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

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ClinicalTrials.gov Identifier: NCT05050708
Recruitment Status : Recruiting
First Posted : September 20, 2021
Last Update Posted : September 20, 2021
Sponsor:
Information provided by (Responsible Party):
Johan C Ræder, 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


Condition or disease Intervention/treatment
Postoperative Pain Postoperative Nausea Other: Patient interview

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Study Type : Observational
Estimated 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 : August 24, 2021
Estimated Primary Completion Date : June 25, 2022
Estimated Study Completion Date : July 25, 2022

Resource links provided by the National Library of Medicine



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


Primary Outcome Measures :
  1. postoperative pain [ Time Frame: 0-24 hours ]
    Numerical Ratings Score (NRS) Scale 0-10, 10 is worst

  2. postoperative nausea [ Time Frame: 0-24 hours ]
    yes/no, Numerical Rating Score (NRS), Scale 0-10, 10 is worst


Secondary Outcome Measures :
  1. Peri-operative nausea risk score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 0-24 hrs ]
    Christensen score, 0-10, 10 is maximal fatigue

  4. Post-op function [ Time Frame: 0-24hr ]
    Everyday function

  5. Post-op analgesia consumption [ Time Frame: 0-24hr ]
    number of opioid equivalents consumed

  6. Post-op anti-emetic drug consumption [ Time Frame: 0-24hr ]
    type and dose of ante-emetic medication



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Eligibility is based on self representation of gender identity
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult females
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05050708


Locations
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Norway
Oslo University Hospital Recruiting
Oslo, Norway, 0424
Contact: Johan Raeder, MD, PhD    004792249669    johan.rader@medisin.uio.no   
Sponsors and Collaborators
Oslo University Hospital
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Responsible Party: Johan C Ræder, professor, Oslo University Hospital
ClinicalTrials.gov Identifier: NCT05050708    
Other Study ID Numbers: Gyn.smerte.op.risiko.21
First Posted: September 20, 2021    Key Record Dates
Last Update Posted: September 20, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nausea
Postoperative Nausea and Vomiting
Postoperative Complications
Pathologic Processes
Signs and Symptoms, Digestive
Vomiting