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Completed

NCT Number: NCT03845881

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

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.

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Key information

Conditions

Total Knee Arthroplasty

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

About this study

  • Aim 1 will be to 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.
  • Aim 2 will be to compare the overall morphine equivalents used during hospitalization between the opioid and non-opioid treatment groups. This will be calculated based on the amount of intravenous breakthrough narcotic pain medication used in the hospital setting (divided by the total number of post-surgery hospitalization hours to account for varying lengths of stay). Investigators will also measure the total number of opioid pills (these would be placebo pills for the non-opioid group) consumed during the first two weeks post-discharge, and the post-surgery day on which opioid pills were discontinued, and compare these outcomes between the opioid and non-opioid groups.
  • Aim 3 will be to compare postoperative constipation, nausea, and vomiting between the two treatment groups. This will be assessed with daily clinical examinations while in the hospital and with daily phone surveys on discharge. Constipation will be recorded as presence or absence, while nausea and vomiting will be measured using the Postoperative Nausea and Vomiting Scale.
  • Aim 4 will be to compare the length of post-surgery hospitalization between the two treatment groups.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain Levels

    Time frame: 2 weeks

    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.

Secondary outcomes

  1. Opioid Levels

    Time frame: 2 weeks

    compare the overall morphine equivalents used during hospitalization between the opioid and non-opioid treatment groups. This will be calculated based on the amount of intravenous breakthrough narcotic pain medication used in the hospital setting (divided by the total number of post-surgery hospitalization hours to account for varying lengths of stay). Investigators will also measure the total number of opioid pills (these would be placebo pills for the non-opioid group) consumed during the first two weeks post-discharge, and the post-surgery day on which opioid pills were discontinued, and compare these outcomes between the opioid and non-opioid groups.

  2. Side effects

    Time frame: 2 weeks

    compare postoperative constipation, nausea, and vomiting between the two treatment groups. This will be assessed with daily clinical examinations while in the hospital and with daily phone surveys on discharge. Constipation will be recorded as presence or absence, while nausea and vomiting will be measured using the Postoperative Nausea and Vomiting Scale. This scaled is based off 2 questions related to nausea and vomiting which will be added together for a total score. Responses range from 0 to 3 and a total score of greater than or equal to 5 will be defined as clinically important.

  3. Length of hospitalization

    Time frame: 2 weeks

    compare the length of post-surgery hospitalization between the two treatment groups.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Ambit Biosciences Corporation
  • Kern Medical Center

Registry information

Official study title

A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 19, 2019
Registry last updated
Jul 30, 2020

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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