| CTRI Number |
CTRI/2025/12/098423 [Registered on: 03/12/2025] Trial Registered Prospectively |
| Last Modified On: |
29/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Clinical Trial To Study The Effects Of Two Drugs, Dexamethasone And Dexmedetomidine Given As a Regional Anaesthesia In Patients Undergoing Shoulder Surgeries |
|
Scientific Title of Study
|
Comparative Study Of Dexamethasone And Dexmedteomidine As Adjuvants To 0.5 Percent Ropivacine In Combined Interscalene And Supraclavicular Block For Patients Undergoing Shoulder Surgeries: A Prospective Randomized Controlled Double Blind Study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bharathi Hosdurg |
| Designation |
Senior Consultant |
| Affiliation |
Manipal Hospital Whitefield |
| Address |
First floor, Department of Anesthesia,
Manipal Hospital Whitefield, ITPL Main road, Krishnarajapura Bangalore.
Bangalore
KARNATAKA
560067
India |
| Phone |
9900190920 |
| Fax |
|
| Email |
bharathi.hosdurg@manipalhospitals.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mirnalini A |
| Designation |
DNB resident |
| Affiliation |
MANIPAL HOSPITAL WHITEFIELD |
| Address |
First floor, Department of Anesthesia,
Manipal Hospital Whitefield, ITPL Main road, Krishnarajapura Bangalore.
Bangalore
KARNATAKA
560067
India |
| Phone |
9842015338 |
| Fax |
|
| Email |
mirnuuu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
BHARATHI HOSDURG |
| Designation |
SENIOR CONSULTANT |
| Affiliation |
MANIPAL HOSPITAL WHITEFIELD |
| Address |
First floor, Department of Anesthesia,
Manipal Hospital Whitefield, ITPL Main road, Krishnarajapura Bangalore.
Bangalore
KARNATAKA
560067
India |
| Phone |
9900190920 |
| Fax |
|
| Email |
bharathi.hosdurg@manipalhospitals.com |
|
|
Source of Monetary or Material Support
|
| Manipal Hospital Whitefield, ITPL Main road, Krishnarajapura Bangalore, India. Pincode - 560067. |
|
|
Primary Sponsor
|
| Name |
Manipal Hospital Whitefield |
| Address |
Manipal Hospital 98, HAL old Airport road, Kodihalli, Bangalore, India. Pincode - 560017. |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Bharathi Hosdurg |
Manipal Hospital whitefield |
Departments Of Anaesthesia And Orthopedics, Manipal Hospital Whitefield, ITPL Main Road, Krishnarajapura - 560066
Bangalore
KARNATAKA |
9900190920
bharathi.hosdurg@manipalhospitals.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE OF MANIPAL HOSPITALS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M241||Other articular cartilage disorders, (2) ICD-10 Condition: M621||Other rupture of muscle (nontraumatic), (3) ICD-10 Condition: M620||Separation of muscle (nontraumatic), (4) ICD-10 Condition: M668||Spontaneous rupture of other tendons, (5) ICD-10 Condition: M669||Spontaneous rupture of unspecifiedtendon, (6) ICD-10 Condition: M256||Stiffness of joint, not elsewhereclassified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ropivacaine With Dexamethasone |
28ml Of 0.5% Ropivacaine And 2ml Of Dexamethasone (8 mg) Administered In Combined Interscalene And Supraclavicular Block |
| Intervention |
Ropivacaine With Dexmedetomidine |
28ml Of 0.5% Ropivacaine And 2ml Of Dexmedetomidine (1 microgram/Kg) Administered In Combined Interscalene And Supraclavicular block |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective shoulder surgery under combined interscalene and supraclavicular block
2. Patients classified under American Society of Anesthesiologists physical status I or II classification
|
|
| ExclusionCriteria |
| Details |
1. Patients who choose not to participate in the study.
2. Patients who are allergic to local anaesthetics
3. Pregnant or lactating individuals
4. Patients with bleeding diathesis or those using anticoagulants
5. Patients with history of serious neurological or psychiatric disorders
6. Patients on systemic corticosteroids for at least two weeks or more within six months of surgery
7. Patients with a history of long term opioid or other analgesic consumption
8. Presence Infection or lesion at the site of block |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO COMPARE THE DURATION OF SENSORY BLOCKADE BETWEEN THE DEXAMETHASONE AND DEXMEDETOMIDINE GROUP OF PATIENTS |
Baseline, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration Of Motor Bloackade |
24 Hours |
| Postoperative Analgesic Requirements |
24 Hours |
| Postperative Pain scores |
24 hours |
| Patient Satisfaction Score |
24 Hours |
| Incidence Of Adverse Effects |
24 Hours |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
16/12/2025 |
| 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 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
|
Severe postoperative pain is commonly experienced after shoulder surgeries. Among the various peripheral nerve blocks, brachial plexus block is one of the most commonly practised blocks as it offers near total anaesthesia and analgesia and an excellent operative field for surgeries of the upper extremities. The duration of analgesia is a major limiting factor as the block produced by a single injection of local anaesthetics is not sufficient to prolong the effect of anaesthesia. Hence, the present study aims to compare effects of adding Dexmedetomidine and Dexamethasone to 0.5% Ropivacaine for combined Interscalene and Supraclavicular brachial plexus blocks in upper limb orthopedic surgeries. |