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CTRI Number  CTRI/2024/07/070587 [Registered on: 15/07/2024] Trial Registered Prospectively
Last Modified On: 13/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Comparative Study 
Study Design  Other 
Public Title of Study   Comparison between 0.25 percent of Bupivacaine and 0.25 percent of Ropivacaine with Dexamethasone in ultrasound guided femoral nerve block for post operative analgesia after total knee arthroplasty 
Scientific Title of Study   Comparison between 0.25 percent of Bupivacaine and 0.25 percent of Ropivacaine with Dexamethasone in ultrasound guided femoral nerve block for post operative analgesia after total knee arthroplasty 
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 Angela Abraham 
Designation  Postgraduate 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Anaesthesia KMC Mangalore Dakshina Kanada Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9868287935  
Fax    
Email  angela.kmcmlr2022@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Dr Ranjan Rao 
Designation  Professor 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Anaesthesia KMC Mangalore Dakshina Kanada Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9449837154  
Fax    
Email  drranjanrao@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Angela Abraham 
Designation  Postgraduate 
Affiliation  Kasturba Medical College, Mangalore 
Address  Department of Anaesthesia KMC Mangalore Dakshina Kanada Karnataka

Dakshina Kannada
KARNATAKA
575001
India 
Phone  9868287935  
Fax    
Email  angela.kmcmlr2022@learner.manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Medical CollegeLight House Hill Road, Mangalore 575001 
 
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 Rajan Rao  Kasturba Medical College, Mangalore  Department of Anaesthesiology Kasturba Medical College, Light House Hill road, Mangalore-575001
Dakshina Kannada
KARNATAKA 
9449837154

drranjanrao@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institution 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 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  The patients undergoing total knee arthroplasty under regional anesthesia.
The patient falling in American society of anaesthesiology grade I ,II and III.
Age 30-80 yrs
 
 
ExclusionCriteria 
Details  Patients who are not willing to participate in the study.
Patient with a history of allergy to the drugs used in the study.Patients with infection at the site of subarachnoid block or femoral nerve block.
Patients with pre-existing peripheral neuropathy.
Patients with impaired renal and liver function, coagulopathy.
Patients with documented history of opioid sensitivity and/or allergy to NSAIDs. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Duration of action of block
2.First time rescue analgesics consumed
3.Total amount of rescue analgesia consumed
4.Time taken for ambulation post surgery
 
To assess motor blockade and VAS score after 30minutes, 1hour,2hours postoperatively
 
 
Secondary Outcome  
Outcome  TimePoints 
To assess duration taken for ambulation of patient postoperatively.
 
After 12hours, 24hours 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   29/07/2024 
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="0"
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  

Total knee replacement (TKR) is associated with significant postoperative pain. This postoperative pain is difficult to treat with oral analgesics, resulting in adverse endocrine, metabolic, and inflammatory responses . Single-injection femoral nerve block (FNB) significantly improves postoperative analgesia compared with systemic opioid therapy at least during the first 24 hours after TKR or ACL reconstruction  although some studies show a limited benefit of single-injection FNB as an analgesic technique during TKR or ACL reconstruction. The pain after TKA is severe and does not fade noticeably for 48–72 h after the surgery. Effective pain control allows for earlier ambulation and initiation of physiotherapy, which hastens recovery, A reduces the length of stay in the hospital, and lowers the risk of postoperative complications, such as thromboembolic dis- ease or nosocomial infections. Bupivacaine is the standard, long-acting local anaesthetic used in regional anaesthetic practice together with ropivacaine, a N-propyl homologue of bupivacaine and a pure S(-) enantiomer . Ropivacaine has shown a reduced potential for central nervous system toxicity and cardiotoxicity in laboratory experiments and in healthy volunteers . Total knee replacement (TKR) is associated with significant postoperative pain. This postoperative pain is difficult to treat with oral analgesics, resulting in adverse endocrine, metabolic, and inflammatory responses . Single-injection femoral nerve block (FNB) significantly improves postoperative analgesia compared with systemic opioid therapy at least during the first 24 hours after TKR or ACL reconstruction  although some studies show a limited benefit of single-injection FNB as an analgesic technique during TKR or ACL reconstruction.  The pain after TKA is severe and does not fade noticeably for 48–72 h after the surgery. Effective pain control allows for earlier ambulation and initiation of physiotherapy, which hastens recovery, A reduces the length of stay in the hospital, and lowers the risk of postoperative complications, such as thromboembolic disease or nosocomial infections. Bupivacaine is the standard, long-acting local anaesthetic used in regional anaesthetic practice together with ropivacaine, a N-propyl homologue of bupivacaine and a pure S(-) enantiomer . Ropivacaine has shown a reduced potential for central nervous system toxicity and cardiotoxicity in laboratory experiments and in healthy volunteersDexamethasone added to local anaesthetics (LAs) appears to prolong single-injection nerve block. The analgesic effects of spinal and systemic corticosteroids combined with LAs have proven to be effective in humans, whereas dexamethasone microspheres have increased block duration .

The purpose of the study is to compare difference in post operative analgesic duration, amount of sedation and systemic side effects in 0.25%bupivacaine and 4mg dexamethasone with 0.25% ropivacaine and adjuvant 4mg dexamethasone using femoral nerve block as a post operative analgesia in TKR

 
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