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Completed

NCT Number: NCT03133858

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin

Berlin, 13353, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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

  1. Time until fully Mobilization (walking) after elective surgery (days)

    Time frame: Until the 7th postoperative day

  2. Time to first oral nutritional intake (days)

    Time frame: Until the 7th postoperative day

  3. Patient satisfaction

    Time frame: Until the 5th postoperative day

    Patient Global Assessment- patients overall satisfaction with procedure to reduce pain measured as 11-item likert scale

  4. Postoperative complications

    Time frame: Until the 7th postoperative day

    Measurement includes adverse events of pain therapy

  5. Pain intensity

    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

  6. Amount of administered analgetics

    Time frame: Until the 7th postoperative day

  7. Duration until discharge

    Time frame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks

  8. Costs of pain therapy

    Time frame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks

  9. Duration of pain therapy

    Time frame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks

  10. Quality of life questionnaire

    Time frame: 3 months and 1 year after hospital discharge

    Quality of life will be measured with the EQ5D

  11. 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

  12. Mortality

    Time frame: Up to one year

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Apr 28, 2017
Registry last updated
Dec 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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