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

NCT03133858 | Completed

• 1 other identifier: PainLong
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Delirium; Postoperative Cognitive Dysfunction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• 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

  Until the 5th postoperative day

• Postoperative complications

  Until the 7th postoperative day

• Pain intensity

  Until the 7th postoperative day

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients undergoing elective surgery with planned use of a patient-controlled analgesia system for postoperative pain therapy

You may not qualify if:

• Children (\<18 years of age),
• Pregnancy and lactation
• Emergency surgery
• Accommodation in an institution due to an official or judicial order
• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

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

Berlin, 13353, Germany

Location

Related Publications (1)

• 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.

  PMID: 40022238 DERIVED

MeSH Terms

Conditions

Pain; Delirium; Postoperative Cognitive Complications

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Confusion; Neurobehavioral Manifestations; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Cognitive Dysfunction; Cognition Disorders

Study Officials

• Claudia Spies, MD, Prof.

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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin

Study Record Dates

• First Submitted: April 24, 2017
• First Posted: April 28, 2017
• Study Start: November 9, 2017
• Primary Completion: December 14, 2020
• Study Completion: November 28, 2021
• Last Updated: December 13, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)