Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade

Phase 4

Completed

• Conditions: Readiness to Discharge
• Interventions: Procedure: Epidural Pathway (PCEA+FNB); Procedure: Peri-Articular Injection

• Registration Number: NCT01335542
• Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary

There are 2 common ways to manage pain after total knee arthroplasty at our institution. Some patients receive an epidural analgesia, a femoral nerve block and pills for pain. More recently, some surgeons have replaced femoral nerve blockade with peri-articular injections. These patients receive a peri-articular injection (injection of pain medication around the knee), pills for pain and a pain patch on the skin. The purpose of this research project is to find out if one of these ways to treat pain is better than the other. The investigators will look at this question in many ways, but the main way is how long it takes for you to be judged ready for discharge from the hospital.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Primary Completion: 2011-03
• Study First Submitted: 2011-04-08
• Study First Submitted QC: 2011-04-13
• Study First Posted: 2011-04-14
• Study Completion: 2011-09
• Results First Submitted: 2016-03-21
• Results First Submitted QC: 2016-03-21
• Results First Posted: 2016-04-20
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-12
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Patients with osteoarthritis scheduled for primary bicompartmental total knee arthroplasty with a participating surgeon
• Age 18 to 85 years old
• Planned use of regional anesthesia
• Ability to follow study protocol
• Up to 15 degrees varus, up to 15 degrees flexion and up to 15 degrees valgus

Exclusion Criteria

• Patients younger than 18 years old and older than 85
• Patients intending to receive general anesthesia
• Allergy or intolerance to one of the study medications
• Patients with an ASA of IV
• Patients with insulin-dependent diabetes
• Patients with hepatic (liver) failure
• Patients with chronic renal (kidney) failure
• Chronic opioid use (taking opioids for longer than 3 months)
• Patients with any prior major ipsilateral open knee surgery.
• Patients with flexion contracture of knee > 15 degrees
• Patients with varus deformity > 15 degrees
• Patients with valgus deformity > 15 degrees
• Patients with a contraindication to use of epinephrine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidural Pathway (PCEA+FNB)	Epidural Pathway (PCEA+FNB)	-
Peri-Articular Injection	Peri-Articular Injection	-

Primary Outcome Measures

Name	Time	Method
The Primary Outcome is Time Until a Patient is "Ready for Discharge."	Participants will be followed for the duration of their hospital stay, an expected average of 3 days	The primary outcome is time until a patient is "ready for discharge." Discharge criteria are: * PCA (if present) has been discontinued; * Not experiencing moderate or severe nausea (within last 4 hours).; * Solid food diet; * Able to urinate (Foley catheter removed); * Pain: NRS \<4.; * Surgical wound dry; * No acute medical problems; * Physical Therapy Criteria; * Independently transfer from supine to sit, from sitting to standing; * Ambulate 40 ft. without assistance; * Extension range of motion (\< 10 degrees)

Trial Locations

Locations (1)

Hospital for Special Surgery; 🇺🇸 New York, New York, United States