Pain and Nausea After Gallbladder Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUmeå University
About this trial
The study is primarily an exploratory study of quality registry data for a swedish national cohort of patients who have undergone gallbladder surgery or ERCP, with the aim of investigating the occurrence of pain and PONV (Postoperative Nausea and Vomiting) after gallbladder surgery. Furthermore, the investigators will explorer if there are factors related to the patient or the surgical procedure that are associated with a higher risk of PONV or pain.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary gallstone surgery
Adult patients (>=18 years)
Procedure performed between 2016 and 2025
Surgical procedure registered in the national quality registry Gallriks.
Disqualifiers
If multiple surgeries on the same patient in the study database, subsequent procedures to the first procedure is excluded.
Trial population
Adult patients that had undergone gallbladder surgery in Sweden.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Postoperative nausea and vomiting
Incidence of PONV in the postoperative ward (number of surgical cases with nausea and/or vomiting) / \[total number of surgical cases\].
Time frame
Through the stay at the PACU, an average of 3.5 hours2
Postoperative Pain
Median pain score (NRS) in the postoperative ward. NRS = Numerical Rating Scale 0-10. 0 = No pain and 10 = Worst imaginable pain
Time frame
Through the stay at the PACU, an average of 3.5 hours3
Severe postoperative pain
Incidence of severe pain (NRS\>=7) \[number of surgical cases with NRS\>=7\] / \[total number of surgical cases\]. NRS = Numerical Rating Scale 0-10. 0 = No pain and 10 = Worst imaginable pain
Time frame
Through the stay at the PACU, an average of 3.5 hours4
Complications after surgery
Percentage of patients with complications, unplanned hospitalizations, or reoperations after 30 days and 6 months
Time frame
up to 6 monthSponsors and contacts
Click on the lead sponsor to view all of their trials.
Umeå University
Lead sponsor
Karolinska Institutet
Collaborator
Source ClinicalTrials.gov