Riskfactors of Post-operative Pain and Nausea After Ambulatory Gynaecological Laparocopy.

• Conditions: Postoperative Pain; Postoperative Nausea

• Registration Number: NCT05050708
• Lead Sponsor: Oslo University Hospital

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-23
• Study Start: 2021-08-24
• Status Verified: 2021-09
• Study First Submitted QC: 2021-09-10
• Last Update Submitted: 2021-09-10
• Study First Posted: 2021-09-20
• Last Update Posted: 2021-09-20
• Primary Completion: 2022-06-25
• Study Completion: 2022-07-25

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
postoperative pain	0-24 hours	Numerical Ratings Score (NRS) Scale 0-10, 10 is worst
postoperative nausea	0-24 hours	yes/no, Numerical Rating Score (NRS), Scale 0-10, 10 is worst

Secondary Outcome Measures

Name	Time	Method
Peri-operative nausea risk score	preop, 0-24 hours post-operatively	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
Peri-operative pain risk score	preop, 0-24 hours	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
Post-op function	0-24hr	Everyday function
Post-op anti-emetic drug consumption	0-24hr	type and dose of ante-emetic medication
Post-op analgesia consumption	0-24hr	number of opioid equivalents consumed
Post-op fatigue	0-24 hrs	Christensen score, 0-10, 10 is maximal fatigue

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway