Efficacy And Safety Of Tramadol And Oxycodone Versus Oxycodone Monotherapy For Pain Control After Primary Total Knee And Total Hip Arthroplasty

Mayo Clinic

Status and phase: Not yet enrolling; Phase 4

Conditions: Post Operative Pain

Treatments: Drug: Tramadol and Oxycodone; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT07153003

25-002295

Details and patient eligibility

About

The purpose of this study is to evaluate the effectiveness and safety of tramadol and oxycodone therapy in comparison to oxycodone alone as part of a multimodal pain regimen to reduce postoperative opioid consumption, pain, minimize adverse events and complications for primary total knee arthroplasty (TKA) and primary total hip arthroplasty (THA).

Enrollment: 560 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary TKA
• Primary THA
• Age > 18 years

Exclusion criteria

• Age < 18 years
• Revision or partial TKA/THA
• Pregnant or breast-feeding women
• Simultaneous bilateral TKA/THA
• Primary TKA/THA due to oncologic reason
• Anaphylaxis to opioids
• Renal or liver failure
• Prior opioid use disorder/ substance use disorder
• Opioid use within 3 months prior to surgery
• Patients needing a translator and those with dementia or other cognitive deficits
• Patients taking Monoamine Oxidase Inhibitor (MOAI) medications (phenelzine, tranylcypromine) or benzodiazepine medications (alprazolam, diazepam, lorazepam, etc)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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560 participants in 2 patient groups

Oxycodone Only

Active Comparator group

Description:

Patient's will be prescribed only Oxycodone for post operative pain management.

Treatment:

Drug: Oxycodone

Multimodal Pain Control

Active Comparator group

Description:

Patients will be prescribed Tramadol and Oxycodone for post operative opioid pain relief.

Treatment:

Drug: Tramadol and Oxycodone