Pain, PostoperativeNCT03135470
Pain Medication After Ambulatory Surgery
An observational study of Pain, Postoperative and Medication Adherence, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
In Finland, there are no guidelines concerning post-operative pain medication of ambulatory surgery patients. There is a wide variety in drug prescription and medication practices of various doctors and clinics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Medication Adherence, Adverse Drug Event
- How many people
- 146 participants
- Where
- 1 siteFinland
- Study dates
- 3 Apr 2017to 11 Feb 2020
- Phase
- Observational
- 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
Study population: Patients operated as ambulatory surgery patients in our clinic (orthopaedics, urology) during 3 month study periods (three 3 month phases)
Who may be able to join
- All plenipotentiary patients, operated as ambulatory surgery patients in our clinic during the study period, with informed consent
Who cannot join
- We do not accept patients, who are not plenipotentiary (minor, incompetent, prisoners, conscript in military service) or do not understand finnish or swedish written information
Trial locations and contacts
1 site in 1 country.
Finland1 site
Helsinki University (Central) Hospital, Peijas Hospital
Vantaa, 00029
About this study
Official title: Adequacy and Adverse Effects of Pain Medication After Ambulatory Surgery, Observational Study
In Finland, there are no guidelines concerning post-operative pain medication of ambulatory surgery patients. There is a wide variety in drug prescription and medication practices of various doctors and clinics. To treat patients' pain safely, type of surgery, unique patient needs, risks, adverse effects and patient's capacity to follow instructions should be assessed during the few hour visit at the clinic. In many clinics, pain is treated after hospital discharge with strong opioid oxycodone, but the amount and dose of prescribed oxycodone varies. In Helsinki Universitys Hospital, Peijas Hospital, investigators have over 2000 ambulatory surgery procedures annually. Investigators have strict policy in oxycodone use after patient discharge compared to some other Finnish ambulatory surgery clinics. The aim of this study is to evaluate, whether the prescribed pain medication is sufficient and whether patients' suffer from adverse effects after discharge from ambulatory surgery (letter interview). The study proceeds in three phases: 1) observation of current medication practice, 2) observation after optimization and standardization of hospitals drug prescription protocol, 3) evaluation of mobile phone app in pain medication follow up.
Read the detailed description
After informed consent, all patients operated as ambulatory surgery patients during the study period are given a letter interview for pain, pain medication and symptom follow up. They are also given a return envelope (with paid postal fee) to return the interview.
Based on the results of the first interview phase, our pain medication practice is reconsidered by anesthetists and surgeons to create a standard operating protocol for pain medication. The standard operating protocol is informed to personnel. Then, patient interview phase is repeated for another 3 months.
Then, investigators continue with a pilot study on using a mobile phone app in evaluating patients pain, sufficient pain medication and adverse effects. All patient with informed consent, suitable mobile phone, and willing to use it for reporting pain for hospital personnel are contacted via the mobile app. Other patients operated during that study period are interviewed by either letter interview or phone interview. Investigators try to estimate whether mobile apps are suitable for pain and medication follow-up.
- Keywords
- pain, ambulatory surgery, oxycodone, adverse effect
- Medical subject headings
- Pain, Postoperative, Medication Adherence, Drug-Related Side Effects and Adverse Reactions, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Current practice group | All plenipotentiary ambulatory surgery patients, with informed consent, during the three month study period | |
| Standard operating protocol group | All plenipotentiary ambulatory surgery patients, with informed consent, during the three month study period after creating and informing standardized operating protocol | |
| Mobile phone app group | All plenipotentiary ambulatory surgery patients during the three month study period with informed consent to use mobile phone app in assesment of pain and pain medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medication
all pain medication used (reported By the patient)
Measured: up to two days after surgery
Pain
Pain assessed By the patient By numerical rating scale 0-10
Measured: up to two days after surgery
Adverse effects
Adverse effects of the pain medication, study questions
Measured: up to two days after surgery
Sufficiency of pain medication
Whether the pain medication used was sufficient or not, study questions
Measured: up to two days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start3 Apr 2017
- Primary completion11 Feb 2020
- Study completion11 Feb 2020
Why it stopped: Phase II recruitment unsuccesful, phase III lacking personnel resources
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noora Skants, Helsinki University Central Hospital
- Investigators
- Elina Reponen, MD/PhD, Principal investigator, Senior physician, Deputy Chief of Department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135470
- Sponsor's protocol ID
- HUS235/2017
- Status last verified
- Jul 2020
- First submitted
- 23 Apr 2017
- Last updated
- 30 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adequacy and Adverse Effects of Pain Medication After Ambulatory Surgery, Observational Study
- ClinicalTrials.gov ID
- NCT03135470
- Acronym / sponsor ID
- HUS235/2017
- Keywords
- pain, ambulatory surgery, oxycodone, adverse effect
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Phase II recruitment unsuccesful, phase III lacking personnel resources
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 11 Feb 2020 (actual)
- Study completion
- 11 Feb 2020 (actual)
- First posted
- 1 May 2017 (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.
In Finland, there are no guidelines concerning post-operative pain medication of ambulatory surgery patients. There is a wide variety in drug prescription and medication practices of various doctors and clinics. To treat patients' pain safely, type of surgery, unique patient needs, risks, adverse effects and patient's capacity to follow instructions should be assessed during the few hour visit at the clinic. In many clinics, pain is treated after hospital discharge with strong opioid oxycodone, but the amount and dose of prescribed oxycodone varies. In Helsinki Universitys Hospital, Peijas Hospital, investigators have over 2000 ambulatory surgery procedures annually. Investigators have strict policy in oxycodone use after patient discharge compared to some other Finnish ambulatory surgery clinics. The aim of this study is to evaluate, whether the prescribed pain medication is sufficient and whether patients' suffer from adverse effects after discharge from ambulatory surgery (letter interview). The study proceeds in three phases: 1) observation of current medication practice, 2) observation after optimization and standardization of hospitals drug prescription protocol, 3) evaluation of mobile phone app in pain medication follow up.
Detailed description
After informed consent, all patients operated as ambulatory surgery patients during the study period are given a letter interview for pain, pain medication and symptom follow up. They are also given a return envelope (with paid postal fee) to return the interview.
Based on the results of the first interview phase, our pain medication practice is reconsidered by anesthetists and surgeons to create a standard operating protocol for pain medication. The standard operating protocol is informed to personnel. Then, patient interview phase is repeated for another 3 months.
Then, investigators continue with a pilot study on using a mobile phone app in evaluating patients pain, sufficient pain medication and adverse effects. All patient with informed consent, suitable mobile phone, and willing to use it for reporting pain for hospital personnel are contacted via the mobile app. Other patients operated during that study period are interviewed by either letter interview or phone interview. Investigators try to estimate whether mobile apps are suitable for pain and medication follow-up.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Current practice group | – | –All plenipotentiary ambulatory surgery patients, with informed consent, during the three month study period |
| Standard operating protocol group | – | –All plenipotentiary ambulatory surgery patients, with informed consent, during the three month study period after creating and informing standardized operating protocol |
| Mobile phone app group | – | –All plenipotentiary ambulatory surgery patients during the three month study period with informed consent to use mobile phone app in assesment of pain and pain medication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients operated as ambulatory surgery patients in our clinic (orthopaedics, urology) during 3 month study periods (three 3 month phases)
Key inclusion criteria (1 listed)
- All plenipotentiary patients, operated as ambulatory surgery patients in our clinic during the study period, with informed consent
Key exclusion criteria (1 listed)
- We do not accept patients, who are not plenipotentiary (minor, incompetent, prisoners, conscript in military service) or do not understand finnish or swedish written information
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Medication
Time frame: up to two days after surgery
all pain medication used (reported By the patient)
Pain
Time frame: up to two days after surgery
Pain assessed By the patient By numerical rating scale 0-10
Adverse effects
Time frame: up to two days after surgery
Adverse effects of the pain medication, study questions
Sufficiency of pain medication
Time frame: up to two days after surgery
Whether the pain medication used was sufficient or not, study questions
Results and safety
The study was stopped early (reason given: Phase II recruitment unsuccesful, phase III lacking personnel resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
- Individual participant dataSharing planned: Undecided
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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.
Elina Reponen, MD/PhD principal investigator
Senior physician, Deputy Chief of Department
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Medication Adherence, run by Helsinki University 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 30 Jul 2020. 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.
Are results available for this study?
The study was stopped early (reason given: Phase II recruitment unsuccesful, phase III lacking personnel resources). Results are not available in the source record.
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?
Medication (time frame: up to two days after surgery). The study lists 4 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 30 Jul 2020.