Postoperative PainNCT05050708
Riskfactors of Post-operative Pain and Nausea After Ambulatory Gynaecological Laparocopy.
An observational study of Postoperative Pain and Postoperative Nausea, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Patient due for elective, ambulatory gynaecological laparoscopy will be screened peri-operatively for known and potential risk factors of postoperative pain and nausea/vomiting. The actual incidence and severity of pain and nausea/vomiting will be recorded during th 0-24 hr intervall after end of surgery, as well as… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain, Postoperative Nausea
- What is being tested?
- Patient interview
- How many people
- 300 participants
- Where
- 1 siteNorway
- Study dates
- 24 Aug 2021to 25 Jul 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: Adult females
Who may be able to join
- Elective adult patients due for planned ambulatory gynaecological laparoscopy
- Must be able to speak and write in Norwegian language
Who cannot join
- Patients who, for some reason, is transferred to non-ambulatory (same day discharge) care.
- Patients who, for some reason, have a change in surgical procedure from laparoscopy
Trial locations and contacts
1 site in 1 country.
Norway1 site, 1 recruiting
- Recruiting
Oslo University Hospital
Oslo, 0424
Johan Raeder, MD, PhD, 004792249669, johan.rader@medisin.uio.no
About this study
Official title: Risikofaktorer for Postoperativ Smerte og Kvalme Etter Dagkirurgisk Gynekologisk Laparoskopi
Patient due for elective, ambulatory gynaecological laparoscopy will be screened peri-operatively for known and potential risk factors of postoperative pain and nausea/vomiting.
The actual incidence and severity of pain and nausea/vomiting will be recorded during th 0-24 hr intervall after end of surgery, as well as the doses of all drugs, given for either prophylaxis or treatment
- Conditions
- Postoperative Pain, Postoperative Nausea
- Being tested
- Patient interview
- Medical subject headings
- Pain, Postoperative, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient interviewOther
Patient will be interviewed pre-operatively and at 24 hrs post-opartively
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain
Numerical Ratings Score (NRS) Scale 0-10, 10 is worst
Measured: 0-24 hours
postoperative nausea
yes/no, Numerical Rating Score (NRS), Scale 0-10, 10 is worst
Measured: 0-24 hours
Secondary outcomes (6)
Peri-operative nausea risk score
Apfel score, 0-4 (4 is maximal risk).Based on a number of registrations, such as: smoking status, postoperative opioid effects, smoking status, travel sickness, previous nause or vomiting after surgery/anaesthesia
Measured: preop, 0-24 hours post-operatively
Peri-operative pain risk score
Based on a number of registrations, such as: age, sosio-economic status, pre-op pain, pre-op use of opioids, pre-op anxiety or depression, pre-op catastrophizing, pre-op expectations, type of surgery, type of anaesthesia, lenght/ivasive ness of surgery, peri-op drug consumtion
Measured: preop, 0-24 hours
Post-op fatigue
Christensen score, 0-10, 10 is maximal fatigue
Measured: 0-24 hrs
Post-op function
Everyday function
Measured: 0-24hr
Post-op analgesia consumption
number of opioid equivalents consumed
Measured: 0-24hr
Post-op anti-emetic drug consumption
type and dose of ante-emetic medication
Measured: 0-24hr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2021
- Study start24 Aug 2021
- Primary completion25 Jun 2022 (estimated)
- Study completion25 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johan C Ræder, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05050708
- Sponsor's protocol ID
- Gyn.smerte.op.risiko.21
- Status last verified
- Sep 2021
- First submitted
- 23 Aug 2021
- Last updated
- 20 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Stjernberg M, Raeder J, Hagen M, Taraldsen Valeberg B, Comelon M. Preoperative predictive factors associated with severe postdischarge pain after ambulatory gynaecological laparoscopy: a prospective cohort study. BJA Open. 2026 Feb 27;17:100533. doi: 10.1016/j.bjao.2026.100533. eCollection 2026 Mar.
PubMed 41798320
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risikofaktorer for Postoperativ Smerte og Kvalme Etter Dagkirurgisk Gynekologisk Laparoskopi
- ClinicalTrials.gov ID
- NCT05050708
- Acronym / sponsor ID
- Gyn.smerte.op.risiko.21
- Conditions
- Postoperative Pain, Postoperative Nausea
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 24 Aug 2021 (actual)
- Primary completion
- 25 Jun 2022 (estimated)
- Study completion
- 25 Jul 2022 (estimated)
- First posted
- 20 Sep 2021 (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.
Patient due for elective, ambulatory gynaecological laparoscopy will be screened peri-operatively for known and potential risk factors of postoperative pain and nausea/vomiting.
The actual incidence and severity of pain and nausea/vomiting will be recorded during th 0-24 hr intervall after end of surgery, as well as the doses of all drugs, given for either prophylaxis or treatment
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
- Adult females
Key inclusion criteria (2 listed)
- Elective adult patients due for planned ambulatory gynaecological laparoscopy
- Must be able to speak and write in Norwegian language
Key exclusion criteria (2 listed)
- Patients who, for some reason, is transferred to non-ambulatory (same day discharge) care.
- Patients who, for some reason, have a change in surgical procedure from laparoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient interviewPatient will be interviewed pre-operatively and at 24 hrs post-opartively | Other | – |
Primary outcome
postoperative pain
Time frame: 0-24 hours
Numerical Ratings Score (NRS) Scale 0-10, 10 is worst
postoperative nausea
Time frame: 0-24 hours
yes/no, Numerical Rating Score (NRS), Scale 0-10, 10 is worst
6 secondary outcomes
Peri-operative nausea risk score
Time frame: preop, 0-24 hours post-operatively
Peri-operative pain risk score
Time frame: preop, 0-24 hours
Post-op fatigue
Time frame: 0-24 hrs
Post-op function
Time frame: 0-24hr
Post-op analgesia consumption
Time frame: 0-24hr
Post-op anti-emetic drug consumption
Time frame: 0-24hr
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2021.
- Derived from this study: PubMed 41798320Stjernberg M, Raeder J, Hagen M, Taraldsen Valeberg B, Comelon M. Preoperative predictive factors associated with severe postdischarge pain after ambulatory gynaecological laparoscopy: a prospective cohort study. BJA Open. 2026 Feb 27;17:100533. doi: 10.1016/j.bjao.2026.100533. eCollection 2026 Mar.
- Individual participant dataSharing planned: Undecided
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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.
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 Postoperative Pain and Postoperative Nausea, 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 2 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: status not confirmed, as of the sponsor's last update on 20 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative pain (time frame: 0-24 hours). 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?
On the ClinicalTrials.gov record for NCT05050708, which also lists 1 linked publication.
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 20 Sep 2021.