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Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty

NCT03845881 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2020-07-30

No results posted yet for this study

Summary

To help curb the use of opioid medications following orthopedic surgery investigators have developed a new multi-modal pain pathway. Investigators aim to compare this regimen with and without the inclusion of opioid medications. This study will be performed in a randomized, double-blinded, placebo-controlled fashion in patients undergoing primary total knee or total hip arthroplasty. Investigators hypothesize that the opioid devoid pathway will show equivalent pain scores to the pathway that includes opioids while also having less constipation, nausea, and vomiting following surgery. If successful, this would create a dramatic decrease in opioid consumption following orthopedic surgery while still providing appropriate pain relief to patients.

Conditions

  • Total Knee Arthroplasty

Interventions

DRUG

Oxycodone

The primary endpoint will be pain scores, calculated by the Visual Analog Scale. This score will be collected daily during the hospital examination and by phone surveys for two weeks following discharge. Investigators hypothesize that the non-opioid pain regimen will provide equivalent relief as compared to the opioid regimen.

DRUG

Placebo Oral Tablet

The primary endpoint will be pain scores, calculated by the Visual Analog Scale. This score will be collected daily during the hospital examination and by phone surveys for two weeks following discharge. Investigators hypothesize that the non-opioid pain regimen will provide equivalent relief as compared to the opioid regimen.

Sponsors & Collaborators

  • Ambit Biosciences Corporation

    collaborator INDUSTRY

  • Kern Medical Center

    collaborator OTHER

  • Mayo Clinic

    lead OTHER

Principal Investigators

  • Benjamin Wilke, MD · Mayo Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-10
Primary Completion
2020-07-28
Completion
2020-07-28
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03845881 on ClinicalTrials.gov