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CTRI Number  CTRI/2023/11/059394 [Registered on: 01/11/2023] Trial Registered Prospectively
Last Modified On: 25/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Comparison of postoperative pain relief by two types of nerve blocks after arthroscopic knee surgery. 
Scientific Title of Study   Comparison of postoperative pain relief with single shot adductor canal block with or without infiltration between popliteal artery and capsule of knee block for patients undergoing knee arthroscopy. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrDivya Shree R 
Designation  Junior resident 
Affiliation  Government medical college and hospital  
Address  Department of Anaesthesia and intensive care Government medical college and hospital sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9008417024  
Fax    
Email  divyamdgmch@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DrSukanya Mitra 
Designation  Associate Professor  
Affiliation  Government medical college and hospital  
Address  Department of anaesthesia and intensive care Government medical college and hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121521  
Fax    
Email  drsmitra12@yahoo.com  
 
Details of Contact Person
Public Query  
Name  DrSukanya Mitra 
Designation  Associate Professor  
Affiliation  Government medical college and hospital  
Address  Department of anaesthesia and intensive care Government medical college and hospital Sector 32 Chandigarh

Chandigarh
CHANDIGARH
160030
India 
Phone  9646121521  
Fax    
Email  drsmitra12@yahoo.com  
 
Source of Monetary or Material Support  
Government medical college and hospital sector 32 Chandigarh  
 
Primary Sponsor  
Name  Government medical college and hospital  
Address  Department of anaesthesia and intensive care Government medical college and hospital Sector 32 Chandigarh  
Type of Sponsor  Government 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 
DrSUKANYA MITRA   Government medical college and hospital   Department of anaesthesia and intensive care D block 5th floor
Chandigarh
CHANDIGARH 		 9646121521

Drsmitra12@yahooo.com 
 
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: S833||Tear of articular cartilage of knee, current,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adductor canal block with IPACK block  Ultrasound guided ACB with patient in supine position with 100mm sonoplex needle at mid thigh level and 20 ml 0.5% ropivacaine plus 4 mg dexamethasone will be injected perineurally . The IPACK block performed with infiltration of 20ml of 0.2% ropivacaine via 22 gauge ,100 mm length ( Braun stimuplex ) between the popliteal artery and capsule of knee (IPACK) with knee slightly flexed in pre operative period 
Comparator Agent  Adductor canal block with IPACK block ( sham block )   Ultrasound guidedACB with patient in supine position with 100 mm sonoplex needle at mid thigh and 20 ml 0.5% ropivacaine plus 4 mg dexamethasone will be injected perineurally. The IPACK block preformed with infiltration with normal saline via 22 Gauge 100 mm length ( Braun stimuplex) between the popliteal artery and capsule of knee (IPACK ) with knee slightly flexed in pre operative period 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1 Age between 18 to 65 years
2 American society of anaesthesiologists (ASA) physical status 1 and 2
3.BMI 18 to 30 kg/m2
4 patients scheduled for knee arthroscopy  
 
ExclusionCriteria 
Details  1 patients refusing to give informed consent
2 patients with history of relevant drug allergy
3 patients with history of psychiatric illness and substance abuse
4 patients with severe cardiovascular respiratory metabolic or neurological disorders
5 pregnant and lactating women
6 patients with coagulopathy and bleeding disorders
7 infection at planned injection site
8 patient on steroids  
 
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 
rescue fentanyl consumption   4 hour, 12 hour, 24 hour 
 
Secondary Outcome  
Outcome  TimePoints 
Time to first rescue analgesia
 		 Immediately after the block then 5 10 15 60 minutes followed by 4 12 24 hour interval  
Pain scores on NRS   4 12 and 24 hours after administration of block  
Patient satisfaction on 0- 100 VAS   4 12 24 hours after administration of block 
Sensory and motor blockade   4 12 24 hours after administration of block 
Side effects   4 12 24 hours after administration of block  
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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   Phase 3/ Phase 4 
Date of First Enrollment (India)   06/11/2023 
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="1"
Months="6"
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   Pain due to knee arthroscopic surgeries leads to diff in early ambulation and increased opioid use. Therefore, regional anaesthesia techniques are being increasing used to treat postoperative pain . Adductor canal block has the disadvantage of being unable to alleviate posterior knee pain . The study is designed to compare the effect of ultrasound guided adductor canal block plus IPACK versus ultrasound guided adductor canal block alone for postoperative analgesia in patients undergoing knee arthroscopic surgeries. 
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