Pain Clinical Trial
Official title:
Longitudinal Cohort Study - for the Treatment of Acute Postoperative Pain and Postoperative Delirium, Postoperative Cognitive Dysfunctions, and Chronic Pain.
NCT number | NCT03133858 |
Other study ID # | PainLong |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 9, 2017 |
Est. completion date | November 28, 2021 |
Verified date | December 2021 |
Source | Charite University, Berlin, Germany |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | 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.
Status | Completed |
Enrollment | 80 |
Est. completion date | November 28, 2021 |
Est. primary completion date | December 14, 2020 |
Accepts healthy volunteers | |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin | Berlin |
Lead Sponsor | Collaborator |
---|---|
Charite University, Berlin, Germany |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Until the 7th postoperative day | |
Primary | 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. | Up to one year | |
Primary | Incidence of postoperative chronic pain | The DSF (German pain questionnaire) and Ease of Care (EOC) questionnaire will be used to assess pain. | Up to one year | |
Secondary | Time until fully Mobilization (walking) after elective surgery (days) | Until the 7th postoperative day | ||
Secondary | Time to first oral nutritional intake (days) | Until the 7th postoperative day | ||
Secondary | Patient satisfaction | Patient Global Assessment- patients overall satisfaction with procedure to reduce pain measured as 11-item likert scale | Until the 5th postoperative day | |
Secondary | Postoperative complications | Measurement includes adverse events of pain therapy | Until the 7th postoperative day | |
Secondary | Pain intensity | Numeric rating scale, mean of maximum and minimum- Course of patients pain intensity measured with 11-item likert scale | Until the 7th postoperative day | |
Secondary | Amount of administered analgetics | Until the 7th postoperative day | ||
Secondary | Duration until discharge | Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks | ||
Secondary | Costs of pain therapy | Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks | ||
Secondary | Duration of pain therapy | Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks | ||
Secondary | Quality of life questionnaire | Quality of life will be measured with the EQ5D | 3 months and 1 year after hospital discharge | |
Secondary | Intensive care unit length of stay | Participants will be followed for the duration of intensive care stay, an expected average of 1 week | ||
Secondary | Mortality | Up to one year |
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