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Completed

NCT Number: NCT03358888

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

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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Key information

Conditions

Osteoarthritis, Hip Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-modal with as needed opioids

Drug

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

Multi-modal with one week of opioids offered

Drug

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

Standard of care

Drug

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

Primary outcomes

  1. total opioid consumption

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

  2. Pain

    Time frame: 30 days post-operative

    Pain as reported by Visual Analog Scale

Sponsors and collaborators

Lead sponsor

Rothman Institute Orthopaedics

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2017
Registry last updated
Jan 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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