Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03358888
Recruitment Status : Completed
First Posted : December 2, 2017
Last Update Posted : January 29, 2019
Sponsor:
Information provided by (Responsible Party):
Rothman Institute Orthopaedics

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Hip Drug: Multi-modal with as needed opioids Drug: Multi-modal with one week of opioids offered Drug: Standard of Care Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Prolonged Multimodal Analgesia for Post-Discharge Pain Control After Primary Total Hip Arthroplasty
Actual Study Start Date : June 5, 2017
Actual Primary Completion Date : January 22, 2018
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Active Comparator: Standard of Care Drug: Standard of Care
This arm follows standard of care post-operative pain management with oxycodone, tramadol, and acetametophin
Active Comparator: Multi-modal with as needed opioids Drug: Multi-modal with as needed opioids
Multi-modal with as needed oxycodone and tramadol provided for break-through pain
Active Comparator: Multi-modal with one week of opioids offered 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358888


Locations
Layout table for location information
United States, Pennsylvania
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Rothman Institute Orthopaedics
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Rothman Institute Orthopaedics
ClinicalTrials.gov Identifier: NCT03358888    
Other Study ID Numbers: 2017- Chen
First Posted: December 2, 2017    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents