NCT03358888

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
228

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 2, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 22, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

January 29, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

November 27, 2017

Last Update Submit

January 25, 2019

Conditions

Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (2)

  • total opioid consumption

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

  • Pain

    Pain as reported by Visual Analog Scale

    30 days post-operative

Study Arms (3)

Standard of Care

ACTIVE COMPARATOR
Drug: Standard of Care

Multi-modal with as needed opioids

ACTIVE COMPARATOR
Drug: Multi-modal with as needed opioids

Multi-modal with one week of opioids offered

ACTIVE COMPARATOR
Drug: Multi-modal with one week of opioids offered

Interventions

Multi-modal with as needed opioidsDRUG

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

Multi-modal with as needed opioids
Multi-modal with one week of opioids offeredDRUG

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

Multi-modal with one week of opioids offered
Standard of CareDRUG

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

Standard of Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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.

    PMID: 31176028DERIVED

MeSH Terms

Conditions

Osteoarthritis, Hip

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2017

First Posted

December 2, 2017

Study Start

June 5, 2017

Primary Completion

January 22, 2018

Study Completion

February 28, 2018

Last Updated

January 29, 2019

Record last verified: 2019-01

Locations

US(1)