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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03335410
Other study ID # Kansanolka17
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 15, 2017
Est. completion date January 15, 2018

Study information

Verified date September 2018
Source Tampere University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date January 15, 2018
Est. primary completion date January 15, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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

Study Design


Intervention

Other:
Non- interventional
Non- interventional

Locations

Country Name City State
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 Hatanpää Hospital Tampere
Finland Pihlajalinna Tampere
Finland Pohjola Sairaala Tampere Tampere
Finland Tampere University Hospital Tampere
Finland NEO Hospital Turku
Finland Terveystalo Turku Turku
Finland Turku University Hospital Turku
Finland Vaasa Central Hospital Vaasa

Sponsors (12)

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

Country where clinical trial is conducted

Finland, 

Outcome

Type Measure Description Time frame Safety issue
Other Comparison of practices by a questionnaire Compare the patient outcome results by a questionnaire based on the mode of anaesthesia/center three months after surgery
Primary Pain of the patient after shoulder surgery Acute pain 1 week after surgery
Primary wellbeing of the patient after shoulder surgery well being after shoulder surgery 1 week after surgery
Secondary type of anaesthesia, personnel questionnaire What is the anaesthesia, general anaesthesia, sedation or brachial plexus anaesthesia or a combination of these Day of the surgery
Secondary Type of pain relief, questionnaire What kind of pain relief is provided for the patients after the surgery 3 months after surgery
Secondary Persistent pain after surgery, questionnaire How are the patients doing three months after surgery -mobility, sleep, daily habits three months after surgery