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.

Study Overview

• Status: Completed
• Conditions: Pain; Delirium; Postoperative Cognitive Dysfunction

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 Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensive care unit length of stay		Participants will be followed for the duration of intensive care stay, an expected average of 1 week
Time until fully Mobilization (walking) after elective surgery (days)		Until the 7th postoperative day
Time to first oral nutritional intake (days)		Until the 7th postoperative day
Patient satisfaction	Patient Global Assessment- patients overall satisfaction with procedure to reduce pain measured as 11-item likert scale	Until the 5th postoperative day
Postoperative complications	Measurement includes adverse events of pain therapy	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	Until the 7th postoperative day
Amount of administered analgetics		Until the 7th postoperative day
Duration until discharge		Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Costs of pain therapy		Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Duration of pain therapy		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	3 months and 1 year after hospital discharge
Mortality		Up to one year

Collaborators and Investigators

• Sponsor: 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 record dates

Study Major Dates

• Study Start (Actual): November 9, 2017
• Primary Completion (Actual): December 14, 2020
• Study Completion (Actual): November 28, 2021

Study Registration Dates

• First Submitted: April 24, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): December 13, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Cognition Disorders; Pain, Postoperative; Delirium; Chronic Pain; Cognitive Dysfunction; Postoperative Cognitive Complications
• Other Study ID Numbers: PainLong

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No