NCT05050708

Brief 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 the doses of all drugs, given for either prophylaxis or treatment

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

August 24, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

September 20, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
Last Updated

September 20, 2021

Status Verified

September 1, 2021

Enrollment Period

10 months

First QC Date

August 23, 2021

Last Update Submit

September 10, 2021

Conditions

Postoperative PainPostoperative Nausea

Outcome Measures

Primary Outcomes (2)

  • postoperative pain

    Numerical Ratings Score (NRS) Scale 0-10, 10 is worst

    0-24 hours

  • postoperative nausea

    yes/no, Numerical Rating Score (NRS), Scale 0-10, 10 is worst

    0-24 hours

Secondary Outcomes (6)

  • Peri-operative nausea risk score

    preop, 0-24 hours post-operatively

  • Peri-operative pain risk score

    preop, 0-24 hours

  • Post-op fatigue

    0-24 hrs

  • Post-op function

    0-24hr

  • Post-op analgesia consumption

    0-24hr

  • +1 more secondary outcomes

Interventions

Patient interviewOTHER

Patient will be interviewed pre-operatively and at 24 hrs post-opartively

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsEligibility is based on self representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult females

You may qualify if:

  • Elective adult patients due for planned ambulatory gynaecological laparoscopy
  • Must be able to speak and write in Norwegian language

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativePostoperative Nausea and Vomiting

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsNauseaSigns and Symptoms, DigestiveVomiting

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 23, 2021

First Posted

September 20, 2021

Study Start

August 24, 2021

Primary Completion

June 25, 2022

Study Completion

July 25, 2022

Last Updated

September 20, 2021

Record last verified: 2021-09

Locations

NO(1)