The Recuperation of Patients After Elective Shoulder Surgery Observational Cohort Study

Completed

• Conditions: Mode of Anaesthesia; Aucte Pain After Surgery; Persistent Pain After Surgery; Opioid Use After Surgery
• Interventions: Other: Non- interventional

• Registration Number: NCT03335410
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-09-15
• Study First Submitted: 2017-10-30
• Study First Submitted QC: 2017-11-03
• Study First Posted: 2017-11-07
• Primary Completion: 2018-01-15
• Study Completion: 2018-01-15
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 122

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
shoulder surgery	Non- interventional	18-85 years, undergoing day case shoulder surgery during 15th Sept- 15th Oct 2017, possibility to e-mail and an internet connection, understands Finnish,

Primary Outcome Measures

Name	Time	Method
Pain of the patient after shoulder surgery	1 week after surgery	Acute pain
wellbeing of the patient after shoulder surgery	1 week after surgery	well being after shoulder surgery

Secondary Outcome Measures

Name	Time	Method
Type of pain relief, questionnaire	3 months after surgery	What kind of pain relief is provided for the patients after the surgery
Persistent pain after surgery, questionnaire	three months after surgery	How are the patients doing three months after surgery -mobility, sleep, daily habits
type of anaesthesia, personnel questionnaire	Day of the surgery	What is the anaesthesia, general anaesthesia, sedation or brachial plexus anaesthesia or a combination of these

Trial Locations

Locations (14)

Helsinki University Hospital; 🇫🇮 Helsinki, Finland

Central Finland Central Hospital; 🇫🇮 Jyväskylä, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Pori Central Hospital; 🇫🇮 Pori, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland

Pohjola Sairaala Tampere; 🇫🇮 Tampere, Finland

NEO Hospital; 🇫🇮 Turku, Finland

Terveystalo Turku; 🇫🇮 Turku, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Lahti Central Hospital; 🇫🇮 Lahti, Finland

Hatanpää Hospital; 🇫🇮 Tampere, Finland

Vaasa Central Hospital; 🇫🇮 Vaasa, Finland

Pihlajalinna; 🇫🇮 Tampere, Finland