| 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
|
|
|
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
|
|
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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
|
|
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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
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
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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. |