| CTRI Number |
CTRI/2020/07/026704 [Registered on: 20/07/2020] Trial Registered Prospectively |
| Last Modified On: |
20/07/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Regional anaesthetic technique] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Pain relief in total knee replacement |
|
Scientific Title of Study
|
Analgesic efficacy of adductor canal block (single shot + continuous infusion) versus epidural infusion in patients undergoing unilateral total knee arthroplasty |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tasnim Hozefa Karachiwala |
| Designation |
Senior Registrar |
| Affiliation |
Ruby Hall Clinic |
| Address |
Ruby Hall Clinic,
40, Sassoon Road,
Pune
28/ 2 safe society B.T Kawade road, Pune
Pune
MAHARASHTRA
411001
India |
| Phone |
9860893851 |
| Fax |
|
| Email |
drtasnim.u@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tasnim Hozefa Karachiwala |
| Designation |
Senior Registrar |
| Affiliation |
Ruby Hall Clinic |
| Address |
Ruby Hall Clinic,
40, Sassoon Road,
Pune – 411001,
Maharashtra, India
28/ 2 safe co operative housing society
B. T Kawade road, Pune 13
Pune
MAHARASHTRA
411001
India |
| Phone |
9860893851 |
| Fax |
|
| Email |
drtasnim.u@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tasnim Hozefa Karachiwala |
| Designation |
Senior Registrar |
| Affiliation |
Ruby Hall Clinic |
| Address |
Ruby Hall Clinic,
40, Sassoon Road,
Pune – 411001,
Maharashtra, India
28/ 2 safe co operative housing society,B.T. Kawade road, Pune- 13
Pune
MAHARASHTRA
411001
India |
| Phone |
9860893851 |
| Fax |
|
| Email |
drtasnim.u@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ruby Hall Clinic |
| Address |
Ruby Hall Clinic,
40, Sassoon Road,
Pune – 411001,
Maharashtra, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| NITA DSOUZA |
Ruby Hall Clinic, Pune |
Ruby Hall Clinic,
40, Sassoon Road,
Pune – 411001,
Maharashtra, India
Pune
MAHARASHTRA |
9823721982
drnita610@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Poona medical research foundation |
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 |
Epidural versus adductor canal catheter |
In 21 patients pain relief will be via epidural infusion continuous for 48 hours and in other 21 via adductor canal catheter single shot 10 ml + infusion of 8ml/hr for 48 hours
Concentration of drug used for epidural is 0.1% ropivacaine +2mcg/ml fentanyl infusion at 4-6 ml/hr
Adductor canal drug used will be 0.1% ropivacaine at 8ml/hr infusion for 48 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Belonging to ASA 1 and 2 undergoing unilateral arthropathy |
|
| ExclusionCriteria |
| Details |
a) Patients refusiong to give their consent for the study
b) Patients refusing Regional Anaesthesia/ or to have any continuous catheters in their body
c) Patients having absolute or relative contra- indications to Regional Anaesthesia
d) Patients having a revision TKR
e) History of neurological abnormality in the operating leg eg. History of chronic pain, stroke or previous nerve injury
f) Allergy or any contra- indication to drugs used in this study
g) Morbidly obese ( BMI > 40 )
h) History of alcohol or drug abuse
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| assess analgesic efficacy by noting the VAS score at rest and on movement postoperatively |
0 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Ability to do straight leg raising test suggestive of motor or sensory block as a consequence of ACB or EA 2) Time to first successful ambulation 3) Time to first self micturition in ACB group
(as EA group patients catheterized) 4) Analgesics used over 48 hours as a part of multimodal analgesic regimen in both groups 5) adverse events observed in either group 6) Length of hospital stay and 7) Chronic pain at 6 months follow up
|
0 hrs, 4 hrs, 8 hrs, 12 hrs, 24 hrs, 48 hrs |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 1 |
|
Date of First Enrollment (India)
|
20/07/2020 |
| 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="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Patients undergoing total knee arthroplasty experience a lot of pain. A good analgesia in turn leads to quicker mobilization and lesser length of hospital stay which in turn is cost effective. In this study, a comparison was made between epidural infusion and adductor canal infusion keeping LIA and systemic analgesics common in both the groups. Another important aspect of this study is the evaluation of pain at 3 months post surgery as the incidence of chronic pain has been seen in approximately 20% of patients postoperatively. |