Arthroplasty, Knee ReplacementNCT01226186
Self Medication With Oral Morphine After Total Knee Arthroplasty.
A study testing Nurse dispensed oral morphine. and Patient self medication of oral morphine. in people with Arthroplasty, Knee Replacement and Pain Control, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
Trial summary
The study aims to compare two post operative pain management strategy's, traditional nurse dispensed pain control versus patient self medication. The investigators aim to establish if patients who self medicate have differing pain levels than those who take nurse dispensed oral morphine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Knee Replacement, Pain Control
- What is being tested?
- Nurse dispensed oral morphine. and Patient self medication of oral morphine.
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2010to Jun 2011
- Phase
- Interventional
- 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
- Patients requiring total knee replacement surgery willing to provide written, informed consent.
Who cannot join
- Unable to safely self medicate.
- Allergy to morphine.
- Unable to provide consent.
- Contraindication to the standardised anaesthetic or standard postoperative care.
- Not consenting to an element of the standardised anaesthetic.
- Pre-operative use of strong opiates e.g. Oramorph, MST, Oxynorm.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Derwent Unit, Royal Bournemouth Hospital.
Bournemouth, Dorset., BH7 7DW
About this study
Official title: Self Medication With Oral Morphine After Total Knee Arthroplasty. A Randomised Controlled Trial Comparing Self Medication With Standard Nurse Dispensing. Is There a Difference in Morphine Consumption, Pain, Patient Satisfaction or Safety?
The study aims to compare two post operative pain management strategy's, traditional nurse dispensed pain control versus patient self medication. The investigators aim to establish if patients who self medicate have differing pain levels than those who take nurse dispensed oral morphine.
- Conditions
- Arthroplasty, Knee Replacement, Pain Control
- Being tested
- Nurse dispensed oral morphine., Patient self medication of oral morphine.
- Keywords
- Knee replacement, Pain control, Self medication
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse dispensed oral morphine.Behavioural
Nurse will dispense oral morphine on request from the patient.
Patient self medication of oral morphine.Behavioural
Patients will self medicate their oral morphine pain control solution following surgery.
| Study group | Role | What they receive |
|---|---|---|
| Nurse dispensed oral morphine solution. | Active comparator | Not described Receives: Behavioral: Nurse dispensed oral morphine. |
| Self medicated oral morphine solution. | Active comparator | Not described Receives: Behavioral: Patient self medication of oral morphine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish if patients who self medicate with oral morphine have differing pain levels than those who take nurse dispensed oral morphine.
Measured: one year
Secondary outcomes (2)
To identify if patients who self medicate with oral morphine take a significantly different amount of morphine compared with those who take nurse dispensed oral morphine.
Measured: one year
To compare whether patients who self medicate with oral morphine have a significantly altered level of side effects compared with those who take nurse dispensed oral morphine.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Knee ReplacementStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Bournemouth Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Jonathan Linton, Doctor, Principal investigator, Poole Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226186
- Sponsor's protocol ID
- 10/H0505/77
- Status last verified
- Dec 2012
- First submitted
- 21 Oct 2010
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self Medication With Oral Morphine After Total Knee Arthroplasty. A Randomised Controlled Trial Comparing Self Medication With Standard Nurse Dispensing. Is There a Difference in Morphine Consumption, Pain, Patient Satisfaction or Safety?
- ClinicalTrials.gov ID
- NCT01226186
- Acronym / sponsor ID
- 10/H0505/77
- Conditions
- Arthroplasty, Knee Replacement, Pain Control
- Keywords
- Knee replacement, Pain control, Self medication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- The Royal Bournemouth HospitalUniversity, hospital or other
- Collaborators
- Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
- Study start
- Oct 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Oct 2010 (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.
The study aims to compare two post operative pain management strategy's, traditional nurse dispensed pain control versus patient self medication. The investigators aim to establish if patients who self medicate have differing pain levels than those who take nurse dispensed oral morphine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nurse dispensed oral morphine solution. | Active comparator | Behavioral: Nurse dispensed oral morphine. |
| Self medicated oral morphine solution. | Active comparator | Behavioral: Patient self medication of oral morphine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients requiring total knee replacement surgery willing to provide written, informed consent.
Key exclusion criteria (6 listed)
- Unable to safely self medicate.
- Allergy to morphine.
- Unable to provide consent.
- Contraindication to the standardised anaesthetic or standard postoperative care.
- Not consenting to an element of the standardised anaesthetic.
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 |
|---|---|---|
| Nurse dispensed oral morphine.Nurse will dispense oral morphine on request from the patient. | Behavioural | Nurse dispensed oral morphine solution. |
| Patient self medication of oral morphine.Patients will self medicate their oral morphine pain control solution following surgery. | Behavioural | Self medicated oral morphine solution. |
Primary outcome
To establish if patients who self medicate with oral morphine have differing pain levels than those who take nurse dispensed oral morphine.
Time frame: one year
2 secondary outcomes
To identify if patients who self medicate with oral morphine take a significantly different amount of morphine compared with those who take nurse dispensed oral morphine.
Time frame: one year
To compare whether patients who self medicate with oral morphine have a significantly altered level of side effects compared with those who take nurse dispensed oral morphine.
Time frame: one year
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 4 Dec 2012.
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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.
Jonathan Linton, Doctor principal investigator
Poole Hospital NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse dispensed oral morphine. and Patient self medication of oral morphine. in people with Arthroplasty, Knee Replacement and Pain Control, run by The Royal Bournemouth Hospital at 1 site in United Kingdom.
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 1 inclusion and 6 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 4 Dec 2012. 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 United Kingdom. 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.
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?
To establish if patients who self medicate with oral morphine have differing pain levels than those who take nurse dispensed oral morphine. (time frame: one year). 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 4 Dec 2012.