| CTRI Number |
CTRI/2020/10/028528 [Registered on: 21/10/2020] Trial Registered Prospectively |
| Last Modified On: |
30/09/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Adductor canal block with different additives for total knee replacement surgery |
|
Scientific Title of Study
|
Comparison of Analgesic Effect of Dexmedetomidine and Fentanyl with Ropivacaine in Adductor Canal Block in Patients Undergoing Unilateral Total Knee Replacement Surgery: A Triple Blinded Randomised Control Trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Snigdha Naskar |
| Designation |
Junior resident |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Anaesthesiology Level 6 Medical College building AIIMS Rishikesh
Department of Anaesthesiology Level 6 Medical College building AIIMS Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
8420899672 |
| Fax |
|
| Email |
naskarsnigdha05@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Yashwant Singh Payal |
| Designation |
Additional professor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Anaesthesiology Level 6 Medical College Building, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7906235754 |
| Fax |
|
| Email |
dryspayal05@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Yashwant Singh Payal |
| Designation |
Additional professor |
| Affiliation |
AIIMS RISHIKESH |
| Address |
Department of Anaesthesiology Level 6 Medical College Building, All India Institute of Medical Sciences, Rishikesh
Dehradun
UTTARANCHAL
249203
India |
| Phone |
7906235754 |
| Fax |
|
| Email |
dryspayal05@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS RISHIKESH |
| Address |
VEERBHADRA ROAD ,249201 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Yashwant Singh Payal |
AIIMS RISHIKESH |
Department of Anaesthesiology 6th floor Virbhadra Marg Pashulok Rishikesh
Dehradun
UTTARANCHAL |
7906235754
dryspayal05@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M171||Unilateral primary osteoarthritisof knee, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Group A: Post operative adductor canal block with ropivacaine and dexmedetomidine |
Block will be given with 15 ml of 0.5% ropivacaine + dexmedetomidine 1 microgram per kg under USG guidance (20 ml of drug) |
| Intervention |
Group B: Post operative adductor canal block with ropivacaine and fentanyl |
Block will be given with 15ml of 0.5% ropivacaine + fentanyl 1microgram per kg under USG guidance (20 ml drug) |
| Comparator Agent |
Post- operative adductor canal block in patients undergoing unilateral total knee replacement |
A curvilinear low frequency ultrasound probe placed at mid- thigh and identified femoral artery, femoral vein and saphenous nerve deep to Sartorius muscle in between vastus medialis and adductor longus. A 18G touhy needle with 22G catheter attached inserted in between the muscle and local anaesthetic injected after negative aspiration according to the groups |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
ASA –I, II
Patients undergoing primary unilateral total knee replacement
|
|
| ExclusionCriteria |
| Details |
1.BMI > 35 kg/m2
2.Associated coagulation disorders
3.Infection at the site of injection
4.Severe cardiac,renal or hepatic dysfunction
5.Allergy to test drug
6.Any pre– existing sensory or motor impairement
7.Patient with cognitive impairement
8.Patient refusal to participate
9.Emergency surgery
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare duration of analgesia (request for first rescue analgesia) after single-shot adductor canal block with ropivacaine and adjuvants (dexmedetomedine, fentanyl) in patients at rest undergoing primary unilateral total knee replacement with Numeric rating scale |
At the first request for rescue analgesia in the post operative period during first 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To assess pain scores by numerical rating scale (NRS) post operatively
2.To compare total rescue analgesia requirement in first 24hour after block
3.To compare level of sensory block with either of adjuvants after ACB
4.To compare any degree of motor blockade with any adjuvants in adductor canal block by modified bromage scale.
5.To compare complications, if any ,while using either of the drugs
|
Patient assessment for pain at 1,6,12,18 and 24 hour after block
|
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
01/11/2020 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Kampitak W, Tanavalee A, Ngarmukos S, Amarase C, Songthamwat B, Boonshua A. Comparison of Adductor Canal Block Versus Local Infiltration Analgesia on Postoperative Pain and Functional Outcome after Total Knee Arthroplasty: A Randomized Controlled Trial. Malays Orthop J. 2018 Mar;12(1):7–14.
2. Comparison of Adductor Canal Block Versus Local Infiltration Analgesia on Postoperative Pain and Functional Outcome after Total Knee Arthroplasty: A Randomized Controlled Trial. Malays Orthop J. 2018;12(1):8.
3. Schnabel A, Reichl SU, Weibel S, Zahn PK, Kranke P, Pogatzki-Zahn E, et al. Adductor canal blocks for postoperative pain treatment in adults undergoing knee surgery. Cochrane Database Syst Rev. 2019 Oct 26;2019(10).
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
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Brief Summary
|
Adductor canal block is a ultrasound guided regional anaesthesia technique, involves infiltration of local anaesthesia to the saphenous nerve,nerve to vastus medialis. Hypothesis: Adding two different analgesic drugs along with ropivacaine will show the efficacy of adjuvants in terms of prolong of duration and quality of analgesia in post- operative period Aim: To study and compare dexmedetomidine and fentanyl with ropivacaine as analgesics post operatively given through single- shot block in Primary unilateral total knee replacement Objectives: To compare duration of analgesia (request for first rescue analgesia) after single-shot adductor canal block with Numeric rating scale Material &methods: A triple blinded randomised control trial Sample size: 35 patients in each group |