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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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
  1. 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).

  2. 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

  3. 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.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [shaila.kamath@manipal.edu].

  6. 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.

  7. 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.

 
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