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CTRI Number  CTRI/2022/11/047318 [Registered on: 15/11/2022] Trial Registered Prospectively
Last Modified On: 14/11/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Other 
Public Title of Study   To compare which of the two nerve blocks is better in decreasing pain after total knee replacement surgery- adductor canal nerve block alone or adductor canal nerve block and genicular nerve block combined. 
Scientific Title of Study   Analgesic efficacy of ultrasound-guided genicular nerve block in combination with adductor canal block: a randomized, double-blind, placebo-controlled trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Prateek Mitra 
Designation  Post graduate trainee 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneshwar Khorda ODISHA 751024 India
Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneshwar Khorda ODISHA 751024 India
Khordha
ORISSA
751024
India 
Phone  9776427546  
Fax    
Email  prateek.mitra@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ganesh Chandra Satapathy 
Designation  Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneshwar Khorda ODISHA 751024
Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneshwar Khorda ODISHA 751024
Khordha
ORISSA
751024
India 
Phone  8283872939  
Fax    
Email  Ganesh.satapathy@kims.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Ganesh Chandra Satapathy 
Designation  Professor 
Affiliation  Kalinga Institute of Medical Sciences 
Address  Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneshwar Khorda ODISHA 751024
Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneshwar Khorda ODISHA 751024
Khordha
ORISSA
751024
India 
Phone  8283872939  
Fax    
Email  Ganesh.satapathy@kims.ac.in  
 
Source of Monetary or Material Support  
KALINGA INSTITUTE OF MEDICAL SCIENCES Kushabhadra Campus, 5, KIIT Road, Bhubaneswar, Odisha 751024 
 
Primary Sponsor  
Name  Dr Prateek Mitra 
Address  Department of Anaesthesiology, 3rd floor, PBMH, KIMS, KIIT University, Bhubaneshwar Khorda ODISHA 751024 India 
Type of Sponsor  Other [SELF FUNDED] 
 
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 Ganesh Chandra Satapathy  PRADYUMNA BAL MEMORIAL HOSPITAL, KALINGA INSTITUTE OF MEDICAL SCIENCES   Department of Anesthesiology,3rd floor Ot complex
Khordha
ORISSA 		 8283872939

ganesh.satapathy@kims.ac.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  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 
Intervention  Bupivacaine, 0.25% Ropivacaine, Dexamethasone, Paracetamol, Celecoxib, Morphine  Group I: BLOCK GROUP - Adductor canal block+ genicular block – Ultrasound- guided adductor canal block with 20ml of 0.25% ropivacaine + 4mg (1ml) dexamethasone and USG guided genicular nerve block of superomedial, superolateral and inferomedial genicular nerves with 15ml of 0.25% ropivacaine + 2mg of dexamethasone (5ml each). Patients shall receive Tab PCM 1 gram and Tab celecoxib 200 MG 2 hours prior to surgery. Spinal anaesthesia will be given using 2-3 ml (10-15 mg) of bupivacaine (heavy) 0.5% with a 25‑gauge Quincke’s needle. Additional analgesia will be provided in the form of 1‑gm IV paracetamol and diclofenac 75mg IV at the end of the surgery. Postoperative analgesia will be provided with Tab PCM 1 gm every 8 hourly and Tab celecoxib 200mg 12 hourly. The patients shall be provided with intravenous patient-controlled analgesia (IVPCA) devices (morphine 1 mg/mL) and will be directed to use them by pushing the button when they feel necessary. The devices will be set to a maximum dose of 24 mg of morphine per day. 
Comparator Agent  Bupivacaine, 0.25% Ropivacaine, Dexamethasone, Paracetamol, Celecoxib, Morphine, 0.9% normal saline  Group II: SHAM GROUP - Adductor canal block+ genicular block- Ultrasound- guided adductor canal block with 20ml of 0.25% ropivacaine + 4mg (1ml) dexamethasone and USG guided genicular nerve block of superomedial, superolateral and inferomedial genicular nerves with 15ml of 0.9% saline (5ml each). Patients shall receive Tab PCM 1 gram and Tab celecoxib 200 MG 2 hours prior to surgery. Spinal anaesthesia will be given using 2-3 ml (10-15 mg) of bupivacaine (heavy) 0.5% with a 25‑gauge Quincke’s needle. Additional analgesia will be provided in the form of 1‑gm IV paracetamol and diclofenac 75mg IV at the end of the surgery. Postoperative analgesia will be provided with Tab PCM 1 gm every 8 hourly and Tab celecoxib 200mg 12 hourly. The patients shall be provided with intravenous patient-controlled analgesia (IVPCA) devices (morphine 1 mg/mL) and will be directed to use them by pushing the button when they feel necessary. The devices will be set to a maximum dose of 24 mg of morphine per day. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.American Society of Anaesthesiologists physical status (ASA) I-III
2.Aged 40 years and above.
3. Patients scheduled for unilateral, primary, total knee replacement under spinal anaesthesia
4.Patients who agree to participate in the study
 
 
ExclusionCriteria 
Details  1.Patient refusal to participate
2.Contraindication to spinal anaesthesia or peripheral nerve blocks (local infection, neurologic deficit or disorder)
3.Patients with significant level of cognitive impairment (inability to communicate pain scores or the need of analgesia)
4.Patients on opioids for chronic pain
5.Revision knee surgery or bilateral TKR
6.History of psychiatric illness
7.Previous trauma or surgery of ipsilateral knee
8.Severe cardiovascular disease and renal disease
9.History of gastrointestinal bleeding or acid peptic disorder
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
The cumulative opioid consumption in the first 24 hours  First 24 hours following surgery 
 
Secondary Outcome  
Outcome  TimePoints 
-Visual analogue score (VAS) at rest and on passive 15° limb lifting at 3, 6,12 and 24 hours postoperatively.
-Time to first rescue analgesic request
-Patient´s satisfaction as per Likerts scale
-Complications like nausea, vomiting, sedation, prolonged
motor blockade
 		 3,6,12 and 24 hours post operatively 
 
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)   15/11/2022 
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    
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

We  will conduct a radomized, double-blind, placebo-controlled trial to hypothesize that genicular nerve blockade (GNB), performed in addition to the standard adductor canal regimen would result in a reduction in 24 hours opioid consumption following total knee replacement surgery. Due to the selective blockade of articular branches and motor sparing effect, GNB can possibly be helpful in early ambulation and faster discharge of the patient following total knee replacement surgery. 

 
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