Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Recuperation of Patients After Elective Shoulder Surgery Observational Cohort Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03335410
Recruitment Status : Completed
First Posted : November 7, 2017
Last Update Posted : September 6, 2018
Sponsor:
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
Satakunta Central Hospital, Pori
Päijänne Tavastia Central Hospital
Vaasa Central Hospital, Vaasa, Finland
Information provided by (Responsible Party):
Tampere University Hospital

Brief 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. 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.


Condition or disease Intervention/treatment
Aucte Pain After Surgery Persistent Pain After Surgery Opioid Use After Surgery Mode of Anaesthesia Other: Non- interventional

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).

Layout table for study information
Study Type : Observational
Actual Enrollment : 122 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Recuperation of Patients After Elective Shoulder Surgery -a National Observational Cohort Study
Actual Study Start Date : September 15, 2017
Actual Primary Completion Date : January 15, 2018
Actual Study Completion Date : January 15, 2018

Group/Cohort Intervention/treatment
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,
Other: Non- interventional
Non- interventional




Primary Outcome Measures :
  1. Pain of the patient after shoulder surgery [ Time Frame: 1 week after surgery ]
    Acute pain

  2. wellbeing of the patient after shoulder surgery [ Time Frame: 1 week after surgery ]
    well being after shoulder surgery


Secondary Outcome Measures :
  1. type of anaesthesia, personnel questionnaire [ Time Frame: Day of the surgery ]
    What is the anaesthesia, general anaesthesia, sedation or brachial plexus anaesthesia or a combination of these

  2. Type of pain relief, questionnaire [ Time Frame: 3 months after surgery ]
    What kind of pain relief is provided for the patients after the surgery

  3. Persistent pain after surgery, questionnaire [ Time Frame: three months after surgery ]
    How are the patients doing three months after surgery -mobility, sleep, daily habits


Other Outcome Measures:
  1. Comparison of practices by a questionnaire [ Time Frame: three months after surgery ]
    Compare the patient outcome results by a questionnaire based on the mode of anaesthesia/center



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Prospective cohort of patients undergoing elective shoulder surgery and capable of answering an internet-based webropol questionnaire in Finnish.
Criteria

Inclusion Criteria:

  • 18-85 years
  • speaks and reads Finnish fluently
  • has access to internet and email
  • Undergoes elective shoulder surgery

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03335410


Locations
Layout table for location information
Finland
Helsinki University Hospital
Helsinki, Finland
Central Finland Central Hospital
Jyväskylä, Finland
Kuopio University Hospital
Kuopio, Finland
Lahti Central Hospital
Lahti, Finland
Oulu University Hospital
Oulu, Finland
Pori Central Hospital
Pori, Finland
Tampere University Hospital
Tampere, Finland, 33521
Hatanpää Hospital
Tampere, Finland
Pihlajalinna
Tampere, Finland
Pohjola Sairaala Tampere
Tampere, Finland
NEO Hospital
Turku, Finland
Terveystalo Turku
Turku, Finland
Turku University Hospital
Turku, Finland
Vaasa Central Hospital
Vaasa, Finland
Sponsors and Collaborators
Tampere University Hospital
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
Satakunta Central Hospital, Pori
Päijänne Tavastia Central Hospital
Vaasa Central Hospital, Vaasa, Finland
Layout table for additonal information
Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03335410    
Other Study ID Numbers: Kansanolka17
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No