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

NCT01335542 | Completed Phase 4 Results DMC

• 1 other identifier: 2012-056
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Readiness to Discharge

Outcome Measures

Primary Outcomes (1)

• 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 Criteria * Independently transfer from supine to sit, from sitting to standing * Ambulate 40 ft. without assistance * Extension range of motion (\< 10 degrees)

  Participants will be followed for the duration of their hospital stay, an expected average of 3 days

Study Arms (2)

Epidural Pathway (PCEA+FNB)

ACTIVE COMPARATOR

Procedure: Epidural Pathway (PCEA+FNB)

Peri-Articular Injection

ACTIVE COMPARATOR

Procedure: Peri-Articular Injection

Interventions

Peri-Articular Injection PROCEDURE

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)

Peri-Articular Injection

Epidural Pathway (PCEA+FNB) PROCEDURE

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

Epidural Pathway (PCEA+FNB)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Results Point of Contact

• Title: Dr. Jacques YaDeau
• Organization: Hospital for Special Surgery

yadeauj@hss.edu

2127742224

Study Officials

• Jacques T YaDeau, M.D., Ph.D.

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 14, 2011
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: September 1, 2011
• Last Updated: April 14, 2022
• Results First Posted: April 20, 2016

Record last verified: 2022-04

Locations

US (1)