Clinical trial NCT03133858: Longitudinal Cohort Study - for the Treatment of Acute Postoperative Pain and Postoperative Delirium, Postoperative Cognitive Dysfunctions, and Chronic Pain.
Official title: Longitudinal Cohort Study - for the Treatment of Acute Postoperative Pain and Postoperative Delirium, Postoperative Cognitive Dysfunctions, and Chronic Pain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Delirium
Postoperative Cognitive Dysfunction
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Incidence of postoperative delirium (POD)
timeFrame: Until the 7th postoperative day
measure: Incidence of postoperative cognitive deficit (POCD)
timeFrame: Up to one year
measure: Incidence of postoperative chronic pain
timeFrame: Up to one year
Secondary outcomes:
measure: Time until fully Mobilization (walking) after elective surgery (days)
timeFrame: Until the 7th postoperative day
measure: Time to first oral nutritional intake (days)
timeFrame: Until the 7th postoperative day
measure: Patient satisfaction
timeFrame: Until the 5th postoperative day
measure: Postoperative complications
timeFrame: Until the 7th postoperative day
measure: Pain intensity
timeFrame: Until the 7th postoperative day
measure: Amount of administered analgetics
timeFrame: Until the 7th postoperative day
measure: Duration until discharge
timeFrame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
measure: Costs of pain therapy
timeFrame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
measure: Duration of pain therapy
timeFrame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
measure: Quality of life questionnaire
timeFrame: 3 months and 1 year after hospital discharge
measure: Intensive care unit length of stay
timeFrame: Participants will be followed for the duration of intensive care stay, an expected average of 1 week
measure: Mortality
timeFrame: Up to one year
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
Study officials:
affiliation: Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
name: Claudia Spies, MD, Prof.
role: STUDY_DIRECTOR
References: