Completed

NCT Number: NCT01335542

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

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.

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Key information

Conditions

Readiness to Discharge

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

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

Primary outcomes

The Primary Outcome is Time Until a Patient is "Ready for Discharge."

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Acronym: PAI vs FNB

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Apr 14, 2011
Registry last updated: Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.