Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty

Rothman Institute Orthopaedics

Status: Completed

Conditions: Osteoarthritis, Hip

Treatments: Drug: Multi-modal with one week of opioids offered; Drug: Standard of Care; Drug: Multi-modal with as needed opioids

Study type: Interventional

Funder types: Other

Identifiers

NCT03358888

2017- Chen

Details and patient eligibility

About

This is a prospective, three-arm, comparative study with a provider-crossover design. The first arm will comprise the standard of care pain regimen after discharge, which comprises PRN oxycodone, tramadol, and acetaminophen. The second arm will comprise a multimodal pain regimen; however, patients will still be routinely provided PRN oxycodone and tramadol to use on an as needed basis. The third arm will comprise a multimodal pain management protocol, which does not routinely allow for opioid consumption. However, patients will be provided a one week supply of oxycodone and tramadol for emergency pain relief only.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing unilateral, primary cementless THA with underlying diagnosis of osteoarthritis.
• ASA I - III
• Spinal anesthesia
• Male and Female over 18 who are willing and able to provide informed consent

Exclusion criteria

• Opioid use within 3 months prior to surgery
• General anesthesia
• Non-english speaking
• ASA IV or greater
• Allergy/contraindications to protocol medications
• Renal insufficiency with Cr > 2.0 or hepatic failure
• Sensory/motor disorder involving the operative limb
• Planned or unplanned discharge to rehab
• Length of stay >3 days
• Revision or conversion THA
• Cigarette smokers

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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228 participants in 3 patient groups

Standard of Care

Active Comparator group

Treatment:

Drug: Standard of Care

Multi-modal with as needed opioids

Active Comparator group

Treatment:

Drug: Multi-modal with as needed opioids

Multi-modal with one week of opioids offered

Active Comparator group

Treatment:

Drug: Multi-modal with one week of opioids offered