NCT05050708UnknownNot Applicable
Risikofaktorer for Postoperativ Smerte og Kvalme Etter Dagkirurgisk Gynekologisk Laparoskopi
Oslo University Hospital1 site in 1 country300 target enrollmentStarted: August 24, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- postoperative pain
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective adult patients due for planned ambulatory gynaecological laparoscopy
- •Must be able to speak and write in Norwegian language
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Post-op fatigue(0-24 hrs)
- Peri-operative nausea risk score(preop, 0-24 hours post-operatively)
- Peri-operative pain risk score(preop, 0-24 hours)
- Post-op function(0-24hr)
- Post-op anti-emetic drug consumption(0-24hr)
- Post-op analgesia consumption(0-24hr)
Investigators
Johan C Ræder
professor
Oslo University Hospital
Study Sites (1)
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