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NCT Number: NCT03335410

The Recuperation of Patients After Elective Shoulder Surgery 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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Helsinki University Hospital, Helsinki, Finland

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About this 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.

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non- interventional

Other

Non- interventional

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

  • Hatanpää Hospital, Tampere
  • Helsinki University Central Hospital
  • Kuopio University Hospital
  • Middle Finland Central Hospital, Jyväskylä
  • Oulu University Hospital
  • Pihlajalinna, Tampere
  • Päijänne Tavastia Central Hospital
  • Satakunta Central Hospital, Pori
  • Terveystalo, Turku
  • Turku University Hospital
  • Vaasa Central Hospital, Vaasa, Finland

Registry information

Official study title

The Recuperation of Patients After Elective Shoulder Surgery -a National Observational Cohort Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 7, 2017
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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