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

Not Applicable

Completed

• Conditions: Osteoarthritis, Hip
• Interventions: Drug: Standard of Care; Drug: Multi-modal with as needed opioids; Drug: Multi-modal with one week of opioids offered

• Registration Number: NCT03358888
• Lead Sponsor: Rothman Institute Orthopaedics

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-05
• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-11-27
• Study First Posted: 2017-12-02
• Primary Completion: 2018-01-22
• Study Completion: 2018-02-28
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 228

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care	Standard of Care	-
Multi-modal with as needed opioids	Multi-modal with as needed opioids	-
Multi-modal with one week of opioids offered	Multi-modal with one week of opioids offered	-

Primary Outcome Measures

Name	Time	Method
Pain	30 days post-operative	Pain as reported by Visual Analog Scale
total opioid consumption	total consumption calcuated from surgery date through 30 days post-op

Trial Locations

Locations (1)

Rothman Institute; 🇺🇸 Philadelphia, Pennsylvania, United States