Persistent Postoperative Pain After Major Emergency Abdominal Surgery

NCT04508465 | Unknown

• 1 other identifier: 2020
• Study Type: observational
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Pain Rest

  Data is collected 3 months postoperative

• Non-opiod Analgesic

  Data is collected 3 months postoperative

• Barthel-20 Index

  Data is collected 3 months postoperative

• EuroQol-5

  Data is collected 3 months postoperative

• Montreal Cognitive Assessment test (Mini-MoCA)

  Data is collected 3 months postoperative

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital, Department of Anaesthesiology

Køge, 4600, Denmark

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research coordinator RN

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 11, 2020
• Study Start: June 4, 2020
• Primary Completion: March 4, 2021
• Study Completion: June 4, 2021
• Last Updated: September 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)