Persistent Postoperative Pain After Major Emergency Abdominal Surgery

• Conditions: Chronic Postoperative Pain

• Registration Number: NCT04508465
• Lead Sponsor: Zealand University Hospital

Brief Summary

Perioperative pain is one of the most significant complaints and problems for patients undergoing major open surgery. Pain after surgery carry an abundance of consequences such as reduced mobilization, reduced nutrition intake, reduced pulmonary capacity and increased risk of complications and length of hospitalization. The literature does not supply much information on short- or longer-term outcomes of pain treatment for emergency surgery. The investigators know that for planned surgery in general around 10-50 percentage suffer from persistent postoperative pain. It is therefore important to follow-up on the longer-term outcomes after the standardized analgesic pain treatment. Based on a predefined patient group called OMEGA (Optimizing Major EMergency Abdominal surgery) the investigators hypothesize that OMEGA patients will present a significant incidence rate of patients with persistent postoperative pain and/or continued opioid/non-opioid usage. Therefore this study is to investigate the incidence of prolonged postoperative pain and opioid/non-opioid consumption in OMEGA patients at 3 month after major emergency abdominal surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-04
• Study First Submitted: 2020-07-30
• Study First Submitted QC: 2020-08-07
• Study First Posted: 2020-08-11
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-09
• Primary Completion: 2021-03-04
• Study Completion: 2021-06-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 110

Inclusion Criteria

• OMEGA patients (patients who have undergone major emergency abdominal surgery including the stomach, small or large bowel, or rectum for conditions such as perforation, ischemia, abdominal abscess, bleeding or obstruction)
• Age 18 or more
• Surgery performed within 72 hours of an acute admission or as an acute re-operation

Exclusion Criteria

• Elective laparoscopy
• Diagnostic laparotomy/laparoscopy where no subsequent procedure is performed
• Non-elective hernia repair without bowel resection
• Admission or transfer to an intensive care unit

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pain Mobilization	Data is collected 3 months postoperative	Pain during mobilization last week based on a self-made questionary
Opioids	Data is collected 3 months postoperative	Daily opioid usage last week based on a self-made questionary

Secondary Outcome Measures

Name	Time	Method
Pain Rest	Data is collected 3 months postoperative	Pain in rest last week based on a self-made questionary
Non-opiod Analgesic	Data is collected 3 months postoperative	Non-opioid analgesic usage based on a self-made questionary
EuroQol-5	Data is collected 3 months postoperative	Health related quality of life
Barthel-20 Index	Data is collected 3 months postoperative	Simple function measurement based on daily living; Simple function measurement
Montreal Cognitive Assessment test (Mini-MoCA)	Data is collected 3 months postoperative	Cognitive function

Trial Locations

Locations (1)

Zealand University Hospital, Department of Anaesthesiology; 🇩🇰 Køge, Denmark