Joint DiseasesPhase 3NCT02604446
Depot-opioids for Pre- and Postoperative Pain Relief After Primary Knee Arthroplasty.Tapentadol vs Oxycodone vs Placebo
A Phase 3 study testing Tapentadol, Oxycodone and usual pain treatment in people with Joint Diseases, run by St. Olavs Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Joint Diseases
- What is being tested?
- Tapentadol, Oxycodone and usual pain treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2015to Feb 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- scheduled for knee arthroplasty at St. Olavs University Hospital
- consent in participation in the study
Who cannot join
- 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
Show all 22Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Joint Diseases
- Being tested
- Tapentadol, Oxycodone, Placebo, usual pain treatment
- Keywords
- Arthroplasty, Replacement, Knee, Analgesics, Administration and dosage, Knee, Postoperational care, Pain management
- Medical subject headings
- Joint Diseases, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TapentadolDrug
Also called Palexia Depot
OxycodoneDrug
Also called Oxycontin
PlaceboDrug
Also called Glucose
usual pain treatmentDrug
premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo
| Study group | Role | What they receive |
|---|---|---|
| Tapentadol | Experimental | depot Tapentadol in addition to usual pain treatment Receives: Drug: Tapentadol; Drug: usual pain treatment |
| Oxycodone | Active comparator | depot Oxycodone in addition to usual pain treatment Receives: Drug: Oxycodone; Drug: usual pain treatment |
| Placebo | Placebo comparator | depot glucose placebo in addition to usual pain treatment. Receives: Drug: Placebo; Drug: usual pain treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under curve (AUC) based on daily numeric rating score (NRS) scale 1-10 for pain by mobilization the first 8 postoperative days
NRS-scores
Measured: 8 days
Secondary outcomes (8)
Pain at rest in the previous 24 hours
NRS-scores 1-10 scale
Measured: 8 days
worst pain in the previous 24 hours
NRS-scores 1-10 scale
Measured: 8 days
quality of sleep in the previous night
NRS-scores 1-10 scale
Measured: 8 days
nausea in the previous 24 hours
NRS-scores 1-10 scale
Measured: 8 days
obstipation in the previous 24 hours
NRS-scores 1-10 scale
Measured: 8 days
dizziness in the previous 24 hours
NRS-scores 1-10 scale
Measured: 8 days
sedation in the previous 24 hours
NRS-scores 1-10 scale
Measured: 8 days
headache
NRS-scores 1-10 scale
Measured: 8 days in the previous 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startSep 2015
- Primary completionFeb 2019
- Study completionFeb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Joint DiseasesStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Petter Aadahl, md phd, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02604446
- Sponsor's protocol ID
- TPO-150
- Other IDs
- 2015-000295-94, 2015
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2015
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Rian T, Skogvoll E, Hofstad J, Hovik L, Winther SB, Husby VS, Klaksvik J, Egeberg T, Sand K, Klepstad P, Wik TS. Tapentadol vs oxycodone for postoperative pain treatment the first 7 days after total knee arthroplasty: a randomized clinical trial. Pain. 2021 Feb 1;162(2):396-404. doi: 10.1097/j.pain.0000000000002026.
PubMed 32773594Rian T, Sand K, Skogvoll E, Klepstad P, Wik TS. A Web-Based Communication Tool for Postoperative Follow-up and Pain Assessment at Home After Primary Knee Arthroplasty: Feasibility and Usability Study. JMIR Form Res. 2022 Apr 28;6(4):e34543. doi: 10.2196/34543.
PubMed 35482392
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02604446
- Acronym / sponsor ID
- TPO-150
- Conditions
- Joint Diseases
- Keywords
- Arthroplasty, Replacement, Knee, Analgesics, Administration and dosage, Knee, Postoperational care, Pain management
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Feb 2019 (actual)
- Study completion
- Feb 2019 (actual)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tapentadol | Experimental | Drug: Tapentadol, Drug: usual pain treatmentdepot Tapentadol in addition to usual pain treatment |
| Oxycodone | Active comparator | Drug: Oxycodone, Drug: usual pain treatmentdepot Oxycodone in addition to usual pain treatment |
| Placebo | Placebo comparator | Drug: Placebo, Drug: usual pain treatmentdepot glucose placebo in addition to usual pain treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- scheduled for knee arthroplasty at St. Olavs University Hospital
- consent in participation in the study
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TapentadolAlso: Palexia Depot | Drug | Tapentadol |
| OxycodoneAlso: Oxycontin | Drug | Oxycodone |
| PlaceboAlso: Glucose | Drug | Placebo |
| usual pain treatmentpremedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo | Drug | Oxycodone, Placebo, Tapentadol |
Primary outcome
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 secondary outcomes
Pain at rest in the previous 24 hours
Time frame: 8 days
worst pain in the previous 24 hours
Time frame: 8 days
quality of sleep in the previous night
Time frame: 8 days
nausea in the previous 24 hours
Time frame: 8 days
obstipation in the previous 24 hours
Time frame: 8 days
dizziness in the previous 24 hours
Time frame: 8 days
sedation in the previous 24 hours
Time frame: 8 days
headache
Time frame: 8 days in the previous 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2021.
- Results publication: PubMed 32773594Rian T, Skogvoll E, Hofstad J, Hovik L, Winther SB, Husby VS, Klaksvik J, Egeberg T, Sand K, Klepstad P, Wik TS. Tapentadol vs oxycodone for postoperative pain treatment the first 7 days after total knee arthroplasty: a randomized clinical trial. Pain. 2021 Feb 1;162(2):396-404. doi: 10.1097/j.pain.0000000000002026.
- Derived from this study: PubMed 35482392Rian T, Sand K, Skogvoll E, Klepstad P, Wik TS. A Web-Based Communication Tool for Postoperative Follow-up and Pain Assessment at Home After Primary Knee Arthroplasty: Feasibility and Usability Study. JMIR Form Res. 2022 Apr 28;6(4):e34543. doi: 10.2196/34543.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petter Aadahl, md phd study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tapentadol, Oxycodone and usual pain treatment in people with Joint Diseases, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02604446, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2021.