Persistent Postoperative Pain After Major Emergency Abdominal Surgery

Chronic Postoperative Pain Clinical Trial

Official title:

Persistent Postoperative Pain After Major Emergency Abdominal Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04508465
• Other study ID #: 2020
• Status: Enrolling by invitation
• Start date: June 4, 2020
• Est. completion date: June 4, 2021

Study information

• Verified date: September 2020
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 110
• Est. completion date: June 4, 2021
• Est. primary completion date: March 4, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Postoperative Pain
• Emergencies
• Pain, Postoperative

Locations

Country	Name	City	State
Denmark	Zealand University Hospital, Department of Anaesthesiology	Køge

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Mobilization	Pain during mobilization last week based on a self-made questionary	Data is collected 3 months postoperative
Primary	Opioids	Daily opioid usage last week based on a self-made questionary	Data is collected 3 months postoperative
Secondary	Pain Rest	Pain in rest last week based on a self-made questionary	Data is collected 3 months postoperative
Secondary	Non-opiod Analgesic	Non-opioid analgesic usage based on a self-made questionary	Data is collected 3 months postoperative
Secondary	Barthel-20 Index	Simple function measurement based on daily living; Simple function measurement	Data is collected 3 months postoperative
Secondary	EuroQol-5	Health related quality of life	Data is collected 3 months postoperative
Secondary	Montreal Cognitive Assessment test (Mini-MoCA)	Cognitive function	Data is collected 3 months postoperative