Chronic Postoperative PainNCT04508465
Persistent Postoperative Pain After Major Emergency Abdominal Surgery
An observational study of Chronic Postoperative Pain, run by Zealand University Hospital at 1 site in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Postoperative Pain
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Jun 2020to 4 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone major emergency abdominal surgery at the department of abdominal surgery at Zealand University Hospital Køge
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Zealand University Hospital, Department of Anaesthesiology
Køge, 4600
About this study
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
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Pain Mobilization
Pain during mobilization last week based on a self-made questionary
Measured: Data is collected 3 months postoperative
Opioids
Daily opioid usage last week based on a self-made questionary
Measured: Data is collected 3 months postoperative
Secondary outcomes (5)
Pain Rest
Pain in rest last week based on a self-made questionary
Measured: Data is collected 3 months postoperative
Non-opiod Analgesic
Non-opioid analgesic usage based on a self-made questionary
Measured: Data is collected 3 months postoperative
Barthel-20 Index
Simple function measurement based on daily living
Simple function measurement
Measured: Data is collected 3 months postoperative
EuroQol-5
Health related quality of life
Measured: Data is collected 3 months postoperative
Montreal Cognitive Assessment test (Mini-MoCA)
Cognitive function
Measured: Data is collected 3 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start4 Jun 2020
- Primary completion4 Mar 2021 (estimated)
- Study completion4 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cecilie Bauer Derby, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04508465
- Sponsor's protocol ID
- 2020
- Status last verified
- Sep 2020
- First submitted
- 30 Jul 2020
- Last updated
- 9 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistent Postoperative Pain After Major Emergency Abdominal Surgery
- ClinicalTrials.gov ID
- NCT04508465
- Acronym / sponsor ID
- 2020
- Conditions
- Chronic Postoperative Pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 4 Mar 2021 (estimated)
- Study completion
- 4 Jun 2021 (estimated)
- First posted
- 11 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone major emergency abdominal surgery at the department of abdominal surgery at Zealand University Hospital Køge
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
5 secondary outcomes
Pain Rest
Time frame: Data is collected 3 months postoperative
Non-opiod Analgesic
Time frame: Data is collected 3 months postoperative
Barthel-20 Index
Time frame: Data is collected 3 months postoperative
EuroQol-5
Time frame: Data is collected 3 months postoperative
Montreal Cognitive Assessment test (Mini-MoCA)
Time frame: Data is collected 3 months postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
- Individual participant dataSharing planned: No
Related trials for Chronic Postoperative Pain
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Recruiting
Uncovering the Mechanism of Pain Relief by Peripheral Transcutaneous Magnetic Stimulation
Post-Surgical Pain, Chronic, Post-traumatic Pain, Chronic
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Postoperative Pain, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Mobilization (time frame: Data is collected 3 months postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2020.