An observational study in Pain, Delirium and Postoperative Cognitive Dysfunction, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-13.
Sponsored by Charite University, Berlin, Germany · Observational
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.
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.
1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.
This study's enrollment of 80 is below the median of 200 across 418 observational studies indexed under Delirium.
Browse Delirium studies →Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Male and female patients scheduled for elective surgical procedures in the fields of orthopedics, trauma surgery, gynecology, and urology, with planned patient-controlled analgesia used.
Exclusion Criteria:
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to one year
Time until fully Mobilization (walking) after elective surgery (days)
Time frame: Until the 7th postoperative day
Time to first oral nutritional intake (days)
Time frame: Until the 7th postoperative day
Patient satisfaction
Patient Global Assessment- patients overall satisfaction with procedure to reduce pain measured as 11-item likert scale
Time frame: Until the 5th postoperative day
Postoperative complications
Measurement includes adverse events of pain therapy
Time frame: 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
Time frame: Until the 7th postoperative day
Amount of administered analgetics
Time frame: Until the 7th postoperative day
Duration until discharge
Time frame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Costs of pain therapy
Time frame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Duration of pain therapy
Time frame: 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
Time frame: 3 months and 1 year after hospital discharge
Intensive care unit length of stay
Time frame: Participants will be followed for the duration of intensive care stay, an expected average of 1 week
Mortality
Time frame: Up to one year
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Charite University, Berlin, Germany