| CTRI Number |
CTRI/2025/02/081248 [Registered on: 24/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Dexmedetomidine And Dexamethasone As An Adjuvant To Ropivacaine 0.5 Percentage In Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries: A Randomised Clinical Trial |
|
Scientific Title of Study
|
Comparison Of Dexmedetomidine And Dexamethasone As An Adjuvant To Ropivacaine 0.5 Percentage In Ultrasound Guided Supraclavicular Brachial Plexus Block In Patients Undergoing Upper Limb Surgeries: A Randomised Clinical Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Arivumadhi Sankar |
| Designation |
Post Graduate Trainee-1st year |
| Affiliation |
Regional Institute of Medical Sciences |
| Address |
Department of Anaesthesiology, Regional institute of medical science,Imphal
Imphal West MANIPUR 795004 India |
| Phone |
8667647189 |
| Fax |
|
| Email |
arivumadhisankar@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
L Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional institute of medical sciences, Imphal West, Manipur |
| Address |
Department of Anaesthesiology, Regional institute of medical sciences, Imphal West, Manipur.
Imphal West MANIPUR 795004 India |
| Phone |
7005238251 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
L Pradipkumar Singh |
| Designation |
Professor |
| Affiliation |
Regional institute of medical sciences, Imphal West, Manipur |
| Address |
Department of Anaesthesiology, Regional institute of medical sciences, Imphal West, Manipur.
Imphal West MANIPUR 795004 India |
| Phone |
7005238251 |
| Fax |
|
| Email |
drlaithangba@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal, Manipur, India.
795004 |
|
|
Primary Sponsor
|
| Name |
Arivumadhi Sankar |
| Address |
Regional Institute of Medical Sciences, Imphal, Manipur |
| 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 Arivumadhi Sankar |
Regional Institute of Medical Sciences |
Elective surgery operation theatre complex(OT 1-8), Department of Anaesthesiology, Regional Institute of Medical Sciences, Imphal West, Manipur, India - 795004 Imphal West MANIPUR |
8667647189
arivumadhisankar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, Regional Institute of Medical Sciences, Imphal, Manipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S424||Fracture of lower end of humerus, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
0.5 percentage Ropivacaine and Dexamethasone |
Study participants will be randomized into two groups. Intervention group receiving 0.5% ropivacaine with dexamethasone as adjuvant in ultrasound guided supraclavicular brachial plexus block in patients undergoing upper limb surgeries. |
| Comparator Agent |
0.5 percentage Ropivacaine and Dexmedetomidine |
Study participants will be randomized into two groups. Comparator group receiving 0.5% ropivacaine with dexmedetomidine as adjuvant in ultrasound guided supraclavicular brachial plexus block in patients undergoing upper limb surgeries. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of age group 18 to 60 years.
2. Patients of American Society of Anaesthesiologists (ASA) physical status grade I or II. |
|
| ExclusionCriteria |
| Details |
1. Patients with hypertension, diabetes mellitus, autonomic neuropathy, peripheral nerve injury
2. Pregnancy or lactation.
3. Patients on anticoagulants or bleeding disorders.
4. Patients with hypersensitivy to amide group of local anaesthetic agents and dexmedetomidine.
5. Uncooperative/unwilling patients.
6. Local site infection. |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Onset and duration of sensory and motor block (using HOLLMEN SCALE) using 0.5% Ropivacaine and dexmedetomidine as adjuvant |
Baseline and time when patient complains of pain and can start moving his limbs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Onset & duration of sensory & motor block (using HOLLMEN SCALE) using 0.5% ropivacaine & dexamethasone as adjuvant |
Baseline & time taken for patient to feel pain & move limbs |
|
|
Target Sample Size
|
Total Sample Size="52" Sample Size from India="52"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/03/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Regional anesthesia techniques have advantages including excellent pain control, reduced side- effects, and shortened stay in the post anesthesia care unit. Ultrasound-guided regional blocks are considered safer with better success rates. Supraclavicular block has high efficacy for providing anaesthesia in upper limb surgeries. Ropivacaine with lesser cardiac side effects is the preferred local anaesthetic agent. Dexmedetomidine and Dexamethasone is used to reduce the onset time, prolong the analgesic, and motor blockade effect without the systemic side effects and reduce total dose of local anesthetic requirement. Here, in our study we determine the duration of analgesia and compare the hemodynamic parameters with two different drugs of Dexmedetomidine and Dexamethasone with 0.5% Ropivacaine. We also try to find any adverse reaction to the study drugs. A total of 52 patients undergoing upper limb surgeries will be divided into two groups: Group A and Group B by block randomization. Group D will receive 20 ml of 0.5% Ropivacaine with 2 ml of 20 mcg Dexmedetomidine and Group X will receive 20 ml of 0.5% Ropivacaine with 2 ml of 8mg Dexamethasone. Duration of analgesia, onset of sensory and motor block, time requirement of rescue analgesia will be studied. Hemodynamic parameters and adverse effects will be recorded. The findings and observations made during the entire study will be tabulated, graphically depicted whenever possible, statistically analyzed and inference will be drawn. |