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

NCT ID: NCT03133858

Last Updated: 2021-12-13

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-11-09
• Study Completion Date: 2021-11-28

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.

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.

Conditions

Pain; Delirium; Postoperative Cognitive Dysfunction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

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

Locations

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

Berlin, , Germany

Countries

Germany

References

Borck M, Wandrey JD, Spies C, Tafelski S. Sublingual sufentanil after orthopaedic and abdominal surgery: long-term outcome and safety. Perioper Med (Lond). 2025 Feb 28;14(1):23. doi: 10.1186/s13741-025-00506-y.

Reference Type: DERIVED

PMID: 40022238 (View on PubMed)

Other Identifiers

PainLong

Identifier Type: -

Identifier Source: org_study_id