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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03133858
• Other study ID #: PainLong
• Status: Completed
• Start date: November 9, 2017
• Est. completion date: November 28, 2021

Study information

• Verified date: December 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 28, 2021
• Est. primary completion date: December 14, 2020
• 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

Related Conditions & MeSH terms

• Chronic Pain
• Cognitive Dysfunction
• Delirium
• Pain
• Pain, Postoperative
• Postoperative Cognitive Complications
• Postoperative Cognitive Dysfunction

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

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