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CTRI Number  CTRI/2023/06/053586 [Registered on: 06/06/2023] Trial Registered Prospectively
Last Modified On: 05/06/2023
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   A comparative study of combined perineural Dexamethasone and Dexmedetomidine versus perineural Dexamethasone alone as adjuvants to Ropivacaine in adductor canal block for postoperative analgesia in patients undergoing total knee arthroplasty.  
Scientific Title of Study   A randomized prospective comparative study of combined perineural Dexamethasone and Dexmedetomidine versus perineural Dexamethasone alone as adjuvants to Ropivacaine in adductor canal block for postoperative analgesia in patients undergoing total knee arthroplasty under subarachnoid block  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ravi Kant 
Designation  Post MBBS DNB Trainee 
Affiliation  Tata Main Hospital 
Address  TMH Doctors Hostel, straight mile road, bh area, kadma, jamshedpur, Jharkhand

Purbi Singhbhum
JHARKHAND
831001
India 
Phone  8250308598  
Fax    
Email  ravi_doc34@ymail.com  
 
Details of Contact Person
Scientific Query  
Name  Bhanu Pratap Swain  
Designation  DA, DNB, Consultant 
Affiliation  Tata Main Hospital 
Address  Department of Anesthesiology, Tata Main Hospital, Bistupur, jamshedpur, Purbi Singhbhum, Jharkhand

Purbi Singhbhum
JHARKHAND
831001
India 
Phone  8250308598  
Fax    
Email  bhanu.swain@tatasteel.com  
 
Details of Contact Person
Public Query  
Name  Ravi Kant 
Designation  DNB Trainee 
Affiliation  Tata Main Hospital 
Address  TMH Doctors Hostel, straight mile road, bh area, kadma, jamshedpur, Jharkhand

Purbi Singhbhum
JHARKHAND
831005
India 
Phone  8250308598  
Fax    
Email  ravi_doc34@ymail.com  
 
Source of Monetary or Material Support  
Tata Main Hospital, Jamshedpur 
 
Primary Sponsor  
Name  Tata Main Hospital 
Address  C Road West Northern Town, Bistupur, Jamshedpur, jharkhand, 831001 
Type of Sponsor  Research institution and hospital 
 
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 
Ravi Kant  Tata Main Hospital  Department of Anesthesiology, 2nd floor JGMH building, Tata Main Hospital C Road west, Northern Town, Bistupur, Jamshedpur
Purbi Singhbhum
JHARKHAND 		 8250308598

ravi_doc34@ymail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Tata Main Hospital, Jamshedpur  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  Adductor canal block, Ropivacaine, Dexamethasone  Ultrasound guided adductor canal block with 30 ml of 0.5% Ropivacaine along with Dexamethasone 4 mg after completion of surgery 
Intervention  Adductor canal block, Ropivacaine, Dexamethasone, Dexmedetomidine  Ultrasound guided adductor canal block with 30 ml of 0.5% Ropivacaine along with Dexamethasone 4 mg & Dexmedetomidine 50 mcg after completion of surgery  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients undergoing elective primary unilateral total knee arthroplasty under subarachnoid block

ASA grades I-III
 
 
ExclusionCriteria 
Details  Patients refusing to participate in the study

History of allergy to local anesthetics

Patients with coagulopathy or infection at the site of block

Patients with psychiatric illness or cognitive dysfunction who cannot use the patient-controlled analgesia (PCA)

Patients having neuromuscular deficits, severe COPD, renal deficiency, severely compromised cardiovascular status

Patients with body mass index (BMI) of > 35 kg/m2
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Total opioid (Morphine) consumption in the first 24 hours postoperatively  Total opioid (Morphine) consumption in the first 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Opioid (Morphine) consumption   At 48 hours postoperatively 
NRS pain scores  At 3, 6, 12, 18, 24, 30, 36, 42 and 48 hours postoperatively, both at rest and with movement  
Time to first requirement of rescue analgesia
 		 Not Applicable 
Episodes of hypotension, bradycardia and desaturation
 		 In the first 48 hours postoperatively 
Quadriceps muscle strength assessment by Manual Muscle Testing score (MMT)
 		 At 24 and 48 hours postoperatively 
Functional outcome by TUG test (in seconds)   At 48 hours postoperatively
 
Ramsay sedation score
 		 at 3, 6, 12, 18, 24, 20, 36, 42 and 48 hours postoperatively 
 
Target Sample Size   Total Sample Size="58"
Sample Size from India="58" 
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)   16/06/2023 
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 Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   This study is planned to evaluate the potential synergistic effect of dexamethasone and dexmedetomidine, which could have a substantial impact on postoperative analgesia for patients undergoing total knee arthroplasty. We hypothesize that combined perineural dexamethasone and dexmedetomidine as adjuvants to a local anesthetic mixture (Ropivacaine) will provide better postoperative analgesia than perineural dexamethasone alone with local anesthetics used in adductor canal block administered to patients undergoing total knee arthroplasty. 
Fifty-eight patients undergoing unilateral total knee arthroplasty under subarachnoid block shall be randomly divided into 2 groups (DDR & DR) of 29 patients each. Subarachnoid block shall be administered with 3 ml 0.5% heavy Bupivacaine at L3-L4 interspace in the sitting position in either group for anesthesia.  Group DDR Patients shall receive ultrasound-guided adductor canal block with 30 ml of 0.5% Ropivacaine along with  Dexamethasone 4 mg & Dexmedetomidine 50 mcg after completion of surgery. Group DR  patients shall receive ultrasound-guided adductor canal block with 30 ml of 0.5% Ropivacaine along with  Dexamethasone 4 mg and 0.5 ml of saline after completion of the surgery. The postoperative rescue analgesia will consist of Morphine PCA (Patient Controlled Analgesia). PCA setup shall be a bolus of 1 mcg with a lockout interval of 10 mins without any background infusion (maximum dose of 6 mg/h). PCA will be started on shifting the patient to the post-anesthesia care unit (PACU) and will be continued for a period of 48 h post-op. As a part of the multimodal analgesia regime, all patients will receive Paracetamol 1 gm intravenously (8 hourly) and Diclofenac 75 mg intravenous infusion (12 hourly) in the perioperative period. 
 
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