Ignite Creation Date:
2024-05-06 @ 7:50 AM
Last Modification Date:
2024-10-26 @ 11:52 AM
Study NCT ID:
NCT02603900
Status:
WITHDRAWN
Last Update Posted:
2021-12-15
First Post:
2015-10-22
Brief Title:
Adductor Canal Catheter vs Local Infiltration of Analgesia for Total Knee Arthroplasty
Sponsor:
Thomas Jefferson University
Organization:
Thomas Jefferson University
Study Overview
Official Title:
A Double-Blinded Randomized Controlled Trial Comparing the Adductor Canal Catheter ACC and Local Infiltration of Analgesia LIA Following Primary Total Knee Arthroplasty
Status:
WITHDRAWN
Status Verified Date:
2021-12
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:
None
Brief Summary:
The study is a prospective randomized controlled trial comparing local infiltration of analgesia in the knee joint and adductor canal catheters for postoperative analgesia following a primary Total Knee Arthroplasty TKA
Detailed Description:
The study is a prospective randomized controlled clinical trial comparing two methods of postoperative analgesia following primary TKA Eligible primary TKA patients must be ASA I - III and require less than 20 mg oxycodone daily or its equivalent Exclusion criteria are allergy to anesthetics contraindication to regional anesthesia sensory motor disorder involving operative limb non-english speaking ASA IV or greater psychiatric or cognitive disorders incarceration renal insufficiency with Cr 20 and hepatic failure When patients agree to participate in the study the following data will be collected by the research staff ASA physical status age height weight gender quantitative opiate use numeric pain score with visual descriptors painDETECT score WOMAC score and baseline Pain Management Questionnaire When designated through randomization local infiltration of analgesia will be placed intraoperatively by the surgeons per usual protocol and patients in the LIA group will receive sham adductor canal catheter All ACCs for both study groups will be placed postoperatively in the PACU Those collecting data will be blinded from identifying patients in the control group as both groups will have ACC placed with same technique Potential risks for each procedure which will be explained to the patient include bleeding local infection local anesthetic toxicity in the form of seizure and cardiac arrest and neuropathy The preceding are commonly listed though infrequent complications of both procedures Continuous ultrasound will guide the placement of the ACC All adductor canal catheters will remain in for 72 hours Pt from LIA group will be discharged home with sham catheter with a saline infusion at 10 mlhr via an ambulatory pump Patients in ACC group will be discharged with continuous adductor canal catheter delivering ropivacaine 02 at 10 mlhr via an ambulatory pump Patients will be called daily for pain diary results As well as at 6-8 weeks postoperatively to collect painDetect and WOMAC survey
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