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

Sponsor
Oslo University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05050708
Collaborator
(none)
300
Enrollment
1
Location
11
Anticipated Duration (Months)
27.3
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: Patient interview

Study Design

Study Type:
Observational
Anticipated Enrollment :
300 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Risikofaktorer for Postoperativ Smerte og Kvalme Etter Dagkirurgisk Gynekologisk Laparoskopi
Actual Study Start Date :
Aug 24, 2021
Anticipated Primary Completion Date :
Jun 25, 2022
Anticipated Study Completion Date :
Jul 25, 2022

Outcome Measures

Primary Outcome Measures

  1. postoperative pain [0-24 hours]

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

  2. postoperative nausea [0-24 hours]

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

Secondary Outcome Measures

  1. 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

  2. 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

  3. Post-op fatigue [0-24 hrs]

    Christensen score, 0-10, 10 is maximal fatigue

  4. Post-op function [0-24hr]

    Everyday function

  5. Post-op analgesia consumption [0-24hr]

    number of opioid equivalents consumed

  6. Post-op anti-emetic drug consumption [0-24hr]

    type and dose of ante-emetic medication

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Oslo University Hospital Oslo Norway 0424

Sponsors and Collaborators

  • Oslo University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Johan C Ræder, professor, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT05050708
Other Study ID Numbers:
  • Gyn.smerte.op.risiko.21
First Posted:
Sep 20, 2021
Last Update Posted:
Sep 20, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting

Study Results

No Results Posted as of Sep 20, 2021