Pain, PostoperativePhase 4NCT03434951
Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty
A Phase 4 study testing Bupivacaine Hydrochloride, Spinal and Morphine hydrochloride, Spinal in people with Pain, Postoperative, run by South Carelia Central Hospital at 1 site in Finland.
Trial summary
Double-blinded randomized control study investigating intrathecal morphine as an additive to spinal anesthesia in patients undergoing elective total knee arthroplasty. The investigators aim to include a total of 120 patients, randomized to two equal groups. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Bupivacaine Hydrochloride, Spinal and Morphine hydrochloride, Spinal
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 6 Nov 2017to 1 Sep 2020
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective primary total knee arthroplasty
- ASA I-III
- written consent
Who cannot join
- rearthroplasty
- ASA IV-V
- inadequate spoken finnish for reliable pain assessment
- Dementia or otherwise impaired cognition
- contraindication for any medication or substance used in survey protocol
- weight <50kg or BMI ≥35 kg/m2
Show all 10Show fewer
- preoperative SpO2 less than 93%
- clinical suspicion that subject can not use PCA adequately
- history of substance abuse or current excessive use of alcohol
- preoperative use of either pregabalin, gabapentin or strong opiates
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
South Carelia Central Hospital
Lappeenranta, 53130
Susanna Niinimäki, BSc, SRN /Anesthesia, +358406511388, Susanna.niinimaki@eksote.fi
MD, PhD
About this study
Official title: Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty, a Randomized Controlled Study
Double-blinded randomized control study investigating intrathecal morphine as an additive to spinal anesthesia in patients undergoing elective total knee arthroplasty. The investigators aim to include a total of 120 patients, randomized to two equal groups. Participants in the intervention group are administered intrathecal 0,2mg morphine and 12,5mg bupivacaine for spinal anaesthesia. Participants in the placebo group are administered 12.5mg bupivacaine and saline to match the volume of intervention goup. Primary end points are opioid consumption and possible adverse effects.
- Conditions
- Pain, Postoperative
- Being tested
- Bupivacaine Hydrochloride, Spinal, Morphine hydrochloride, Spinal, Placebo - Concentrate
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Hydrochloride, SpinalDrug
Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia
Morphine hydrochloride, SpinalDrug
Intrathecally administered morphine 0,2mg (2mg/ml, 0,1ml)
Placebo - ConcentrateDrug
Also called physiologic saline solution
Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume
| Study group | Role | What they receive |
|---|---|---|
| Intrathecal morphine and bupivacaine | Experimental | 0,2mg intrathecal morphine and 12,5mg bupivacaine administered Receives: Drug: Bupivacaine Hydrochloride, Spinal; Drug: Morphine hydrochloride, Spinal |
| Placebo | Active comparator | 12,5mg bupivacaine and NaCl 0,9% to match the same volume administered Receives: Drug: Bupivacaine Hydrochloride, Spinal; Drug: Placebo - Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
intravenous oxycodone consumption
Cumulative postoperative consumption
Measured: 48 hours
Secondary outcomes (3)
Adverse effects of 0,2mg intrathecal morphine
Possible nausea, vomiting, itching and respiratory depression
Measured: 48 hours
Mobilization time
Assessing the time to ambulation
Measured: 48 hours
Patient satisfaction
Telephone interview 28 days after surgery
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start6 Nov 2017
- Primary completion1 Sep 2019 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Carelia Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Susanna Niinimäki, South Carelia Central Hospital
- Investigators
- Seppo Mustola, MD, PhD, Study director, South Carelia Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434951
- Sponsor's protocol ID
- KNEMO 01
- Status last verified
- Feb 2018
- First submitted
- 10 Dec 2017
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty, a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03434951
- Acronym / sponsor ID
- KNEMO 01
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- South Carelia Central HospitalUniversity, hospital or other
- Study start
- 6 Nov 2017 (actual)
- Primary completion
- 1 Sep 2019 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 15 Feb 2018 (actual)
- 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.
Double-blinded randomized control study investigating intrathecal morphine as an additive to spinal anesthesia in patients undergoing elective total knee arthroplasty. The investigators aim to include a total of 120 patients, randomized to two equal groups. Participants in the intervention group are administered intrathecal 0,2mg morphine and 12,5mg bupivacaine for spinal anaesthesia. Participants in the placebo group are administered 12.5mg bupivacaine and saline to match the volume of intervention goup. Primary end points are opioid consumption and possible adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intrathecal morphine and bupivacaine | Experimental | Drug: Bupivacaine Hydrochloride, Spinal, Drug: Morphine hydrochloride, Spinal0,2mg intrathecal morphine and 12,5mg bupivacaine administered |
| Placebo | Active comparator | Drug: Bupivacaine Hydrochloride, Spinal, Drug: Placebo - Concentrate12,5mg bupivacaine and NaCl 0,9% to match the same volume administered |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective primary total knee arthroplasty
- ASA I-III
- written consent
Key exclusion criteria (10 listed)
- rearthroplasty
- ASA IV-V
- inadequate spoken finnish for reliable pain assessment
- Dementia or otherwise impaired cognition
- contraindication for any medication or substance used in survey protocol
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 |
|---|---|---|
| Bupivacaine Hydrochloride, SpinalIntrathecally administered 12,5mg bupivacaine for spinal anaesthesia | Drug | Intrathecal morphine and bupivacaine, Placebo |
| Morphine hydrochloride, SpinalIntrathecally administered morphine 0,2mg (2mg/ml, 0,1ml) | Drug | Intrathecal morphine and bupivacaine |
| Placebo - ConcentrateAlso: physiologic saline solutionIntrathecally administered saline solution 0,9% 0,1ml to match morphine volume | Drug | Placebo |
Primary outcome
intravenous oxycodone consumption
Time frame: 48 hours
Cumulative postoperative consumption
3 secondary outcomes
Adverse effects of 0,2mg intrathecal morphine
Time frame: 48 hours
Mobilization time
Time frame: 48 hours
Patient satisfaction
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Individual participant dataSharing planned: No
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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.
Seppo Mustola, MD, PhD study director
South Carelia Central 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 Bupivacaine Hydrochloride, Spinal and Morphine hydrochloride, Spinal in people with Pain, Postoperative, run by South Carelia Central 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 15 Feb 2018. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Susanna Niinimäki, BSc, SRN /Anesthesia (+358406511388, susanna.niinimaki@eksote.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intravenous oxycodone consumption (time frame: 48 hours). 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 15 Feb 2018; AzTrials last refreshed its copy on 8 Nov 2026.