The Recuperation of Patients After Elective Shoulder Surgery Observational Cohort Study

NCT03335410 | Completed

• 1 other identifier: Kansanolka17
• Study Type: observational
• Target: 122
• Locations: 1 country
• Sites: 14

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.

Conditions

Aucte Pain After Surgery; Persistent Pain After Surgery; Opioid Use After Surgery; Mode of Anaesthesia

Outcome Measures

Primary Outcomes (2)

• Pain of the patient after shoulder surgery

  Acute pain

  1 week after surgery

• wellbeing of the patient after shoulder surgery

  well being after shoulder surgery

  1 week after surgery

Secondary Outcomes (3)

• type of anaesthesia, personnel questionnaire

  Day of the surgery

• Type of pain relief, questionnaire

  3 months after surgery

• Persistent pain after surgery, questionnaire

  three months after surgery

Other Outcomes (1)

• Comparison of practices by a questionnaire

  three months after surgery

Study Arms (1)

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

Interventions

Non- interventional OTHER

Non- interventional

shoulder surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (14)

Helsinki University Hospital

Helsinki, Finland

Location

Central Finland Central Hospital

Jyväskylä, Finland

Location

Kuopio University Hospital

Kuopio, Finland

Location

Lahti Central Hospital

Lahti, Finland

Location

Oulu University Hospital

Oulu, Finland

Location

Pori Central Hospital

Pori, Finland

Location

Tampere University Hospital

Tampere, 33521, Finland

Location

Hatanpää Hospital

Tampere, Finland

Location

Pihlajalinna

Tampere, Finland

Location

Pohjola Sairaala Tampere

Tampere, Finland

Location

NEO Hospital

Turku, Finland

Location

Terveystalo Turku

Turku, Finland

Location

Turku University Hospital

Turku, Finland

Location

Vaasa Central Hospital

Vaasa, Finland

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 7, 2017
• Study Start: September 15, 2017
• Primary Completion: January 15, 2018
• Study Completion: January 15, 2018
• Last Updated: September 6, 2018

Record last verified: 2018-09

Locations

FI (14)