The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04003350 |
Recruitment Status :
Completed
First Posted : July 1, 2019
Last Update Posted : July 1, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
It is well recognized that a multimodal analgesia program targeting multiple pain pathways, is more effective for controlling pain during the hospital stay and in the acute postoperative period than monotherapy-based regimens, such as opioids only. This multimodal analgesic regimen also leads to reduce opioid consumption and its related side effects after hip and knee joint replacement procedures. One potential strategy to reduce the use of opioids after TKA is to administer a prolonged oral multimodal pain regimen that targets multiple pain pathways in the post hospital discharge period. This can be equal or more effective than the regimen of opioid prescriptions used after TKA. To the best of our knowledge, there have been no studies conducted that directly examine the effect of prolonged multimodal pain regimen after hospital discharge in primary TKA patients.
PURPOSE:
- To determine whether a prolonged multimodal pain regimen after discharge from primary TKA can provide equivalent or better pain control while reducing opioid consumption and, subsequently, opioid-related side effects.
- To determine whether patient expectations and routine opioid prescription practices at the time of discharge from primary TKA impacts opioid consumption.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteo Arthritis Knee | Drug: Oxycodone Drug: Tramadol Drug: Tylenol Drug: Meloxicam Drug: Gabapentin Drug: Metaxalone Drug: Esomeprazole 20mg | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 216 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Prolonged Multimodal Analgesic Regimen on Post Hospital Discharge Opioid Use and Pain Control After Primary Total Knee Arthroplasty |
Actual Study Start Date : | December 21, 2017 |
Actual Primary Completion Date : | November 26, 2018 |
Actual Study Completion Date : | March 15, 2019 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Opioid Regimen
Weeks 1-4
|
Drug: Oxycodone
Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets) Drug: Tramadol Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets) |
Experimental: Multimodal pain regimen with PRN opioids
Weeks 1-4
|
Drug: Oxycodone
Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets) Drug: Tramadol Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets) Drug: Tylenol Tylenol 1000 mg: take as needed every 8 hours Drug: Meloxicam Meloxicam 15 mg as need once per day Drug: Gabapentin •Gabapentin 200 mg with morning and evening Tylenol dose Drug: Metaxalone Metaxalone 800mg TID Drug: Esomeprazole 20mg Esomeprazole 20mg daily |
- Post-operative pain [ Time Frame: Postsurgery days 1-30 ]Measured via Visual Analog scale (0-100mm)
- Opioid related side effects [ Time Frame: post-surgery days 1-30 ]Severity measured via Visual Analog scale (0-100mm)
- opioid consumption [ Time Frame: post-surgery weeks 1-4 ]morphine milligram equivalent
- opioid consumption [ Time Frame: post-surgery weeks 1-4 ]number of pills consumed
- number of opioid refills [ Time Frame: post-surgery weeks 1-4 ]number of times subjects asked to have an opioid prescription refilled during post-operative period
- 90 day complications [ Time Frame: post-surgery 90 days ]collection of all post-operative medical complications within the first 90 days after surgery

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients undergoing unilateral primary TKA with underlying diagnosis of osteoarthritis.
- ASA I - III
- Spinal anesthesia
- All patients will have cemented total knee utilizing a medial parapatellar approach including patellar resurfacing. A tourniquet will be used in all cases
- Male and Female over 18 who are willing and able to provide informed consent
Exclusion Criteria:
- Opioid use within 3 months preoperatively
- Inability to take the protocol medications
- Anticoagulant other than aspirin
- Contraindication to regional anesthesia
- Non-english speaking
- ASA IV or greater
- Psychiatric or cognitive disorders
- Allergy/contraindications to protocol medications.
- Renal insufficiency with Cr > 2.0 or hepatic failure
- General anesthesia
- Sensory/motor disorder involving the operative limb

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): NCT04003350
United States, Pennsylvania | |
Rothman Institute | |
Philadelphia, Pennsylvania, United States, 19148 |
Responsible Party: | Rothman Institute Orthopaedics |
ClinicalTrials.gov Identifier: | NCT04003350 |
Other Study ID Numbers: |
2019MAUSTKA |
First Posted: | July 1, 2019 Key Record Dates |
Last Update Posted: | July 1, 2019 |
Last Verified: | June 2019 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Osteoarthritis Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Acetaminophen Meloxicam Oxycodone Tramadol Gabapentin Esomeprazole Metaxalone Analgesics, Opioid Narcotics |
Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Anticonvulsants Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antimanic Agents Anti-Ulcer Agents |