PainPhase 4lonkkalaastaNCT02575664
Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty
A Phase 4 study testing Buprenorphine in people with Pain and Osteoarthritis, run by Kuopio University Hospital at 1 site in Finland.
Trial summary
Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1 -receptors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain, Osteoarthritis
- What is being tested?
- Buprenorphine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteFinland
- Study dates
- Aug 2012to Oct 2015
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- no pregnancy/lactation, reliable contraception before menopause
- elective knee or hip arthroplasty surgery
- BMI (=body mass index) 18-35 kg/m2
- obtained informed consent
Who cannot join
- buprenorphine medication
- allergy to study drugs• ikä < 18 tai >75 years
- BMI <18 tai>35 kg/m2
- weight below 50 kg
- Other contraindication for the study drug
Trial locations and contacts
1 site in 1 country.
About this study
Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1 -receptors. It acts as a partial agonist at the mu-opioid and as a partial agonist/antagonist at the kappa-opioid, and as an antagonist at the delta opioid receptors. Buprenorphine has up to two-fold duration of action and it is approximately 30-fold more potent when compared to morphine.
Pain is a common problem in patients coming to joint arthroplastic surgery. Buprenorphine low dose patches are recommended for treatment of moderate pain for example osteoarthritis pain. It is known that well treated pain even preoperatively may prevent prolonged postsurgical pain.
In the present study the effects of low dose buprenorphine on postoperative pain and recovery were assessed.
- Conditions
- Pain, Osteoarthritis
- Being tested
- Buprenorphine, Placebo
- Keywords
- Pain, Arthroplasty, Buprenorphine
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BuprenorphineDrug
Buprenorphine 5 microg/h/7 days
PlaceboDrug
Placebo patch
| Study group | Role | What they receive |
|---|---|---|
| Buprenorphine | Experimental | Buprenorphine 5 microg/h/7days patch Receives: Drug: Buprenorphine |
| Placebo | Placebo comparator | Placebo patch Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain relief
Brief pain inventory
Measured: time from drug patch administration up to five weeks
Prolonged pain after arthroplastic surgery
Brief pain inventory
Measured: from time from drug patch administration up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startAug 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuopio University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Responsible party
- Principal investigator, Merja Kokki, Kuopio University Hospital
- Investigators
- Merja Kokki, MD, PhD, Principal investigator, Kuopio University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575664
- Sponsor's protocol ID
- KUH2011-000692-14
- Acronym
- lonkkalaasta
- Status last verified
- Dec 2015
- First submitted
- 9 Oct 2015
- Last updated
- 29 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02575664
- Acronym / sponsor ID
- lonkkalaasta / KUH2011-000692-14
- Conditions
- Pain, Osteoarthritis
- Keywords
- Pain, Arthroplasty, Buprenorphine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Kuopio University HospitalUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Aug 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 15 Oct 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.
Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1 -receptors. It acts as a partial agonist at the mu-opioid and as a partial agonist/antagonist at the kappa-opioid, and as an antagonist at the delta opioid receptors. Buprenorphine has up to two-fold duration of action and it is approximately 30-fold more potent when compared to morphine.
Pain is a common problem in patients coming to joint arthroplastic surgery. Buprenorphine low dose patches are recommended for treatment of moderate pain for example osteoarthritis pain. It is known that well treated pain even preoperatively may prevent prolonged postsurgical pain.
In the present study the effects of low dose buprenorphine on postoperative pain and recovery were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buprenorphine | Experimental | Drug: BuprenorphineBuprenorphine 5 microg/h/7days patch |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo patch |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- no pregnancy/lactation, reliable contraception before menopause
- elective knee or hip arthroplasty surgery
- BMI (=body mass index) 18-35 kg/m2
- obtained informed consent
Key exclusion criteria (5 listed)
- buprenorphine medication
- allergy to study drugs• ikä < 18 tai >75 years
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 |
|---|---|---|
| BuprenorphineBuprenorphine 5 microg/h/7 days | Drug | Buprenorphine |
| PlaceboPlacebo patch | Drug | Placebo |
Primary outcome
Pain relief
Time frame: time from drug patch administration up to five weeks
Brief pain inventory
Prolonged pain after arthroplastic surgery
Time frame: from time from drug patch administration up to one year
Brief pain inventory
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 29 Dec 2015.
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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.
Merja Kokki, MD, PhD principal investigator
Kuopio University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Buprenorphine in people with Pain and Osteoarthritis, run by Kuopio University Hospital at 1 site in Finland.
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 4 inclusion and 5 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 29 Dec 2015. 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 Finland. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Pain relief (time frame: time from drug patch administration up to five weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Dec 2015.