Persistent Postoperative Pain After Major Emergency Abdominal Surgery

Sponsor
Zealand University Hospital (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04508465
Collaborator
(none)
110
1
12
9.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    110 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Persistent Postoperative Pain After Major Emergency Abdominal Surgery
    Actual Study Start Date :
    Jun 4, 2020
    Anticipated Primary Completion Date :
    Mar 4, 2021
    Anticipated Study Completion Date :
    Jun 4, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Pain Mobilization [Data is collected 3 months postoperative]

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

    2. Opioids [Data is collected 3 months postoperative]

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

    Secondary Outcome Measures

    1. Pain Rest [Data is collected 3 months postoperative]

      Pain in rest last week based on a self-made questionary

    2. Non-opiod Analgesic [Data is collected 3 months postoperative]

      Non-opioid analgesic usage based on a self-made questionary

    3. Barthel-20 Index [Data is collected 3 months postoperative]

      Simple function measurement based on daily living Simple function measurement

    4. EuroQol-5 [Data is collected 3 months postoperative]

      Health related quality of life

    5. Montreal Cognitive Assessment test (Mini-MoCA) [Data is collected 3 months postoperative]

      Cognitive function

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zealand University Hospital, Department of Anaesthesiology Køge Denmark 4600

    Sponsors and Collaborators

    • Zealand University Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Cecilie Bauer Derby, Research coordinator RN, Zealand University Hospital
    ClinicalTrials.gov Identifier:
    NCT04508465
    Other Study ID Numbers:
    • 2020
    First Posted:
    Aug 11, 2020
    Last Update Posted:
    Sep 9, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 9, 2020