| CTRI Number |
CTRI/2024/08/072515 [Registered on: 14/08/2024] Trial Registered Prospectively |
| Last Modified On: |
06/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of effects of Dexmedetomidine and Dexamethasone with Ropivacaine in Regional Anaesthesia in Upper Limb Surgeries. |
|
Scientific Title of Study
|
Comparison of Dexmedetomidine and Dexamethasone used as an Adjuvant to Ropivacaine in Ultrasound-Guided 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 Umesh N P |
| Designation |
Associate professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology,
Mandya institute of Medical Sciences,Mandya-571401
Mandya
KARNATAKA
571401
India |
| Phone |
9886645947 |
| Fax |
|
| Email |
drumeshnp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Umesh N P |
| Designation |
Associate professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology,
Mandya institute of Medical Sciences,Mandya-571401
Mandya
KARNATAKA
571401
India |
| Phone |
9886645947 |
| Fax |
|
| Email |
drumeshnp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Umesh N P |
| Designation |
Associate professor |
| Affiliation |
Mandya institute of medical sciences |
| Address |
Department of Anaesthesiology,
Mandya institute of Medical Sciences,Mandya-571401
Mandya
KARNATAKA
571401
India |
| Phone |
9886645947 |
| Fax |
|
| Email |
drumeshnp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Major Operation Theatre,
Mandya Institute of Medical Sciences,
Mandya-571401 |
|
|
Primary Sponsor
|
| Name |
Dr Umesh N P |
| Address |
Associate Professor,
Department of Anaesthesiology,
Mandya institute of Medical Sciences,
Mandya-571401 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Arunkumaran D |
Post Graduate Student,
Department of Anaesthesiology,
Mandya Institute of Medical Sciences. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Arunkumaran D |
Mandya institute of medical sciences |
Department of Anaesthesiology,
Mandya Institute of Medical Sciences,
Mandya-571401
Mandya
KARNATAKA |
8951344252
darunkumaran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MANDYA INSTITUTE OF MEDICAL SCIENCES;INSTITUTION ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M95-M95||Other disorders of the musculoskeletal system and connective tissue, (2) ICD-10 Condition: M958||Other specified acquired deformities of musculoskeletal system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
DEXAMETHASONE WITH ROPIVACAINE |
IN THIS GROUP PATIENTS WILL RECEIVE 30ml OF 0.5% ROPIVACAINE CONTAINING 8mg DEXAMETHASONE IN USG GUIDED SUPRACLAVICULAR BRACHIAL PLEXUX BLOCK.PATIENTS WILL BE OBSERVED FOR 24 HOURS |
| Intervention |
DEXMEDETOMIDINE WITH ROPIVACAINE |
IN THIS GROUP PATIENTS WILL RECEIVE 30ml OF 0.5% ROPIVACAINE CONTAINING 1mcg/kg DEXMEDITOMIDINE IN USG GUIDED SUPRACLAVICULAR BRACHIAL PLEXUX BLOCK.PATIENTS WILL BE OBSERVED FOR 24 HOURS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of both sexes aged ≥18 yrs.
2.Patients undergoing elective upper limb surgeries.
3.ASA-PS I and II patients.
4.Patients who are willing to participate in the study with informed consent.
|
|
| ExclusionCriteria |
| Details |
1.Infection at site of injection.
2.Patients who have peripheral neuropathy.
3.Presence of 1st,2nd and 3rd degree heart block.
4.Patients who are pregnant.
5.Patients who have coagulopathies.
6.Patients who have allergy or hypersensitivity to local anaesthetic drugs. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the onset and duration of motor and sensory block between dexmedetomidine and dexamethasone as an adjuvant to ropivacaine in ultrasound-guided supraclavicular brachial plexus block. |
24 HOURS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the sedation during intraoperative period.
2.To compare the duration of analgesia in post operative period.
3.Side effects such as vomiting,pruritus,local anaesthetic associated systemic toxicity. |
24 hrs |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
20/08/2024 |
| 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
|
Study is initiated to compare the onset and duration of motor and sensory block between dexmedetomidine and dexamethasone as an adjuvant to ropivacaine in ultrasound guided supraclavicular brachial plexus block will be assesed and recorded and to compare the sedation, duration of analgesia, side effects during the study |