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

November 10, 2021 updated by: St. Olavs Hospital

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

134

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway
        • Anestesiavdelingen, St Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Tapentadol
depot Tapentadol in addition to usual pain treatment
Drug: Tapentadol
Other Names:
  • 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 Names:
  • 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 Names:
  • Glucose
Drug: usual pain treatment
premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain at rest in the previous 24 hours
Time Frame: 8 days
NRS-scores 1-10 scale
8 days
worst pain in the previous 24 hours
Time Frame: 8 days
NRS-scores 1-10 scale
8 days
quality of sleep in the previous night
Time Frame: 8 days
NRS-scores 1-10 scale
8 days
nausea in the previous 24 hours
Time Frame: 8 days
NRS-scores 1-10 scale
8 days
obstipation in the previous 24 hours
Time Frame: 8 days
NRS-scores 1-10 scale
8 days
dizziness in the previous 24 hours
Time Frame: 8 days
NRS-scores 1-10 scale
8 days
sedation in the previous 24 hours
Time Frame: 8 days
NRS-scores 1-10 scale
8 days
headache
Time Frame: 8 days in the previous 24 hours
NRS-scores 1-10 scale
8 days in the previous 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (ACTUAL)

February 1, 2019

Study Completion (ACTUAL)

February 1, 2019

Study Registration Dates

First Submitted

November 11, 2015

First Submitted That Met QC Criteria

November 12, 2015

First Posted (ESTIMATE)

November 13, 2015

Study Record Updates

Last Update Posted (ACTUAL)

November 16, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPO-150
  • 2015-000295-94 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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