| CTRI Number |
CTRI/2018/05/013680 [Registered on: 04/05/2018] Trial Registered Prospectively |
| Last Modified On: |
16/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
A comparative study between two lower limb nerve blocks in post operative bilateral total knee
replacement patients. |
|
Scientific Title of Study
|
Effect of Adductor canal block versus Femoral nerve block for post operative pain after total knee arthroplasty:A non randomised comparative study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nishith Govil |
| Designation |
Associate professor |
| Affiliation |
All India institute of Medical sciences,rishikesh |
| Address |
Department of anaesthesiology,AIIMS,Rishikesh
Dehradun
Dehradun
UTTARANCHAL
249204
India |
| Phone |
8126101759 |
| Fax |
|
| Email |
nishithgovil@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nishith Govil |
| Designation |
Associate professor |
| Affiliation |
All India institute of Medical sciences,rishikesh |
| Address |
Department of anaesthesiology,AIIMS,Rishikesh
Dehradun
Dehradun
UTTARANCHAL
249204
India |
| Phone |
8126101759 |
| Fax |
|
| Email |
nishithgovil@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nishith Govil |
| Designation |
Associate professor |
| Affiliation |
All India institute of Medical sciences,rishikesh |
| Address |
Department of anaesthesiology,AIIMS,Rishikesh
Dehradun
Dehradun
UTTARANCHAL
249204
India |
| Phone |
8126101759 |
| Fax |
|
| Email |
nishithgovil@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical sciences.(A.I.I.M.S) Virbhadra Road,
Rishikesh -249201,Dehradun (Uttarakhand) |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology,A.I.I.M.S, Rishikesh,Dehradun (Uttarakhand) |
| 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 Vamshi Krishna |
All India Institute of Medical sciences (A.I.I.M.S) |
Department of Anaesthesiology,Virbhadra road,Rishikesh
Dehradun
UTTARANCHAL |
8951511186
1141vamkri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee,AIIMS,Rishikesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ASA I,II AND III, (1) ICD-10 Condition: M170||Bilateral primary osteoarthritis of knee, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Adductor canal block |
Adductor canal block is a relatively new technique where sensory innervation of the knee [saphenous nerve, articular branch from vastus medialis and obturator nerve] is blocked and the block is given distal to most efferent branches to the quadriceps muscle and this helps in preservation of motor strength of this muscle.And the USG guided adductor canal block is given in either of the limb. |
| Comparator Agent |
femoral nerve block |
Femoral nerve block causes motor involvement in addition to the desired sensory blockade, which causes Quadriceps muscle weakness leading to delayed mobilization and increased incidence of fall in the post-operative period.And the USG guided femoral nerve block is give in either of limb. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Age more than 50 years of either sex
2. ASA- I, II and III
3. Patients undergoing primary Bilateral total knee arthroplasty
|
|
| ExclusionCriteria |
| Details |
1] Associated coagulation disorders
2] Severe cardiac, renal or hepatic dysfunction
3] Allergy to TEST drug
4] Any pre-existing sensory or motor impairment
5] Patient refusal/chronic pain medications
6] Patient with cognitive impairment
7] Patient unable to understand study protocol and VAS scoring
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the post-operative analgesia of adductor canal block and femoral nerve block in bilateral total knee arthroplasty with Visual Analog Scale. |
within 48hrs of post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the degree of quadriceps muscle weakness in post total knee arthroplasty in both methods.
2. To assess the degree of knee flexion in post total knee arthroplasty in both methods.
3. To compare complications if any, in either method.
|
With in 48hrs of post operative period
|
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
15/05/2018 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
In this study, we will compare Adductor canal block with femoral nerve block for postoperative analgesia, motor weakness of the quadriceps muscle and degree of knee flexion in patients undergoing primary bilateral total knee arthroplasty[TKA]. Only a few number of studies have compared the ACB approach with FNB approach in a clinical setting involving TKA patients. Since pain perception and pain threshold varies from individual to individual, a significant interpatient variability exists, which can lead to bias. In order to overcome this bias we will be using a method that would allow us to compare both these nerve blocks in the same individual, by enrolling patients undergoing the same surgical procedure in both the lower limbs, such as bilateral TKA. We hypothesised that Adductor canal block [ACB] would provide analgesia non-inferior to femoral nerve block[FNB] as assessed by Visual analogue scale and ACB would be associated with less quadriceps motor weakness than FNB.
|