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CompletedNCT03358888Updated Jan 29, 2019

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

An interventional study of Multi-modal with as needed opioids and Multi-modal with one week of opioids offered in Osteoarthritis, Hip, sponsored by Rothman Institute Orthopaedics. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-29.

Sponsored by Rothman Institute Orthopaedics · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
228
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis, Hip

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
228 participants (actual)

Study arms

  • Active comparator
    Standard of Care

    Drug: Standard of Care

  • Active comparator
    Multi-modal with as needed opioids

    Drug: Multi-modal with as needed opioids

  • Active comparator
    Multi-modal with one week of opioids offered

    Drug: Multi-modal with one week of opioids offered

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

05

What researchers measure

Primary outcomes

  1. total opioid consumption

    Time frame: total consumption calcuated from surgery date through 30 days post-op

  2. Pain

    Pain as reported by Visual Analog Scale

    Time frame: 30 days post-operative

06

Study locations

1 site
  • Rothman Institute
    Philadelphia, Pennsylvania 19107, United States
07

References and documents

Publications

  • Fleischman AN, Tarabichi M, Foltz C, Makar G, Hozack WJ, Austin MS, Chen AF; Opioid Prescription in Orthopedic Surgery after Discharge Research Group. Cluster-Randomized Trial of Opiate-Sparing Analgesia after Discharge from Elective Hip Surgery. J Am Coll Surg. 2019 Oct;229(4):335-345.e5. doi: 10.1016/j.jamcollsurg.2019.05.026. Epub 2019 Jun 5. PubMed 31176028 ↗
08

Registry details

Key details

Study ID
NCT03358888
Lead sponsor
Rothman Institute Orthopaedics
Responsible party
Sponsor
First posted
Dec 2, 2017
Start date
Jun 5, 2017
Primary completion
Jan 22, 2018
Completion
Feb 28, 2018
Last update
Jan 29, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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This study is completed, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.

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