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Completed

NCT Number: NCT07308444

Predicting Pain After Ambulatory Gynaecological Laparoscopies

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Oslo University Hospital

Oslo, 0424, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Severe psychiatric disorder, severe cognitive dysfunction.
  • Intraoperative ketamine or lidocaine infusion or regional anaesthesia.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Preoperative use of opioids

    Time frame: Last four weeks prior to surgery

  2. Age

    Time frame: Age in years at time for surgery

  3. Preoperative pain

    Time frame: At time for surgery

    Patient NRS (0-10) level before surgery

  4. Pain expectation

    Time frame: After surgery

    Expected postoperative pain intensity (NRS 0-10)

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

Validation of a Risk Matrix for Severe Postdischarge Pain After Ambulatory Gynaecological Laparoscopy

Acronym: POP-Matrix

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 29, 2025
Registry last updated
Apr 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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