| CTRI Number |
CTRI/2023/10/059111 [Registered on: 25/10/2023] Trial Registered Prospectively |
| Last Modified On: |
31/08/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
study to find out the efficacy of 0.75% ropivacaine alone or with dexmedetomidine in upper limb suregries. |
|
Scientific Title of Study
|
A Comparative study to evaluate the efficacy of 0.75% Ropivacaine alone or combined with dexmedetomidine in supraclavicular brachial plexus block in upper limb surgeries. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR KAJAL |
| Designation |
pg student |
| Affiliation |
MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA |
| Address |
MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA HISAR
Hisar
HARYANA
125047
India |
| Phone |
9717228629 |
| Fax |
|
| Email |
kajalyaduvanshi30@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SUMITRA KANOJIYA |
| Designation |
PROFESSOR |
| Affiliation |
MAHARAJA GRASEN MEDICAL COLLEGE,AGROHA. |
| Address |
MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA
Hisar
HARYANA
125047
India |
| Phone |
8307994393 |
| Fax |
|
| Email |
DRSUMITRAKANOJIYA@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
DR SUMITRA KANOJIYA |
| Designation |
PROFESSOR |
| Affiliation |
MAHARAJA GRASEN MEDICAL COLLEGE,AGROHA. |
| Address |
MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA
HARYANA
125047
India |
| Phone |
8307994393 |
| Fax |
|
| Email |
DRSUMITRAKANOJIYA@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
| DEPARTMENT OF ANESTHESIA. MAHARAJA AGRASEN MEDICAL COLLEGE AGROHA HISAR |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia |
| Address |
OT Complex DEPARTMENT OF ANESTHESIA MAHARAJA AGRASEN MEDICAL COLLEGE Aroha Hisar |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| DR KAJAL |
Department of Anesthesia MAHARAJA AGRASEN MEDICAL COLLEGE Agroha Hisar |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR KAJAL |
MAHARAJA AGRASEN MEDICAL COLLEGE |
OT Complex Department of Anesthesiology and Critical Care.
Hisar
HARYANA |
9717228629
kajalyaduvanshi30@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTE FOR HUMAN RESEARCH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M859||Disorder of bone density and structure, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.75% ROPIVACAINE |
Ropivacaine is an aminoamide local anesthetic drug. It is indicated in adult patients for the induction of regional or local anesthesia for surgery or acute pain management. The median onset of sensory block produced by ropivacaine 0.5% range from 10 min-45min. median duration range from (route and dose dependent) 3.7hrs to 8.7hrs. Ropivacaine undergoes extensive metabolism, primarily via CYP1A2- mediated aromatic hydroxylation to 3-OH- ropivacaine. Following intravenous administration, 86% of the administered dose of ropivacaine is excreted in the urine, 1% of which comprises unchanged parent drug. When performing major nerve blocks, the dosages are 35 to 50 mL of 0.5% solution and 10 to 40 mL of 0.75% solution. |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine is a highly selective α2-adrenergic agonist. It is a sympatholytic drug that acts as an agonist of α2-adrenergic receptors in certain part of the brain. Dexmedetomidine, an imidazole compound, dextro-isomer of medetomidine, displays specific and selective α2- adrenoceptor agonist. Dexmedetomidine may act on supraspinal (locus coeruleus) or spinal level or peripheral α2-adrenoreceptor to reduce nociceptive transmission, leading to analgesia. In various human studies, dexmedetomidine has been reported to enhance sensory and motor block along with increased duration of analgesia. Dexmedetomidine induces sedation by decreasing activity of noradrenergic neurons in the locus ceruleus in the brain stem, thereby increasing the downstream activity of inhibitory gamma-aminobutyric acid (GABA) neurons in the ventrolateral preoptic nucleus. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
120 patients of either sex, aged 18—60 years, belonging to American Society of Anesthesiologists (ASA) physical status class I and Il presenting for upper limb elective surgery under supraclavicular block. |
|
| ExclusionCriteria |
| Details |
Who refuse to give consent.
With severe cardiac, renal, endocrine, pulmonary disease.
In physical status ASA grade Ill or higher.
Who are allergic to trial drugs.
Who are having local site infection.
With hemi-diaphragmatic paralysis on opposite side of surgery
With any psychological disorder who would interfere with assessment of pain.
With history of brachial plexus injury.
With bilateral upper limb surgery and fracture.
With heart rate already on the lower side i.e 55 or less than 55b/m.
|
|
|
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 determine whether the efficacy of 0.75% Ropivacaine with
dexmedetomidine is greater than 0.75% Ropivacaine used alone in supraclavicular brachial plexus block for upper limb surgeries.
|
Onset & duration of Sensory block. Onset and duration of motor block. Duration of analgesia.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the Hemodynamic parameters Complications.
|
To compare the Hemodynamic parameters Complications.
|
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
12/09/2024 |
| 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)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kajalyaduvanshi30@yahoo.com].
- For how long will this data be available start date provided 31-08-2023 and end date provided 20-01-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
it is a study to compare analgesic efficacy and motor blockade of 0.75% ropivacaine used alone or in combination with dexmedetomidine in upper limb surgeries. |