PainPOP-MatrixNCT07308444
Predicting Pain After Ambulatory Gynaecological Laparoscopies
An observational study of Pain, run by Oslo University Hospital at 1 site in Norway.
Trial summary
As day surgery is increasingly preferred over in-hospital treatment due to feasibility and reduced economic costs, it is important to evaluate patient-related outcomes such as comfort and safety after discharge. Most previous studies on predictors for postoperative pain have not focused on postdischarge pain. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain
- How many people
- 487 participants
- Where
- 1 siteNorway
- Study dates
- 19 Aug 2021to 30 Jun 2022
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women scheduled for ambulatory gynaecological laparoscopic procedures such as: ovarian cyst removal, excision of endometriosis, salpingo-oophorectomy, salpingectomy, chromopertubation, ovarian drilling for polycystic ovary syndrome, adhesion removal, diagnostic laparoscopy, oophorectomy, removal of migrated intrauterine device, sterilisation/tubal ligation.
Who may be able to join
- Participant must be 18 years of age at the time of signing the informed consent.
- Participant scheduled for ambulatory gynaecological laparoscopy.
- Capable of giving written informed consent.
- Must speak and read Norwegian.
Who cannot join
- Severe psychiatric disorder, severe cognitive dysfunction.
- Intraoperative ketamine or lidocaine infusion or regional anaesthesia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Risk Matrix for Severe Postdischarge Pain After Ambulatory Gynaecological Laparoscopy
As day surgery is increasingly preferred over in-hospital treatment due to feasibility and reduced economic costs, it is important to evaluate patient-related outcomes such as comfort and safety after discharge. Most previous studies on predictors for postoperative pain have not focused on postdischarge pain. In a previous study, we found that over 42% of the patients experienced severe postdischarge pain within the first 24 h after ambulatory gynaecologocal laparoscopic surgery, that is a pain score of 7-10 on the NRS. We identified four preoperative risk factors independently associated with severe postdischarge pain. We have developed a risk matrix to predict who will suffer from severe pain after surgery. The risk matrix needs to be validated in a new gynaecological patient sample. It has the potential to improve clinical practice by providing clinicians with a simple, evidence-based tool that can identify high-risk patients before surgery. The scoring takes less than one minute. Today, we do not have such an instrument at hand. The results from this project could influence current routines and treatments at Oslo University Hospital and may also apply to other patient populations and other hospitals.
The primary research objective is to validate a previously developed risk matrix for postdischarge pain in gynecological day-surgery patients.
Read the detailed description
Early identification of patients at high risk for severe pain can contribute to better and more targeted individual pain prevention and management, thereby reducing the incidence of unnecessary pain and discomfort after surgery. By identifying and treating patients who are particularly vulnerable to severe postoperative pain, we can also reduce the length of hospital stays, prevent unplanned admissions due to pain, decrease the number of outpatient inquiries related to pain, and expedite recovery and return to normal activities. This will contribute to reduced resource use, improved patient care, and hopefully increased patient satisfaction.
In this prospective observational cohort study, we will collect post-discharge pain data necessary to validate a previously developed risk matrix at two different time points: T1) preoperatively on the day of surgery, and T2) during a follow-up call on POD1. In addition, patients' postoperative pain will be assessed using the NRS during PACU stay.
According to the sample size calculation (n=188) + at least 10%, we will include at least 207 patients.
There is no risk connected to participation in the study. All patients will receive standard medical and surgical treatment throughout the study.
- Conditions
- Pain
- Keywords
- Risk matrix
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
Severe postdischarge pain
Numerical rating scale for pain, severe pain defined as 7-10 on scale.
Measured: Time from hospital discharge until 24 hours after end of surgery.
Secondary outcomes (4)
Preoperative use of opioids
Measured: Last four weeks prior to surgery
Age
Measured: Age in years at time for surgery
Preoperative pain
Patient NRS (0-10) level before surgery
Measured: At time for surgery
Pain expectation
Expected postoperative pain intensity (NRS 0-10)
Measured: After surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start19 Aug 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- 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
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlin Comelon, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07308444
- Sponsor's protocol ID
- 939735
- Acronym
- POP-Matrix
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2025
- Last updated
- 21 Apr 2026
- 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 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Risk Matrix for Severe Postdischarge Pain After Ambulatory Gynaecological Laparoscopy
- ClinicalTrials.gov ID
- NCT07308444
- Acronym / sponsor ID
- POP-Matrix / 939735
- Conditions
- Pain
- Keywords
- Risk matrix
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 29 Dec 2025 (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.
As day surgery is increasingly preferred over in-hospital treatment due to feasibility and reduced economic costs, it is important to evaluate patient-related outcomes such as comfort and safety after discharge. Most previous studies on predictors for postoperative pain have not focused on postdischarge pain. In a previous study, we found that over 42% of the patients experienced severe postdischarge pain within the first 24 h after ambulatory gynaecologocal laparoscopic surgery, that is a pain score of 7-10 on the NRS. We identified four preoperative risk factors independently associated with severe postdischarge pain. We have developed a risk matrix to predict who will suffer from severe pain after surgery. The risk matrix needs to be validated in a new gynaecological patient sample. It has the potential to improve clinical practice by providing clinicians with a simple, evidence-based tool that can identify high-risk patients before surgery. The scoring takes less than one minute. Today, we do not have such an instrument at hand. The results from this project could influence current routines and treatments at Oslo University Hospital and may also apply to other patient populations and other hospitals.
The primary research objective is to validate a previously developed risk matrix for postdischarge pain in gynecological day-surgery patients.
Detailed description
Early identification of patients at high risk for severe pain can contribute to better and more targeted individual pain prevention and management, thereby reducing the incidence of unnecessary pain and discomfort after surgery. By identifying and treating patients who are particularly vulnerable to severe postoperative pain, we can also reduce the length of hospital stays, prevent unplanned admissions due to pain, decrease the number of outpatient inquiries related to pain, and expedite recovery and return to normal activities. This will contribute to reduced resource use, improved patient care, and hopefully increased patient satisfaction.
In this prospective observational cohort study, we will collect post-discharge pain data necessary to validate a previously developed risk matrix at two different time points: T1) preoperatively on the day of surgery, and T2) during a follow-up call on POD1. In addition, patients' postoperative pain will be assessed using the NRS during PACU stay.
According to the sample size calculation (n=188) + at least 10%, we will include at least 207 patients.
There is no risk connected to participation in the study. All patients will receive standard medical and surgical treatment throughout the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women scheduled for ambulatory gynaecological laparoscopic procedures such as: ovarian cyst removal, excision of endometriosis, salpingo-oophorectomy, salpingectomy, chromopertubation, ovarian drilling for polycystic ovary syndrome, adhesion removal, diagnostic laparoscopy, oophorectomy, removal of migrated intrauterine device, sterilisation/tubal ligation.
Key inclusion criteria (4 listed)
- Participant must be 18 years of age at the time of signing the informed consent.
- Participant scheduled for ambulatory gynaecological laparoscopy.
- Capable of giving written informed consent.
- Must speak and read Norwegian.
Key exclusion criteria (2 listed)
- Severe psychiatric disorder, severe cognitive dysfunction.
- Intraoperative ketamine or lidocaine infusion or regional anaesthesia.
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
Severe postdischarge pain
Time frame: Time from hospital discharge until 24 hours after end of surgery.
Numerical rating scale for pain, severe pain defined as 7-10 on scale.
4 secondary outcomes
Preoperative use of opioids
Time frame: Last four weeks prior to surgery
Age
Time frame: Age in years at time for surgery
Preoperative pain
Time frame: At time for surgery
Pain expectation
Time frame: After surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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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 Pain, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 2 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: finished, as of the sponsor's last update on 21 Apr 2026. 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 Norway. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Severe postdischarge pain (time frame: Time from hospital discharge until 24 hours after end of surgery.). 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 21 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.