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

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ClinicalTrials.gov Identifier: NCT02604446
Recruitment Status : Recruiting
First Posted : November 13, 2015
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Joint Diseases Drug: Tapentadol Drug: Oxycodone Drug: Placebo Drug: usual pain treatment Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty. A Double Blinded Randomized Controlled Study. Tapentadol vs Oxycodone vs Placebo
Study Start Date : September 2015
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Tapentadol
depot Tapentadol in addition to usual pain treatment
Drug: Tapentadol
Other Name: Palexia Depot

Drug: usual pain treatment
premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo

Active Comparator: Oxycodone
depot Oxycodone in addition to usual pain treatment
Drug: Oxycodone
Other Name: Oxycontin

Drug: usual pain treatment
premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo

Placebo Comparator: Placebo
depot glucose placebo in addition to usual pain treatment.
Drug: Placebo
Other Name: Glucose

Drug: usual pain treatment
premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

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): NCT02604446


Contacts
Contact: Torbjørn Rian, md Torbjorn.Rian@stolav.no
Contact: Jan Gunnar Skogås, md phd? Jan.Gunnar.Skogas@stolav.no

Locations
Norway
Anestesiavdelingen, St Olavs Hospital Recruiting
Trondheim, Norway
Contact: Thorbjørn Rian, md       Torbjorn.Rian@stolav.no   
Sponsors and Collaborators
St. Olavs Hospital
Investigators
Study Director: Petter Aadahl, md phd St. Olavs Hospital

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT02604446     History of Changes
Other Study ID Numbers: TPO-150
2015-000295-94 ( EudraCT Number )
First Posted: November 13, 2015    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018

Keywords provided by St. Olavs Hospital:
Arthroplasty, Replacement, Knee
Analgesics
Administration and dosage
Knee
Postoperational care
Pain management

Additional relevant MeSH terms:
Pain, Postoperative
Joint Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Musculoskeletal Diseases
Oxycodone
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents