Predicting Pain After Ambulatory Gynaecological Laparoscopies

NCT07308444 | Completed

• 1 other identifier: 939735
• Study Type: observational
• Target: 487
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pain

Keywords

Risk matrix

Outcome Measures

Primary Outcomes (1)

• Severe postdischarge pain

  Numerical rating scale for pain, severe pain defined as 7-10 on scale.

  Time from hospital discharge until 24 hours after end of surgery.

Secondary Outcomes (4)

• Preoperative use of opioids

  Last four weeks prior to surgery

• Age

  Age in years at time for surgery

• Preoperative pain

  At time for surgery

• Pain expectation

  After surgery

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women by biological sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Oslo University Hospital: lead

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Physician, Anesthesiologist, PhD

Study Record Dates

• First Submitted: December 5, 2025
• First Posted: December 29, 2025
• Study Start: August 19, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)