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

Postoperative Pain Clinical Trial

Official title:

Risikofaktorer for Postoperativ Smerte og Kvalme Etter Dagkirurgisk Gynekologisk Laparoskopi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05050708
• Other study ID #: Gyn.smerte.op.risiko.21
• Status: Recruiting
• Start date: August 24, 2021
• Est. completion date: July 25, 2022

Study information

• Verified date: September 2021
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: July 25, 2022
• Est. primary completion date: June 25, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea
• Postoperative Nausea and Vomiting
• Postoperative Pain

Intervention

Other:
• Patient interview
Patient will be interviewed pre-operatively and at 24 hrs post-opartively

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain	Numerical Ratings Score (NRS) Scale 0-10, 10 is worst	0-24 hours
Primary	postoperative nausea	yes/no, Numerical Rating Score (NRS), Scale 0-10, 10 is worst	0-24 hours
Secondary	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	preop, 0-24 hours post-operatively
Secondary	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	preop, 0-24 hours
Secondary	Post-op fatigue	Christensen score, 0-10, 10 is maximal fatigue	0-24 hrs
Secondary	Post-op function	Everyday function	0-24hr
Secondary	Post-op analgesia consumption	number of opioid equivalents consumed	0-24hr
Secondary	Post-op anti-emetic drug consumption	type and dose of ante-emetic medication	0-24hr