Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty
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ClinicalTrials.gov Identifier: NCT03845881 |
Recruitment Status :
Completed
First Posted : February 19, 2019
Last Update Posted : July 30, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Total Knee Arthroplasty | Drug: Oxycodone Drug: Placebo Oral Tablet | Early Phase 1 |
- 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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 45 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Multi-Modal Pain Protocol with and without Opioids Following Total Joint Arthroplasty |
Masking: | Double (Participant, Investigator) |
Masking Description: | The oxycodone and placebo tablets will be encapsulated by the research pharmacy prior to dispensing for blinding purposes. |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blinded, Placebo-Controlled Trial Comparing a Multi-Modal Pain Protocol With and Without Opioids Following Total Joint Arthroplasty |
Actual Study Start Date : | April 10, 2019 |
Actual Primary Completion Date : | July 28, 2020 |
Actual Study Completion Date : | July 28, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Opioid
Multi-Modal Pain Protocol with Opioids Following Total Joint Arthroplasty
|
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. |
Placebo Comparator: Non Opioid
Multi-Modal Pain Protocol without Opioids Following Total Joint Arthroplasty
|
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. |
- 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.
- 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.
- 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.
- Length of hospitalization [ Time Frame: 2 weeks ]compare the length of post-surgery hospitalization between the two treatment groups.

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Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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): NCT03845881
United States, Florida | |
Mayo Clinic in Florida | |
Jacksonville, Florida, United States, 32224 |
Principal Investigator: | Benjamin Wilke, MD | Mayo Clinic |
Responsible Party: | Benjamin K. Wilke, Principal Investigator, Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT03845881 |
Other Study ID Numbers: |
18-004256 |
First Posted: | February 19, 2019 Key Record Dates |
Last Update Posted: | July 30, 2020 |
Last Verified: | July 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Oxycodone Analgesics, Opioid Narcotics Central Nervous System Depressants |
Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents |