Persistent Postoperative Pain After Major Emergency Abdominal Surgery

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Postoperative Pain

• Study Type: Observational
• Enrollment (Anticipated): 110

Contacts and Locations

Study Locations

• Denmark
  • Køge, Denmark, 4600
    • Zealand University Hospital, Department of Anaesthesiology

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone major emergency abdominal surgery at the department of abdominal surgery at Zealand University Hospital Køge

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
OMEGA; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zealand University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 4, 2020
• Primary Completion (ANTICIPATED): March 4, 2021
• Study Completion (ANTICIPATED): June 4, 2021

Study Registration Dates

• First Submitted: July 30, 2020
• First Submitted That Met QC Criteria: August 7, 2020
• First Posted (ACTUAL): August 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 9, 2020
• Last Update Submitted That Met QC Criteria: September 8, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Disease Attributes; Pain, Postoperative; Emergencies
• Other Study ID Numbers: 2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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