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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

228 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-05

Study Completion Date

2018-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Osteoarthritis, Hip

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Standard of Care

Group Type ACTIVE_COMPARATOR

Standard of Care

Intervention Type DRUG

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

Multi-modal with as needed opioids

Group Type ACTIVE_COMPARATOR

Multi-modal with as needed opioids

Intervention Type DRUG

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

Multi-modal with one week of opioids offered

Group Type ACTIVE_COMPARATOR

Multi-modal with one week of opioids offered

Intervention Type DRUG

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

Interventions

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Multi-modal with as needed opioids

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

Intervention Type DRUG

Multi-modal with one week of opioids offered

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

Intervention Type DRUG

Standard of Care

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No