Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade (PAI vs FNB)

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.

Study Overview

• Status: Completed
• Conditions: Readiness to Discharge
• Intervention / Treatment: Procedure: Epidural Pathway (PCEA+FNB); Procedure: Peri-Articular Injection

• Study Type: Interventional
• Enrollment (Actual): 91
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Epidural Pathway (PCEA+FNB)	Procedure: Epidural Pathway (PCEA+FNB); Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
Active Comparator: Peri-Articular Injection	Procedure: Peri-Articular Injection; Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Primary Outcome is Time Until a Patient is "Ready for Discharge."	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 CriteriaIndependently transfer from supine to sit, from sitting to standingAmbulate 40 ft. without assistanceExtension range of motion (< 10 degrees)	Participants will be followed for the duration of their hospital stay, an expected average of 3 days

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: March 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 8, 2011
• First Submitted That Met QC Criteria: April 13, 2011
• First Posted (Estimate): April 14, 2011

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 12, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2012-056