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

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

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain; Postoperative Nausea
• Intervention / Treatment: Other: Patient interview

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Recruiting
    • Oslo University Hospital
    • Contact: Johan Raeder, MD, PhD; Phone Number: 004792249669; Email: johan.rader@medisin.uio.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Adult females

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Post-op fatigue	Christensen score, 0-10, 10 is maximal fatigue	0-24 hrs
Post-op function	Everyday function	0-24hr
Post-op analgesia consumption	number of opioid equivalents consumed	0-24hr
Post-op anti-emetic drug consumption	type and dose of ante-emetic medication	0-24hr

Collaborators and Investigators

• Sponsor: Oslo University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2021
• Primary Completion (Anticipated): June 25, 2022
• Study Completion (Anticipated): July 25, 2022

Study Registration Dates

• First Submitted: August 23, 2021
• First Submitted That Met QC Criteria: September 10, 2021
• First Posted (Actual): September 20, 2021

Study Record Updates

• Last Update Posted (Actual): September 20, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Vomiting; Nausea; Postoperative Nausea and Vomiting
• Other Study ID Numbers: Gyn.smerte.op.risiko.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No