Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo

St. Olavs Hospital

Status and phase: Completed; Phase 3

Conditions: Joint Diseases

Treatments: Drug: Oxycodone; Drug: Tapentadol; Drug: usual pain treatment; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02604446

2015-000295-94 (EudraCT Number)

TPO-150

Details and patient eligibility

About

This study will provide knowledge about the use of long-acting opioids for pain relief after primary knee arthroplasty. The investigators will compare depot tapentadol, depot oxycodone and placebo for effect on pain relief and side effects. The three study groups reflect the three different postoperative pain regimens that have been used the last years at St. Olavs Hospital, so investigators know that no patient will receive an inadequate pain treatment. The purpose of the study is to find which of the three treatments that gives the best pain relief with the least amount of side effects. The results will be of use for postoperative pain treatment for knee arthroplasty, but also for other types of major surgery. Similar studies that are not sponsored by pharmaceutical industry have not been published yet.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• scheduled for knee arthroplasty at St. Olavs University Hospital
• consent in participation in the study

Exclusion criteria

• Contraindications for any of the study drugs
• Lactose intolerance
• Known hypersensitivity against any of the additives
• Chronic Obstructive Pulmonary Disease (COPD) grade 3 or 4
• Paralytic ileus
• Known alcohol or medical addiction/abuse
• History of asthma, urticaria or allergic reaction caused by acetyl salicylic acid or other NSAIDs
• Peptic ulcer
• Hemophilia
• Gastrointestinal bleeding
• Cerebrovascular bleeding
• Inflammatory bowel disease (ulcerous colitis, Crohn disease)
• Concomitant use of the following drugs: ACE-inhibitors, AT2-blockers, SSRI, Anti-psychotic drugs, MAO-inhibitors, Atazanavir and Nelfinavir (medicine used for HIV-infection)
• Known kidney failure (creatinin level above reference value)
• Known heart failure (NYHA III-IV)
• Pregnancy
• Women in fertile age with risk of pregnancy
• Nursing women
• operated under general anesthesia without use of spinal anesthesia
• using opioids on a regular basis except users of codeine or tramadol, or known former abuse of opioids
• Cognitive failure or other factors which make follow up impossible (for example language difficulties)
• No cell phone or internet connection at home (making follow up difficult)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 3 patient groups, including a placebo group

Tapentadol

Experimental group

Description:

depot Tapentadol in addition to usual pain treatment

Treatment:

Drug: usual pain treatment

Drug: Tapentadol

Oxycodone

Active Comparator group

Description:

depot Oxycodone in addition to usual pain treatment

Treatment:

Drug: usual pain treatment

Drug: Oxycodone

Placebo

Placebo Comparator group

Description:

depot glucose placebo in addition to usual pain treatment.

Treatment:

Drug: Placebo

Drug: usual pain treatment