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Clinical Trials/NCT04508465
NCT04508465
Unknown
Not Applicable

Persistent Postoperative Pain After Major Emergency Abdominal Surgery

Zealand University Hospital1 site in 1 country110 target enrollmentJune 4, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Chronic Postoperative Pain
Sponsor
Zealand University Hospital
Enrollment
110
Locations
1
Primary Endpoint
Pain Mobilization
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 4, 2020
End Date
June 4, 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cecilie Bauer Derby

Research coordinator RN

Zealand University Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pain Mobilization

Time Frame: Data is collected 3 months postoperative

Pain during mobilization last week based on a self-made questionary

Opioids

Time Frame: Data is collected 3 months postoperative

Daily opioid usage last week based on a self-made questionary

Secondary Outcomes

  • Pain Rest(Data is collected 3 months postoperative)
  • Non-opiod Analgesic(Data is collected 3 months postoperative)
  • EuroQol-5(Data is collected 3 months postoperative)
  • Barthel-20 Index(Data is collected 3 months postoperative)
  • Montreal Cognitive Assessment test (Mini-MoCA)(Data is collected 3 months postoperative)

Study Sites (1)

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