| CTRI Number |
CTRI/2024/09/074147 [Registered on: 23/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Other |
|
Public Title of Study
|
A Study on post operative pain management in patients undergoing Total Knee Replacement |
|
Scientific Title of Study
|
Effect of Intravenous Dexmedetomidine in patients undergoing Total Knee Arthroplasty on post operative analgesic requirement |
| 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 Nadupalli Priyanka |
| Designation |
postgraduate |
| Affiliation |
kasturba medical college, mangalore |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Light House Hill Road, Mangalore
Dakshina kannada
Karnataka
575001
India
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9676927472 |
| Fax |
|
| Email |
priyanka.nadupalli@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shaila S Kamath |
| Designation |
Professor |
| Affiliation |
kasturba medical college, mangalore |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Light House Hill Road, Mangalore
Dakshina kannada
Karnataka
575001
India
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9844090231 |
| Fax |
|
| Email |
shaila.kamath@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Shaila S Kamath |
| Designation |
Professor |
| Affiliation |
kasturba medical college, mangalore |
| Address |
Department of Anaesthesiology, Kasturba Medical College, Light House Hill Road, Mangalore
Dakshina kannada
Karnataka
575001
India
Dakshina Kannada KARNATAKA 575001 India |
| Phone |
9844090231 |
| Fax |
|
| Email |
shaila.kamath@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Light House Hill Road, Mangalore 575001
karnataka
India |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
Light House Hill Road, Mangalore
575001 |
| Type of Sponsor |
Private medical college |
|
|
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 Nadupalli Priyanka |
Kasturba Medical College Hospital |
Department of Anaesthesiology, Kasturba Medical College, Light House Hill Road, Mangalore Dakshina Kannada KARNATAKA |
9676927472
priyanka.nadupalli@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College, Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M179||Osteoarthritis of knee, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control (Group C) |
Total Participants: 25
This group of patients undergoing unilateral total knee replacement under spinal anaesthesia will not receive dexemedetomidine. |
| Comparator Agent |
Dexmedetomidine (Group D) |
Total participants: 25
Injection Dexmedetomidine intravenous infusion will be given to patients undergoing unilateral total knee replacement under spinal anaesthesia.10 minutes after spinal anaesthesia is given, Injection Dexmedetomidine intravenous infusion of 0.5mcg/kg/hr is started and continued till skin closure. |
|
|
Inclusion Criteria
|
| Age From |
55.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults aged 55-80 years.
2. Patients with ASA-PS I and II.
3. Unilateral total knee replacement. |
|
| ExclusionCriteria |
| Details |
1.Not willing to participate in the study
2.ASA-PS III and above
3.Patients with severe pulmonary, hepatic, cardiac or renal disease
4.Total Knee Replacement under general anaesthesia
5.History of any drug allergies.
6.Psychiatric illness
7.Patients with an abnormal coagulation profile
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Post operative anlagesic requirement |
0,2,4,6,12 and 24 hours post surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Hemodynamic variables
2.Time of supplementation of first rescue analgesia
3.Total intraoperavtive blood loss calculation |
preoperative,intraoperative and 24 hours postoperative period |
|
|
Target Sample Size
|
Total Sample Size="50" Sample Size from India="50"
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)
|
23/09/2024 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 Response - Analytic Code
- 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 [shaila.kamath@manipal.edu].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2031?
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
|
Pain, either acute or chronic, is one of the
most common reasons why patients seek medical help. Pain is a multifactorial
and complex process that is defined as ‘‘an unpleasant sensory and emotional
experience associated with actual or potential tissue damage†. A
prospective cohort study was conducted in Germany comparing 179 surgical
procedures in 50,523 patients, which showed that the 40 procedures with the highest
pain scores included 22 orthopaedic procedures on the extremities. Patients
who undergo Total knee arthroplasty (TKA) are associated with a significant postoperative
pain which sometimes can be underemphasized. This in turn affects
the recovery of the patient, early mobilization and rehabilitation.
Therefore, an adequate approach for pain management is extremely important to
reduce the morbidity and improve recovery.
Many drugs have been used to provide
adequate and effective post operative analgesia, including local anesthetics
such as lidocaine and bupivacaine, opioids such as morphine and α2-
adrenergic receptor agonists such as clonidine. However, none of
these agents are free from limitations such as the need for special equipment
and monitoring or the risk of complications which may cause a delay in the
discharge process.
Dexmedetomidine is a highly selective,
specific, and potent α2-adrenergic receptor agonist. It possesses
anxiolytic, sedative, analgesic and sympatholytic properties. Many
studies have demonstrated that dexmedetomidine can significantly decrease pain
scores and postoperative diclofenac sodium, major opioid consumption and can
improve the duration of the analgesic effect in patients undergoing knee
arthroscopy. Furthermore, the incidence of postoperative
delirium and postoperative nausea and vomiting (PONV) decreases with the use of dexmedetomidine therapy. It has also been shown that
dexmedetomidine prolonged the duration of spinal anaestheisa and improved post-surgical
analgesia.
This study aims to evaluate the analgesic
effect of intravenous dexmedetomidine and its effectiveness in reducing the
postoperative consumption of non-steroidal anti-inflammatory drugs and opioid
analgesics. |