FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/05/008481 [Registered on: 04/05/2017] Trial Registered Prospectively
Last Modified On: 30/05/2017
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Pain relief for single knee replacement surgery 
Scientific Title of Study   A randomized controlled trial to study the effect of ultrasound guided adductor canal block following unilateral total knee arthroplasty: a comparison between ropivacaine versus dexmedetomidine with ropivacaine  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rakhee Goyal 
Designation  Profesor 
Affiliation  Army Hospital (Research and Referral), New Delhi, India 
Address  Army Hospital (Research & Referral), New Delhi, India

South West
DELHI
110010
India 
Phone  7798225637  
Fax  01125684096  
Email  rakheegoyalkumar@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Rakhee Goyal 
Designation  Profesor 
Affiliation  Army Hospital (Research and Referral), New Delhi, India 
Address  Army Hospital (Research & Referral), New Delhi, India

South West
DELHI
110010
India 
Phone  7798225637  
Fax  01125684096  
Email  rakheegoyalkumar@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Rakhee Goyal 
Designation  Profesor 
Affiliation  Army Hospital (Research and Referral), New Delhi, India 
Address  Army Hospital (Research & Referral), New Delhi, India

South West
DELHI
110010
India 
Phone  7798225637  
Fax  01125684096  
Email  rakheegoyalkumar@gmail.com  
 
Source of Monetary or Material Support  
Army Hospital (Research & Referral), New Delhi-110010, India  
 
Primary Sponsor  
Name  Army Hospital Research and Referral Delhi  
Address  Army Hospital Research and Referral Delhi  
Type of Sponsor  Other [An Indian Army hospital and research institution] 
 
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 
Rakhee Goyal  Army Hospital Research and Referral  Department of Anaesthesia and Critical care Army Hospital Research and Referral New Delhi India
South West
DELHI 
7798225637
01125684096
rakheegoyalkumar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Army Hospital Research & Referral, Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Patients scheduled for unilateral total knee arthroplasty,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  20 ml of 0.375% ropivacaine   20 ml of 0.375% ropivacaine will be injected as a single dose into the adductor canal on the operated side by a 21 G 10 cm short bevel needle with a 25 cm long injection line, under ultrasound guidance and aseptic conditions. Total duration of therapy-single dose intervention intended for analgesia for the next 24 hours 
Comparator Agent  20 ml of 0.375% ropivacaine with 0.5μg/kg dexmedetomidine   20 ml of 0.375% ropivacaine with 0.5μg/kg dexmedetomidine will be injected into the adductor canal as a single dose on the operated side by a 21 G 10 cm short bevel needle with a 25 cm long injection line, under ultrasound guidance and aseptic conditions. Total duration-single dose intervention intended for analgesia for the next 24 hours 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  ASA I-III
BMI 20-30 kg/m2
Patients scheduled for elective unilateral total knee arthroplasty 
 
ExclusionCriteria 
Details  Contraindication to subarachnoid block or allergy to any of the study drugs;
Known coagulopathy, local infection at block site;
Patients in whom the nerve block could not be performed at per the procedure described in the methodology;
Renal dysfunction
 
 
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 
Duration of post-operative analgesia   24 hr 
 
Secondary Outcome  
Outcome  TimePoints 
Total 24 hr opioid consumption in the form of intravenous tramadol  24 hr 
Success of early ambulation in terms of steps walked by the patient after surgery  24 hr 
Level of patient satisfaction  At 24 hr 
Any adverse effects , if any  24 hr 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   15/05/2017 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
References 1. Kim DH, Lin Y, Goytizolo EA, Kahn RL, Maalouf DB, Manohar A, Patt ML, Goon AK, Lee YY, Ma Y, Yadeau JT. Adductor canal block versus femoral nerve block for total knee arthroplasty: a prospective, randomized, controlled trial. Anesthesiology 2014;120:540–50 2. Patterson ME, Bland KS, Thomas LC, Elliott CE, Soberon JR Jr, Nossaman BD, Osteen K. The adductor canal block provides effective analgesia similar to a femoral nerve block in patients undergoing total knee arthroplasty—a retrospective study. J Clin Anesth 2015;27:39–44 3. Kwofie MK, Shastri UD, Gadsden JC, Sinha SK, Abrams JH, Xu D, Salviz EA. The effects of ultrasound-guided adductor canal block versus femoral nerve block on quadriceps strength and fall risk: a blinded, randomized trial of volunteers. Reg Anesth Pain Med 2013;38:321–5  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The recent success of adductor canal block in providing post-operative analgesia, along with the prospects of early ambulation has evoked interest in studying the effects of local anesthetics like ropivacaine, and some adjuvants like dexmedetomidine. Both ropivacaine and dexmedetomidine have been effectively and safely used in the past in other peripheral nerve blocks.The aim of this study is to compare the duration of analgesia of adductor canal block using ropivacaine with and without dexmedetomidine after unilateral total knee arthroplasty.

Written informed consent will be taken from all patients meeting the inclusion criteria. They will be randomized into two groups, group A and group B on the basis of a computer generated randomization table. After standard overnight fasting, all the patients will be given a subarachnoid block with 2.5 ml 0.5 % hyperbaric bupivacaine and 25 μg fentanyl for the surgery. Intravenous (iv) dexamethasone 8 mg and 0.02 mg/kg midazolam will be given to all patients. Standard monitoring and iv fluids (balanced salt solution) will be continued during the surgery. After the completion of surgery, the patients will receive ultrasound guided adductor canal block (needle in-plane with the transducer) in the post-operative room using 21 G 10 cm short bevel needle with a 25 cm long injection line. Group A will be given 20 ml of 0.375% ropivacaine with 5 ml saline and Group B will receive 20 ml of 0.375% ropivacaine with 0.25μg/kg dexmedetomidine diluted in a 5 ml volume saline. The drug will be injected below the sartorius and lateral to the femoral artery and the drug spread will be confirmed real time on the ultrasound monitor.

Intravenous paracetamol 15 mg/kg will be given in the ward and repeated orally 8 hourly. One dose of iv diclofenac 50 mg will be given to all patients 2 hr after they reach the ward. Oral pregabalin and etoricoxib will be repeated in the evening.

The ward nurse who is blinded to the study groups will collect the data in the post-operative period. Heart rate, NIBP and SpO2 will be noted every 15 min for the first hour, and every 2 hr till 24 hr. Bradycardia and hypotension will be considered as 20% decrease from baseline and will be treated with iv atropine and mephentermine respectively. Any adverse event such as nausea vomiting, giddiness, signs of local anesthetic toxicity etc. will be noted. Pain will be assessed by the Numeric Rating scale (1-10, 1 being the least and 10 being the worst pain described by the patient). Motor strength will be assessed as per the Medical Research Council Scale as 0-5 at 6, 12, 18 and 24 hr after the block.

Time to first rescue analgesia (in the form of iv tramadol 50 mg) will be noted along with the total tramadol consumption in 24 hr. The physiotherapist will assess the patients on POD1 and assist them to ambulate with support. The time to ambulate will be noted by the nurse. She will also note the patient satisfaction score at 24 hr post operatively; 1-not satisfied, 2-satisfied. The data will be compiled and appropriate statistical tests will be used to analyze it.

 

 
Close