| CTRI Number |
CTRI/2021/03/031994 [Registered on: 15/03/2021] Trial Registered Prospectively |
| Last Modified On: |
13/03/2021 |
| 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 Dexamethasone and ketamine for postoperative analgesia when aded as adjuvant to 0.2% ropivacaine in infraclavicular brachial plexus block. |
|
Scientific Title of Study
|
Comparison between Dexamethasone and ketamine as adjuvant to 0.2% ropivacaine for postoperative analgesia with ultrasound guided infraclavicular brachial plexus block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Fathima Sufeera |
| Designation |
Junior resident, government medical college Calicut, department of anaesthesiology |
| Affiliation |
Government medical college Calicut |
| Address |
Department of anaesthesiology
Department of anaesthesiology
Kozhikode
KERALA
673008
India |
| Phone |
8547758929 |
| Fax |
|
| Email |
kalakkalsufeera@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr KrishnadasA |
| Designation |
Associate professor |
| Affiliation |
Government medical college Calicut |
| Address |
Department of anaesthesiology
Government medical college
Kozhikode
Department of anaesthesiology
Government medical college
Kozhikode
Kozhikode
KERALA
673008
India |
| Phone |
9447382969 |
| Fax |
|
| Email |
drakrishnadas@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Fathima Sufeera |
| Designation |
Junior resident, government medical college Calicut, department of anaesthesiology |
| Affiliation |
Government medical college Calicut |
| Address |
Department of anaesthesiology
2019 batch
Department of anaesthesiology
Kozhikode
KERALA
673008
India |
| Phone |
8547758929 |
| Fax |
|
| Email |
kalakkalsufeera@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college Calicut |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Not applicable] |
|
|
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 |
| Fathima sufeera |
Government medical college Calicut |
Government medical college Calicut
Department of anaesthesiology
Kozhikode
KERALA |
8547758929
kalakkalsufeera@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Government medical college Kozhikode |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M849||Disorder of continuity of bone, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adding dexamethasone as adjuvant to 0.2% ropivacaine |
For postoperative analgesia |
| Comparator Agent |
Adding ketamine to 0.2% ropivacaine |
For postoperative analgesia |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA1and2, undergoing elective below elbow/ forearm surgery |
|
| ExclusionCriteria |
| Details |
Age <18 yr and >60 year
ASA>2
Patient with systemic disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative analgesia or time taken for first rescue analgesia |
24 hour post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative pain score by numerical rating score
Total rescue analgesia consumption
Haemodynamics in the form of HR, systolic diastolic and mean arterial blood pressure, oxygen saturation |
First 24 hour |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
20/03/2021 |
| 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="6"
Days="1" |
|
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
|
In this study, the patient will be grouped into two by computer generated random number chart, numbers will be written on 100 concealed envelopes half of which are marked Group K and rest as Group D. Group K_ ketamine group ang group D dexamethasone group. Patients are given general anesthesia with supraglottic airway device, then performing infraclavicular brachial plexus block under usg guidelines. Intraoperative vitals are monitored including mean arterial blood pressure, heart rate, spo2. Post operative pain assessed using a 10 cm numerical rating score (NRS) and recorded at admission to post operative care unit and 1,2,4,6,8,12,&24 hr postoperative. . |