Analgesia, Anesthesia, Surgical Procedure, Operative
Conditions
Keywords
anesthesia recovery period, postoperative complications, pain, pain measurement, postoperative nausea and vomiting, quality of life, genetic association study
Brief summary
Prospective association study to analyse perioperative patients' outcome. Outcome comprises intraoperative and postoperative complications e.g. cardio-vascular events, allergic reactions, Possible variables which might have on influence: patient- and surgery-related data, patients' genetic background etc.
Detailed description
Background Anesthesia and surgery are related to unwanted adverse events, side effects and postoperative discomfort. Whereas severe complications like cardiovascular events are rare, postoperative side effects like nausea and vomiting, pain, long-lasting pain and pain related interference of daily activities are frequent. The question arises which patient is at specific risk for this sequelae. Pre-exiting predisposing factors (e.g. patients' genetic background), surgery and anesthesia related variables (drugs, techniques administered for anesthesia and analgesia) as well as psychological and social factors might influence the outcome. In this prospective association study these variables will be investigated in a well-described patient cohort presenting for elective surgery. Objective The aim of this study is to associate perioperative and postoperative complications and side effects as well as long-term outcome after surgery to patient- and surgery-related variables, including genetic variants. Methods Prospective association study performed in two independent patient cohorts.
Interventions
None listed
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years and older * Written informed consent * Scheduled surgery
Exclusion criteria
* No informed consent * Cognitive impairment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative nausea and vomiting (PONV) | Up to 48 hours after surgery | Percent of patients with no PONV, medium PONV and severe PONV PONV outcome measured by a composite score: number of episodes of vomiting + severity of nausea (NRS score) + need for antiemetic treatment Patients with no PONV are compared to those with intermediate and severe PONV |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain related impairment after surgery | up to 2 days after surgery | Measured by the International Pain Outcomes Questionnaire |
| Pain related impairment of patients with chronic pain after surgery versus patients without chronic pain after surgery | up to one year after surgery | Measured by the Brief Pain Inventory (BPI) |
| Cardio-vascular events after surgery | Up to 30 days after surgery | Measured by a score for major adverse cardiac events (MACE) |
| Pain related impairment of patients with chronic neuropathic pain (DN4 positive) after surgery versus patients without neuropathic pain after surgery | up to one year after surgery | Measured by the Brief Pain Inventory (BPI) |
| What influences pain related impairment after bariatric surgery | up to 1 year after surgery | Measurement of patient reported outcome by the BPI (Brief Pain Inventory). |
Countries
Switzerland
Contacts
Primary ContactUlrike M Stamer, Prof. MD
Backup ContactMarkus Lüdi, MD
Outcome results
None listed