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

Primary Purpose

Osteoarthritis, Hip

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Multi-modal with as needed opioids

Multi-modal with one week of opioids offered

Standard of Care

About this trial

This is an interventional prevention trial for Osteoarthritis, Hip

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Rothman Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

Standard of Care

Multi-modal with as needed opioids

Multi-modal with one week of opioids offered

Arm Description

Outcomes

Primary Outcome Measures

total opioid consumption

Pain

Pain as reported by Visual Analog Scale

Secondary Outcome Measures

Full Information

NCT ID

NCT03358888

First Posted

November 27, 2017

Last Updated

January 25, 2019

Sponsor

Rothman Institute Orthopaedics

1. Study Identification

Unique Protocol Identification Number

NCT03358888

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2019

Overall Recruitment Status

Completed

Study Start Date

June 5, 2017 (Actual)

Primary Completion Date

January 22, 2018 (Actual)

Study Completion Date

February 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rothman Institute Orthopaedics

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Hip

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

228 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard of Care

Arm Type

Active Comparator

Arm Title

Multi-modal with as needed opioids

Arm Type

Active Comparator

Arm Title

Multi-modal with one week of opioids offered

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Multi-modal with as needed opioids

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Multi-modal with one week of opioids offered

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Standard of Care

Intervention Description

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

Primary Outcome Measure Information:

Title

total opioid consumption

Time Frame

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

Title

Pain

Description

Pain as reported by Visual Analog Scale

Time Frame

30 days post-operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

Rothman Institute

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

31176028

Citation

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.

Results Reference

derived

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

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