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CTRI Number  CTRI/2023/06/054435 [Registered on: 26/06/2023] Trial Registered Prospectively
Last Modified On: 03/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Dexamethasone or Dexmedetomidine : The better helper for post-operative pain relief in femoral nerve blocks 
Scientific Title of Study   Comparison of post operative analgesic efficacy of dexamethasone with dexmedetomidine as an adjuvant to ropivacaine in ultrasound guided femoral nerve block in unilateral total knee arthroplasty under spinal anaesthesia: a prospective randomized control study  
Trial Acronym  nill 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amolpreet Kaur 
Designation  DNB registrar 
Affiliation  Fortis Hospital Mohali 
Address  Fortis hospital , Mohali

Amritsar
PUNJAB
160062
India 
Phone  9592047004  
Fax    
Email  kauramolpreet@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Suman Shekhawat 
Designation  consultant 
Affiliation  Fortis Hospital Mohali 
Address  anaesthesia department, Fortis hospital , Mohali

Rupnagar
PUNJAB
160062
India 
Phone  7888423534  
Fax    
Email  drsumanshekhawat@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Amolpreet Kaur 
Designation  DNB registrar 
Affiliation  Fortis Hospital Mohali 
Address  anaesthesia department, Fortis hospital , Mohali

Amritsar
PUNJAB
160062
India 
Phone  9592047004  
Fax    
Email  kauramolpreet@gmail.com  
 
Source of Monetary or Material Support  
Fortis hospital. Phase 8, Sector 62, Mohali 160062 
 
Primary Sponsor  
Name  fortis hospital mohali 
Address  Fortis hospital, Sector 62, Phase 8, Mohali, Punjab 
Type of Sponsor  Private hospital/clinic 
 
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 Amolpreet Kaur  Fortis Hospital Mohali  Ortho icu 1, Anaesthesia department
Rupnagar
PUNJAB 
9592047004

kauramolpreet@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, fortis hospital, Mohali  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexamethasone  Monitoring the 24 hour post operative analgesia provided with 8mg Dexamethasone as an adjuvant to 30ml of 0.375% Ropivacaine in femoral nerve block given peri-operatively in patients undergoing unilateral total knee arthroplasty under spinal anesthesia. 
Intervention  Dexmedetomidine  Using Dexmedetomidine in dose of 1mg/kg, as an adjuvant to 30ml of 0.375% Ropivacaine in peri-operative femoral nerve block in patients undergoing unilateral total knee arthroplasty under spinal anesthesia and monitoring the analgesic efficacy in the first 24 hours post operatively. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA 1 and 2
consenting to participate
able to comprehend and coperate
posted for unilateral total knee arthroplasty 
 
ExclusionCriteria 
Details  patient refusal
obese patient BMI >35
ASA 3,4
patients with history of OSA or substance abuse, or chronic opiod use.
allergy to local anaesthetic or any drugs used in trial
contra-indication to spinal anaesthesia or posted under general anaesthesia
patients with hearing or cognitive dysfunction
patients on anticoagulants/ history of bleeding disorders
pre-existing peripheral neuropathoies 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
average VAS score between the two groups within first 24 hours  0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 14 hours, 16 hours, 18 hours,20 hours, 24 hours 
 
Secondary Outcome  
Outcome  TimePoints 
time of first administration of rescue analgesic  within 24 hours 
to measure the total number of opioid boluses required over the first 24 hours post operatively  within 24 hours 
compare the number of patients requiring opioid bolus in the first 24 hours in each group  within 24 hours 
to compare the number of patients amongst each group who report a VAS score of more than or equal to 4 within first 24 hours post operative  0 hours, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 10 hours, 12 hours, 14 hours, 16 hours, 18 hours,20 hours, 24 hours 
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="120" 
Final Enrollment numbers achieved (Total)= "122"
Final Enrollment numbers achieved (India)="122" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   30/06/2023 
Date of Study Completion (India) 02/02/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
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  

This study is a double blind prospective randomized control trial to evaluate the analgesic efficacy of dexamethasone and dexmedetomidine, as an adjuvant to 0.375% ropivacaine in ultrasound guided femoral nerve block. This study will be done on 120 ASA I -II patients undergoing unilateral total knee arthroplasty at of Fortis hospital, Mohali. All eligible and consenting patients will be explained VAS score beforehand and given intrathecal 0.5% heavy bupivacaine (dose in range of 2.8-3.4 ml) along with femoral nerve block. Under no circumstances the dose of bupivacaine will exceed 2mg/kg body weight. Patients will be divided between two groups via computer generated randomisation. For femoral nerve block, Group A will receive 8mg dexamethasone with 30ml of 0.375% ropivacaine and group B will receive 1mcg /kg dexmedetomidine with 30ml of 0.375% ropivacaine. The investigator as well as the patient will be blinded about the drug being used. Post operative VAS score and need for rescue analgesia, will be assessed for 24 hours and compared between the two groups. Any adverse effects will also be reported. Based on existing studies using said adjuvants in femoral nerve block, both dexamethasone and dexmedetomidine have been shown to prolong the duration of block and reduce the requirement of opioids. There is a dearth of studies comparing both adjuvants in femoral nerve block, hence our study aims to fill that gap in knowledge. based on similar studies in other blocks, running hypothesis is that both adjuvants provide adequate analgesia but dexamethasone might prove to have a lower over-all VAS score and requirement for rescue analgesia.

 
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