Ignite Creation Date:
2024-05-06 @ 12:36 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01616836
Status:
COMPLETED
Last Update Posted:
2016-04-13
First Post:
2012-06-07
Brief Title:
Optimizing Pain and Rehabilitation After Knee Arthroplasty
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Sunnybrook Health Sciences Centre
Study Overview
Official Title:
Optimizing Pain and Rehabilitation After Knee Arthroplasty - Randomized Blinded Clinical Trial Comparing Continuous Femoral Nerve Block Versus Single Injection Femoral Nerve Block Versus Local Infiltration Analgesia
Status:
COMPLETED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OPRA
Brief Summary:
The aim of this study is to determine the best method of pain control that will help with rehabilitation after total knee arthroplasty TKA Currently the best method for pain control after TKA appears to be continuous femoral nerve block FNB where a small tube is placed beside the nerve that provides sensation to a large part of the knee and local anesthetic infused after surgery causing numbness to the surgical site A single injection method also exists and may provide similar benefits Both methods require training and can result in side effects such as temporary weakness while the local anesthetic is still working that can inhibit rehabilitation A newer method injecting local anesthetic into the joint after surgery Local Infiltration Analgesia LIA is becoming common does not cause weakness and can be done quickly at the end of surgery It is unknown if the pain control provided by LIA is as good as that of FNB This study will compare the femoral nerve block continuous femoral nerve block and LIA technique to determine which provides better pain relief after TKA
Detailed Description:
This will be a prospective randomized double blind study Patients will be randomized using a computer-generated sequence to one of three groups
Group 1 Continuous femoral nerve block group cFNB Group 2 Single injection femoral nerve block group sFNB Group 3 Local infiltration analgesia group LIA
Inclusion criteria Patients between the ages of 18 and 85 having primary tri-compartmental total knee arthroplasty
Exclusion criteria Allergy intolerance or contraindication to any study medication see below inability to walk independently prior to TKA inability to comprehend French or English use of major tranquilizers ASA 4 or 5 BMI 40 opioid tolerance opioid consumption 30mg oral morphine or equivalent per day pregnancy
Group 1 Continuous femoral nerve block group cFNB Group 2 Single injection femoral nerve block group sFNB Group 3 Local infiltration analgesia group LIA
Inclusion criteria Patients between the ages of 18 and 85 having primary tri-compartmental total knee arthroplasty
Exclusion criteria Allergy intolerance or contraindication to any study medication see below inability to walk independently prior to TKA inability to comprehend French or English use of major tranquilizers ASA 4 or 5 BMI 40 opioid tolerance opioid consumption 30mg oral morphine or equivalent per day pregnancy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None