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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03358888

Enrollment

228

Registered

2017-12-02

Start date

2017-06-05

Completion date

2018-02-28

Last updated

2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Hip

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.

Interventions

DRUGMulti-modal with as needed opioids

Multi-modal with as needed oxycodone and tramadol provided for break-through pain

DRUGMulti-modal with one week of opioids offered

Multi-modal with only one week of oxycodone and tramadol provided for emergency pain relief only

DRUGStandard of Care

This arm follows standard of care post-operative pain management with oxycodone, tramadol, and acetametophin

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026