Longitudinal Cohort Study - for the Treatment of Acute Postoperative Pain and Postoperative Delirium, Postoperative Cognitive Dysfunctions, and Chronic Pain.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Charite University, Berlin, Germany
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Incidence of postoperative delirium (POD)
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
Claudia Spies
Head of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
Charite University, Berlin, Germany
Eligibility Criteria
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
Outcomes
Primary Outcomes
Incidence of postoperative delirium (POD)
Time Frame: Until the 7th postoperative day
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.
Incidence of postoperative cognitive deficit (POCD)
Time Frame: Up to one year
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.
Incidence of postoperative chronic pain
Time Frame: Up to one year
The DSF (German pain questionnaire) and Ease of Care (EOC) questionnaire will be used to assess pain.
Secondary Outcomes
- Mortality(Up to one year)
- Postoperative complications(Until the 7th postoperative day)
- Time to first oral nutritional intake (days)(Until the 7th postoperative day)
- Costs of pain therapy(Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks)
- Time until fully Mobilization (walking) after elective surgery (days)(Until the 7th postoperative day)
- Quality of life questionnaire(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)
- 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)
- Duration of pain therapy(Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks)
- Patient satisfaction(Until the 5th postoperative day)
- Pain intensity(Until the 7th postoperative day)