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

Sponsor
Charite University, Berlin, Germany (Other)
Overall Status
Completed
CT.gov ID
NCT03133858
Collaborator
(none)
80
1
48.6
1.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    80 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Longitudinal Cohort Study - for the Treatment of Acute Postoperative Pain and Postoperative Delirium, Postoperative Cognitive Dysfunctions, and Chronic Pain.
    Actual Study Start Date :
    Nov 9, 2017
    Actual Primary Completion Date :
    Dec 14, 2020
    Actual Study Completion Date :
    Nov 28, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Incidence of postoperative delirium (POD) [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) [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 [Up to one year]

      The DSF (German pain questionnaire) and Ease of Care (EOC) questionnaire will be used to assess pain.

    Secondary Outcome Measures

    1. Time until fully Mobilization (walking) after elective surgery (days) [Until the 7th postoperative day]

    2. Time to first oral nutritional intake (days) [Until the 7th postoperative day]

    3. Patient satisfaction [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 [Until the 7th postoperative day]

      Measurement includes adverse events of pain therapy

    5. Pain intensity [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 [Until the 7th postoperative day]

    7. Duration until discharge [Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks]

    8. Costs of pain therapy [Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks]

    9. Duration of pain therapy [Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks]

    10. Quality of life questionnaire [3 months and 1 year after hospital discharge]

      Quality of life will be measured with the EQ5D

    11. Intensive care unit length of stay [Participants will be followed for the duration of intensive care stay, an expected average of 1 week]

    12. Mortality [Up to one year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin Berlin Germany 13353

    Sponsors and Collaborators

    • Charite University, Berlin, Germany

    Investigators

    • Study Director: Claudia Spies, MD, Prof., Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Claudia Spies, Head of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin, Charite University, Berlin, Germany
    ClinicalTrials.gov Identifier:
    NCT03133858
    Other Study ID Numbers:
    • PainLong
    First Posted:
    Apr 28, 2017
    Last Update Posted:
    Dec 13, 2021
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 13, 2021