PainNCT03133858
Longitudinal Cohort Study - for the Treatment of Acute Postoperative Pain and Postoperative Delirium, Postoperative Cognitive Dysfunctions, and Chronic Pain.
An observational study of Pain and Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Delirium, Postoperative Cognitive Dysfunction
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 9 Nov 2017to 28 Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients undergoing elective surgery with planned use of a patient-controlled analgesia system for postoperative pain therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
Berlin, 13353
About this study
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.
Read the 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
- Medical subject headings
- Pain, Delirium, Postoperative Cognitive Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Up to one year
Secondary outcomes (12)
Time until fully Mobilization (walking) after elective surgery (days)
Measured: Until the 7th postoperative day
Time to first oral nutritional intake (days)
Measured: Until the 7th postoperative day
Patient satisfaction
Patient Global Assessment- patients overall satisfaction with procedure to reduce pain measured as 11-item likert scale
Measured: Until the 5th postoperative day
Postoperative complications
Measurement includes adverse events of pain therapy
Measured: 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
Measured: Until the 7th postoperative day
Amount of administered analgetics
Measured: Until the 7th postoperative day
Duration until discharge
Measured: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Costs of pain therapy
Measured: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Duration of pain therapy
Measured: 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
Measured: 3 months and 1 year after hospital discharge
Intensive care unit length of stay
Measured: Participants will be followed for the duration of intensive care stay, an expected average of 1 week
Mortality
Measured: Up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start9 Nov 2017
- Primary completion14 Dec 2020
- Study completion28 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133858
- Sponsor's protocol ID
- PainLong
- Status last verified
- Dec 2021
- First submitted
- 24 Apr 2017
- Last updated
- 13 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40022238
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Cohort Study - for the Treatment of Acute Postoperative Pain and Postoperative Delirium, Postoperative Cognitive Dysfunctions, and Chronic Pain.
- ClinicalTrials.gov ID
- NCT03133858
- Acronym / sponsor ID
- PainLong
- Conditions
- Pain, Delirium, Postoperative Cognitive Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 14 Dec 2020 (actual)
- Study completion
- 28 Nov 2021 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients undergoing elective surgery with planned use of a patient-controlled analgesia system for postoperative pain therapy
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of postoperative delirium (POD)
Time frame: Until the 7th postoperative day
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.
Incidence of postoperative cognitive deficit (POCD)
Time frame: Up to one year
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.
Incidence of postoperative chronic pain
Time frame: Up to one year
The DSF (German pain questionnaire) and Ease of Care (EOC) questionnaire will be used to assess pain.
12 secondary outcomes
Time until fully Mobilization (walking) after elective surgery (days)
Time frame: Until the 7th postoperative day
Time to first oral nutritional intake (days)
Time frame: Until the 7th postoperative day
Patient satisfaction
Time frame: Until the 5th postoperative day
Postoperative complications
Time frame: Until the 7th postoperative day
Pain intensity
Time frame: Until the 7th postoperative day
Amount of administered analgetics
Time frame: Until the 7th postoperative day
Duration until discharge
Time frame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Costs of pain therapy
Time frame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Duration of pain therapy
Time frame: Participants will be followed for the duration of hospital length of stay, an expected average of 3 weeks
Quality of life questionnaire
Time frame: 3 months and 1 year after hospital discharge
Intensive care unit length of stay
Time frame: Participants will be followed for the duration of intensive care stay, an expected average of 1 week
Mortality
Time frame: Up to one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2021.
- Derived from this study: PubMed 40022238Borck 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.
- Individual participant dataSharing planned: No
Related trials for Pain
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Department of Anesthesiology and Intensive Care Medicine CVK/CCM, Charité - University Medicine Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Delirium, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of postoperative delirium (POD) (time frame: Until the 7th postoperative day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03133858, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2021.