The Recuperation of Patients After Elective Shoulder Surgery Observational Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Aucte Pain After Surgery; Persistent Pain After Surgery; Opioid Use After Surgery; Mode of Anaesthesia
• Intervention / Treatment: 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).

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
  • Jyväskylä, Finland
    • Central Finland Central Hospital
  • Kuopio, Finland
    • Kuopio University Hospital
  • Lahti, Finland
    • Lahti Central Hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Pori, Finland
    • Pori Central Hospital
  • Tampere, Finland, 33521
    • Tampere University Hospital
  • Tampere, Finland
    • Hatanpää Hospital
  • Tampere, Finland
    • Pihlajalinna
  • Tampere, Finland
    • Pohjola Sairaala Tampere
  • Turku, Finland
    • Turku University Hospital
  • Turku, Finland
    • NEO Hospital
  • Turku, Finland
    • Terveystalo Turku
  • Vaasa, Finland
    • Vaasa Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Type of pain relief, questionnaire	What kind of pain relief is provided for the patients after the surgery	3 months after surgery
Persistent pain after surgery, questionnaire	How are the patients doing three months after surgery -mobility, sleep, daily habits	three months after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2017
• Primary Completion (Actual): January 15, 2018
• Study Completion (Actual): January 15, 2018

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 3, 2017
• First Posted (Actual): November 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Kansanolka17

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No