Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
Berlin, 13353, Germany
NCT Number: NCT03133858
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.
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Notify Me18 year and older
All sexes
Observational
Berlin, 13353, Germany
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.
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: Up to one year
The DSF (German pain questionnaire) and Ease of Care (EOC) questionnaire will be used to assess pain.
Time frame: Until the 7th postoperative day
Time frame: Until the 7th postoperative day
Time frame: Until the 5th postoperative day
Patient Global Assessment- patients overall satisfaction with procedure to reduce pain measured as 11-item likert scale
Time frame: Until the 7th postoperative day
Measurement includes adverse events of pain therapy
Time frame: Until the 7th postoperative day
Numeric rating scale, mean of maximum and minimum- Course of patients pain intensity measured with 11-item likert scale
Time frame: Until the 7th postoperative day
Time frame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Time frame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Time frame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Time frame: 3 months and 1 year after hospital discharge
Quality of life will be measured with the EQ5D
Time frame: Participants will be followed for the duration of intensive care stay, an expected average of 1 week
Time frame: Up to one year
Charite University, Berlin, Germany
Other
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