of motor movement and sensation for 48 hours in the postoperative period |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
05/05/2023 |
| 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="1"
Months="0"
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 is a type of randomised double blind controlled study in which comparison of dexamethasone and dexmedetomidine as adjuvant and adding no adjuvant in reducing Rebound pain in patients undergoing peripheral nerve block of upper limb orthopaedic surgery is done.Totally there are 3 groups,each containing 25 persons and total sample size is 75. |