| CTRI Number |
CTRI/2019/03/018239 [Registered on: 25/03/2019] Trial Registered Prospectively |
| Last Modified On: |
20/03/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of multiple pain management regimes in total knee joint replacement a randomized control trial study |
|
Scientific Title of Study
|
Comparison of single shot adductor canal block versus continuous adductor canal block for pain management in total knee arthroplasty a randomized 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 |
Rajat Tak |
| Designation |
Fellow arthroplasty |
| Affiliation |
sunshine hospitals |
| Address |
Room no 1 ortho OPD , sunshine hospitals PG road opposite parsi dharamshala
secunderabad
sunshine hospitals PG road opposite parsi dharamshala
secunderabad
telangana
Hyderabad
TELANGANA
500003
India |
| Phone |
9450173324 |
| Fax |
|
| Email |
drrajattak06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
kishore |
| Designation |
Registrar arthroplasty |
| Affiliation |
sunshine hospitals |
| Address |
Room no 1 ortho OPD , sunshine hospitals PG road opposite parsi dharamshala
secunderabad
sunshine hospitals PG road opposite parsi dharamshala
secunderabad
telangana
Hyderabad
TELANGANA
500003
India |
| Phone |
7506255474 |
| Fax |
|
| Email |
laxman.kishor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rajat Tak |
| Designation |
Fellow arthroplasty |
| Affiliation |
sunshine hospitals |
| Address |
Room no 1 ortho OPD , sunshine hospitals PG road opposite parsi dharamshala
secunderabad
sunshine hospitals PG road opposite parsi dharamshala
secunderabad
telangana
Hyderabad
TELANGANA
500003
India |
| Phone |
9450173324 |
| Fax |
|
| Email |
drrajattak06@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
sunshine hospital |
| Address |
sunshine hospital PG road opposite to parsi dharamshala secunderabad - 500003
telangana |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| rajat tak |
sunshine hospital |
room no 1 ortho opd
sunshine hospital PG road
opposite parsi dharmshala
secunderabad - 500003
Hyderabad
TELANGANA |
9450173324
drrajattak06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee sunshine hospitals |
Approved |
|
|
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 |
adductor canal block anaesthesia in total knee replacement. |
group 1 single injection adductor canal block ,
group 2 single injection adductor canal block and inj in interspace between popliteal artery and posterior capsule,
group 3 continuous adductor canal block via catheter |
| Comparator Agent |
not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients scheduled to undergo unilateral TKA under spinal anaesthesia . |
|
| ExclusionCriteria |
| Details |
Bilateral
Epidural / GA
Creatinine > 1.2 , renal or hepatic dysfunction.
Allergic to any study medication , chronic opiod use , BMI >40
Chronic pain unrelated to knee joint
|
|
|
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 |
1.Pain Score : VAS (Visual Analog Score)
2. Knee ROM.
3. Ambulation distance
4 .Opiate Consumption at 12 ,24,48 hrs.( calculation in morphine equivalents)
5. Anti Emetics usage
6. Timing of breakthrough medication (IV paracetamol)
7. Length of stay
8. Discharge day
9. Patient satisfaction.
10. Active Quadriceps holding time
|
1.Pain Score : VAS (Visual Analog Score)
2. Knee ROM.
3. Ambulation distance
4 .Opiate Consumption at 12 ,24,48 hrs.( calculation in morphine equivalents)
5. Anti Emetics usage
6. Timing of breakthrough medication (IV paracetamol)
7. Length of stay
8. Discharge day
9. Patient satisfaction.
10. Active Quadriceps holding time
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="60"
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)
|
01/04/2019 |
| 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="1"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1. A Randomized Non-Inferiority Trial of Adductor Canal Block for Analgesia After Total Knee Arthroplasty: Single Injection Versus Catheter Technique.
Lee S1, Rooban N1, Vaghadia H1, Sawka AN1, Tang R1.
J Arthroplasty. 2018 Apr;33(4):1045-1051. doi: 10.1016/j.arth.2017.11.018. Epub 2017 Nov 16.
2. Adductor Canal Blockade Following Total Knee Arthroplasty—Continuous or Single Shot Technique? Role in Postoperative Analgesia, Ambulation Ability and Early Functional Recovery: A Randomized Controlled Trial
Nilen A. Shah, MS, MCH(orth)a,low asteriskCorrespondence information about the author MS, MCH(orth) Nilen A. Shah, Nimesh P. Jain, MS(orth.)a,b, Karnav A. Panchal, MS(orth.)
DOI: https://doi.org/10.1016/j.arth.2015.03.006 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
AIM : To study and compare
the effectiveness of Multimodal Perioperative analgesia regime in pain management and early
rehabilitation following total knee arthroplasty.
1.Single injection Adductor Canal Block +
Infiltration of LA- iPAC (interspace b/w popliteal artery and capsule of posterior knee)
2.Single injection Adductor Canal Block
3.Continuous Adductor Canal Block With
Catheter.
HYPOTHESIS Superiority
of catheter technique or iPAC + single inj.
ACB over single injection adductor canal block in terms of
postoperative analgesia , mobilization , early functional recovery and time to
discharge ACB:
20 ml of 0.2% Ropivacaine iPAC : 20 ml of 0.2 % Ropivacaine CACB : 20 ml 0.2 % Ropivacaine through catheter infusion @ 6 ml / hr .
|