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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03358888
• Other study ID #: 2017- Chen
• Status: Completed
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: January 2019
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 228
• Est. completion date: February 28, 2018
• Est. primary completion date: January 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Drug:
• Multi-modal with as needed opioids
Multi-modal with as needed oxycodone and tramadol provided for break-through pain
• Multi-modal with one week of opioids offered
Multi-modal with only one week of oxycodone and tramadol provided for emergency pain relief only
• Standard of Care
This arm follows standard of care post-operative pain management with oxycodone, tramadol, and acetametophin

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	total opioid consumption		total consumption calcuated from surgery date through 30 days post-op
Primary	Pain	Pain as reported by Visual Analog Scale	30 days post-operative