Aucte Pain After SurgeryNCT03335410
The Recuperation of Patients After Elective Shoulder Surgery Observational Cohort Study
An observational study of Aucte Pain After Surgery and Persistent Pain After Surgery, run by Tampere University Hospital at 14 sites in Finland.
Trial summary
Around 6400 shoulder surgeries are performed yearly in Finland. The procedure is mainly day-case surgery and the patients go home in the afternoon. Shoulder surgery is one of the most common procedures performed in private surgical practices. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Aucte Pain After Surgery, Persistent Pain After Surgery, Opioid Use After Surgery
- What is being tested?
- Non- interventional
- How many people
- 122 participants
- Where
- 14 sitesFinland
- Study dates
- 15 Sep 2017to 15 Jan 2018
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Prospective cohort of patients undergoing elective shoulder surgery and capable of answering an internet-based webropol questionnaire in Finnish.
Who may be able to join
- 18-85 years
- speaks and reads Finnish fluently
- has access to internet and email
- Undergoes elective shoulder surgery
Who cannot join
- persistent pain in an area other than the shoulder in question
- longterm pain medication for any other purpose than the shoulder in question
- schitzophrenia
- diabetes mellitus with complications
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Finland14 sites
Helsinki University Hospital
Helsinki
Central Finland Central Hospital
Jyväskylä
Kuopio University Hospital
Kuopio
Lahti Central Hospital
Lahti
Oulu University Hospital
Oulu
Pori Central Hospital
Pori
Tampere University Hospital
Tampere, 33521
Hatanpää Hospital
Tampere
Pihlajalinna
Tampere
Pohjola Sairaala Tampere
Tampere
NEO Hospital
Turku
Terveystalo Turku
Turku
Turku University Hospital
Turku
Vaasa Central Hospital
Vaasa
About this study
Official title: The Recuperation of Patients After Elective Shoulder Surgery -a National Observational Cohort Study
Around 6400 shoulder surgeries are performed yearly in Finland. The procedure is mainly day-case surgery and the patients go home in the afternoon. Shoulder surgery is one of the most common procedures performed in private surgical practices. Because of the complex nature of the joint, the recovery may be complicated by severe opstoperative pain, which is relieved with strong opioids. Recently this has been addressed in the literature, as prescribed opioids too often lead to substance abuse. Pain in the acute phase after surgery is one of the common risk factors for persistent postoperative pain, which is a major burden for both the individual patient and the society.
In this prospective, observational cohort study we aim to describe current standards of practice in planning and taking care of anaeshtesia and prescribing opioids and adjuvants for postoperative pain relief at home.
Read the detailed description
Around 6400 shoulder surgeries are performed yearly in Finland. The procedure is mainly day-case surgery and the patients go home in the afternoon. Shoulder surgery is one of the most common procedures performed in private surgical practices. Because of the complex nature of the joint, the recovery may be complicated by severe opstoperative pain, which is relieved with strong opioids. Recently this has been addressed in the literature, as prescribed opioids too often lead to substance abuse. Pain in the acute phase after surgery is one of the common risk factors for persistent postoperative pain, which is a major burden for both the individual patient and the society.
In this prospective, observational cohort study we aim to describe current standards of practice in planning and taking care of anaeshtesia and prescribing opioids and adjuvants for postoperative pain relief at home.
The data is collected prospectively from the care provider and the patient in a webrobol questionnaire at three time points: the day of surgery (care provider), one week after surgery (patient) and three months after surgery (patient).
- Conditions
- Aucte Pain After Surgery, Persistent Pain After Surgery, Opioid Use After Surgery, Mode of Anaesthesia
- Being tested
- Non- interventional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non- interventionalOther
Non- interventional
| Study group | Role | What they receive |
|---|---|---|
| shoulder surgery | 18-85 years, undergoing day case shoulder surgery during 15th Sept- 15th Oct 2017, possibility to e-mail and an internet connection, understands Finnish, Receives: Other: Non- interventional |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain of the patient after shoulder surgery
Acute pain
Measured: 1 week after surgery
wellbeing of the patient after shoulder surgery
well being after shoulder surgery
Measured: 1 week after surgery
Secondary outcomes (3)
type of anaesthesia, personnel questionnaire
What is the anaesthesia, general anaesthesia, sedation or brachial plexus anaesthesia or a combination of these
Measured: Day of the surgery
Type of pain relief, questionnaire
What kind of pain relief is provided for the patients after the surgery
Measured: 3 months after surgery
Persistent pain after surgery, questionnaire
How are the patients doing three months after surgery -mobility, sleep, daily habits
Measured: three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start15 Sep 2017
- Primary completion15 Jan 2018
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aucte Pain After SurgeryStudies of the same condition, open and under way.
- More trials run by Tampere University 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tampere University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, Oulu University Hospital, Kuopio University Hospital, Helsinki University Central Hospital, Hatanpää Hospital, Tampere, Middle Finland Central Hospital, Jyväskylä, Pihlajalinna, Tampere, Terveystalo, Turku, Pori Central Hospital, Päijänne Tavastia Central Hospital, Vaasa Central Hospital, Vaasa, Finland
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335410
- Sponsor's protocol ID
- Kansanolka17
- Status last verified
- Sep 2018
- First submitted
- 30 Oct 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Recuperation of Patients After Elective Shoulder Surgery -a National Observational Cohort Study
- ClinicalTrials.gov ID
- NCT03335410
- Acronym / sponsor ID
- Kansanolka17
- Conditions
- Aucte Pain After Surgery, Persistent Pain After Surgery, Opioid Use After Surgery, Mode of Anaesthesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Tampere University HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, Oulu University Hospital, Kuopio University Hospital, Helsinki University Central Hospital, Hatanpää Hospital, Tampere, Middle Finland Central Hospital, Jyväskylä, Pihlajalinna, Tampere, Terveystalo, Turku, Pori Central Hospital, Päijänne Tavastia Central Hospital, Vaasa Central Hospital, Vaasa, Finland
- Study start
- 15 Sep 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 7 Nov 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.
Around 6400 shoulder surgeries are performed yearly in Finland. The procedure is mainly day-case surgery and the patients go home in the afternoon. Shoulder surgery is one of the most common procedures performed in private surgical practices. Because of the complex nature of the joint, the recovery may be complicated by severe opstoperative pain, which is relieved with strong opioids. Recently this has been addressed in the literature, as prescribed opioids too often lead to substance abuse. Pain in the acute phase after surgery is one of the common risk factors for persistent postoperative pain, which is a major burden for both the individual patient and the society.
In this prospective, observational cohort study we aim to describe current standards of practice in planning and taking care of anaeshtesia and prescribing opioids and adjuvants for postoperative pain relief at home.
Detailed description
Around 6400 shoulder surgeries are performed yearly in Finland. The procedure is mainly day-case surgery and the patients go home in the afternoon. Shoulder surgery is one of the most common procedures performed in private surgical practices. Because of the complex nature of the joint, the recovery may be complicated by severe opstoperative pain, which is relieved with strong opioids. Recently this has been addressed in the literature, as prescribed opioids too often lead to substance abuse. Pain in the acute phase after surgery is one of the common risk factors for persistent postoperative pain, which is a major burden for both the individual patient and the society.
In this prospective, observational cohort study we aim to describe current standards of practice in planning and taking care of anaeshtesia and prescribing opioids and adjuvants for postoperative pain relief at home.
The data is collected prospectively from the care provider and the patient in a webrobol questionnaire at three time points: the day of surgery (care provider), one week after surgery (patient) and three months after surgery (patient).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| shoulder surgery | – | Other: Non- interventional18-85 years, undergoing day case shoulder surgery during 15th Sept- 15th Oct 2017, possibility to e-mail and an internet connection, understands Finnish, |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Prospective cohort of patients undergoing elective shoulder surgery and capable of answering an internet-based webropol questionnaire in Finnish.
Key inclusion criteria (4 listed)
- 18-85 years
- speaks and reads Finnish fluently
- has access to internet and email
- Undergoes elective shoulder surgery
Key exclusion criteria (4 listed)
- persistent pain in an area other than the shoulder in question
- longterm pain medication for any other purpose than the shoulder in question
- schitzophrenia
- diabetes mellitus with complications
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 |
|---|---|---|
| Non- interventionalNon- interventional | Other | shoulder surgery |
Primary outcome
Pain of the patient after shoulder surgery
Time frame: 1 week after surgery
Acute pain
wellbeing of the patient after shoulder surgery
Time frame: 1 week after surgery
well being after shoulder surgery
3 secondary outcomes
type of anaesthesia, personnel questionnaire
Time frame: Day of the surgery
Type of pain relief, questionnaire
Time frame: 3 months after surgery
Persistent pain after surgery, questionnaire
Time frame: three months after surgery
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 6 Sep 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Aucte Pain After Surgery and Persistent Pain After Surgery, run by Tampere University Hospital at 14 sites 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 4 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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites 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 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 of the patient after shoulder surgery (time frame: 1 week after surgery). 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 6 Sep 2018.