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Completed

NCT Number: NCT02604446

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

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.

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Key information

Conditions

Joint Diseases Agnosia Musculoskeletal Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Anestesiavdelingen, St Olavs Hospital

Trondheim, Norway

Who can participate

Healthy volunteers accepted: No

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

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)

Treatment and study plan

Tapentadol

Drug

Other names: Palexia Depot

Oxycodone

Drug

Other names: Oxycontin

Placebo

Drug

Other names: Glucose

usual pain treatment

Drug

premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo

Primary outcomes

  1. Area under curve (AUC) based on daily numeric rating score (NRS) scale 1-10 for pain by mobilization the first 8 postoperative days

    Time frame: 8 days

    NRS-scores

Secondary outcomes

  1. Pain at rest in the previous 24 hours

    Time frame: 8 days

    NRS-scores 1-10 scale

  2. worst pain in the previous 24 hours

    Time frame: 8 days

    NRS-scores 1-10 scale

  3. quality of sleep in the previous night

    Time frame: 8 days

    NRS-scores 1-10 scale

  4. nausea in the previous 24 hours

    Time frame: 8 days

    NRS-scores 1-10 scale

  5. obstipation in the previous 24 hours

    Time frame: 8 days

    NRS-scores 1-10 scale

  6. dizziness in the previous 24 hours

    Time frame: 8 days

    NRS-scores 1-10 scale

  7. sedation in the previous 24 hours

    Time frame: 8 days

    NRS-scores 1-10 scale

  8. headache

    Time frame: 8 days in the previous 24 hours

    NRS-scores 1-10 scale

Sponsors and collaborators

Lead sponsor

St. Olavs Hospital

Other

Registry information

Official study title

Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty. A Double Blinded Randomized Controlled Study. Tapentadol vs Oxycodone vs Placebo

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Nov 13, 2015
Registry last updated
Nov 16, 2021

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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