Longitudinal Cohort Study - for the Treatment of Acute Postoperative Pain and Postoperative Delirium, Postoperative Cognitive Dysfunctions, and Chronic Pain.

Study Overview
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Brief Summary
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Adequate pain therapy is important aspect of perioperative care. Sequelae of inadequate pain management are patient dissatisfaction, post-operative nausea and vomiting (PONV), inadequate nutrition, lack of mobilization, and an increased risk for the development of further complications, such as postoperative delirium (POD). The use of patient-controlled analgesia (PCA) systems, which allow patients to self-administer analgesics, has improved pain management. Conventional i.v. PCA and the non-invasive administration of sufentanil sublingual tablets (ZALVISO®) are available. The aim of this investigation is to study patient controlled analgesia systems and to examine the incidence of POD, POCD and postoperative pain.

Detailed Description
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There are strong evidence-based recommendations for an appropriate assessment and treatment of postoperative pain. Due to the complex and subjective nature of pain, an adequate pain therapy is an extremely challenging task, and the under- or overdosing of analgesics are common. An inadequate pain therapy leads to patient dissatisfaction, post-operative nausea and vomiting (PONV), inadequate nutrition, lack of mobilization, and an increased risk for the development of further complications, such as postoperative delirium (POD). Other long-term consequences of an insufficient postoperative analgesia include the chronification of pain and post-traumatic stress disorder (PTSD). Conversely, excessive opioid therapy may be associated with increased risk of POD. Subsequently, patients with POD have an increased risk for the consecutive development of postoperative cognitive dysfunction (POCD). The latter is marked by a progressive and permanent loss of cognitive abilities, which can ultimately lead to dementia. The use of patient-controlled analgesia (PCA) systems, which allow patients to self-administer analgesics, has been an improvement in the prevention of under- and overdosage of analgesics. Currently, there are two systems available: Conventional i.v. PCA with patients being dependent on an i.v. line and a PCA-pump and a patient-controlled, non-invasive administration of sufentanil sublingual tablets (ZALVISO®). The aim of this investigation is to study patient controlled analgesia systems and to examine the incidence of POD, POCD and postoperative pain.

Official Title
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Longitudinal Cohort Study - for the Treatment of Acute Postoperative Pain and Postoperative Delirium, Postoperative Cognitive Dysfunctions, and Chronic Pain.

Conditions
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Pain, Delirium, Postoperative Cognitive Dysfunction

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective surgery with planned use of a patient-controlled analgesia system for postoperative pain therapy Exclusion Criteria: Children (<18 years of age), Pregnancy and lactation Emergency surgery Accommodation in an institution due to an official or judicial order Participation in other clinical studies 30 days before study inclusion and during the study period Refusal of the patient Chronic opioid therapy > 3 months before surgery with an oral morphine sulfate equivalent >20mg/day Lacking willingness to save and hand out pseudonymized data within the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of postoperative delirium (POD) | The Nu-DESC (Nursing Delirium Screening Scale) and CAM-ICU (Confusion Assessment Method for the Intensive Care Unit) will be used as scoring systems to detect POD. | Until the 7th postoperative day | 
| Incidence of postoperative cognitive deficit (POCD) | The neuropsychological assessment will be performed at preoperative baseline until postoperative day 7, three-months and 1-year follow-up. In order to correct change in cognitive performance for practice effects, a group of non-surgical control subjects from the POCD Register (EA1/104/16) will also be evaluated with the cognitive test battery. The control subjects will be matched to the study group regarding health status, surgery and age. | Up to one year | 
| Incidence of postoperative chronic pain | The DSF (German pain questionnaire) and Ease of Care (EOC) questionnaire will be used to assess pain. | Up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time until fully Mobilization (walking) after elective surgery (days) |  | Until the 7th postoperative day | 
| Time to first oral nutritional intake (days) |  | Until the 7th postoperative day | 
| Patient satisfaction | Patient Global Assessment- patients overall satisfaction with procedure to reduce pain measured as 11-item likert scale | Until the 5th postoperative day | 
| Postoperative complications | Measurement includes adverse events of pain therapy | Until the 7th postoperative day | 
| Pain intensity | Numeric rating scale, mean of maximum and minimum- Course of patients pain intensity measured with 11-item likert scale | Until the 7th postoperative day | 
| Amount of administered analgetics |  | Until the 7th postoperative day | 
| Duration until discharge |  | Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks | 
| Costs of pain therapy |  | Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks | 
| Duration of pain therapy |  | Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks | 
| Quality of life questionnaire | Quality of life will be measured with the EQ5D | 3 months and 1 year after hospital discharge | 
| Intensive care unit length of stay |  | Participants will be followed for the duration of intensive care stay, an expected average of 1 week | 
| Mortality |  | Up to one year |