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

NCT03845881 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 18-004256
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain Levels

  compare the postoperative pain levels both in the hospital setting as well as daily for two weeks following discharge between patients in the opioid treatment group and those in the non-opioid treatment group. This will be performed with clinical exams while in the hospital and with phone surveys on discharge. Results will be recorded using the Visual Analog Scale for pain scores. This scale ranges from 0 to 10, with zero being no pain and 10 being as bad as can be, and includes visual facial cues. Following this scale, investigators will also ask about sleep, activity, mood, and stress.

  2 weeks

Secondary Outcomes (3)

• Opioid Levels

  2 weeks

• Side effects

  2 weeks

• Length of hospitalization

  2 weeks

Study Arms (2)

Opioid

ACTIVE COMPARATOR

Multi-Modal Pain Protocol with Opioids Following Total Joint Arthroplasty

Drug: Oxycodone

Non Opioid

PLACEBO COMPARATOR

Multi-Modal Pain Protocol without Opioids Following Total Joint Arthroplasty

Drug: Placebo Oral Tablet

Interventions

Oxycodone DRUG

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.

Opioid

Placebo Oral Tablet DRUG

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.

Non Opioid

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 and \< 90 years.
• Willing to participate in the study and competent to provide informed consent.
• Willing to comply with protocol procedures.
• Has an underlying diagnosis of osteoarthritis indicated for knee arthroplasty.

You may not qualify if:

• A diagnosis of renal or liver disease
• If a patient has a contraindication to receiving a spinal anesthetic or pain catheter
• The patient must not have taken any narcotic medications during the 3 months leading up to the surgery
• The patient must not be allergic or intolerant to a medication used in the multi-modal pain pathway
• Revision hip or knee arthroplasty
• If a patient is being treated under worker's compensation
• If a patient has diabetes
• Unable to take Aspirin 325 mg twice daily for deep venous thromboprophylaxis

Sponsors & Collaborators

• Mayo Clinic: lead
• Ambit Biosciences Corporation: collaborator
• Kern Medical Center: collaborator

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Interventions

Oxycodone

Intervention Hierarchy (Ancestors)

Codeine; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Benjamin Wilke, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The oxycodone and placebo tablets will be encapsulated by the research pharmacy prior to dispensing for blinding purposes.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Multi-Modal Pain Protocol with and without Opioids Following Total Joint Arthroplasty

Study Record Dates

• First Submitted: February 11, 2019
• First Posted: February 19, 2019
• Study Start: April 10, 2019
• Primary Completion: July 28, 2020
• Study Completion: July 28, 2020
• Last Updated: July 30, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)