Postoperative Pain, AcutePAINNCT06363227
Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients
An observational study of Postoperative Pain, Acute, run by Schulthess Klinik.
Trial summary
The aim of this study is to examine the impact of implementing a standardized pain therapy protocol and their components on postoperative pain trajectories and postoperative outcomes such as increased opioid consumption and to compare it for different orthopaedic operations, i.e. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- Postoperative Pain, Acute
- What is being tested?
- Standardized pain management
- Type of treatment
- Surgery or procedure
- How many people
- 12,000 participants
- Where
- No sites listed yet
- Study dates
- May 2024to Apr 2025
- 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 16 to 99 years
- All sexes
- Child, Adult, Older adult
Study population: Patients undergoing elective major orthopedic or spine surgery at the Schulthess Clinic between 2020 and 2024.
Who may be able to join
- Patients undergoing primary hip and knee arthroplasties or revision surgery:CHOP Code: 81.51, 81.52, 81.52, 81.54
- Patients undergoing primary shoulder or revision surgery: CHOP codes: 81.80.11, 81.80.12, 83.64.11, 81.82.35, 81.82.45, 81.82.46, 81.82.47
- Patients undergoing major spine surgery: CHOP Code: 7A.6, 7A.7
Who cannot join
- Patients who did not sign general informed consent (for the Schulthess Clinic).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients A Quality Assessment in Major Orthopaedic and Spine Surgery
The aim of this study is to examine the impact of implementing a standardized pain therapy protocol and their components on postoperative pain trajectories and postoperative outcomes such as increased opioid consumption and to compare it for different orthopaedic operations, i.e. major shoulder, hip, knee und spine surgery.
Read the detailed description
A multimodal standardized pain management was implemented at the Schulthess Clinic in 2002, followed by the gradual introduction of a standardized ultrasound-guided perioperative regional anaesthesia program. Along with these measures, an improved preoperative screening process for patients at risk of increased post-operative pain has been installed and an improved individual pain assessment in the perioperative period has been introduced. This allowed for the creation of pain trajectories, which the pain team started to use to identify gaps in the management of different patient groups. An example of a trajectory group is shown in Figure 1. These pain trajectories have not yet been evaluated for the overall implementation cycle of the multimodal standardized pain management in order to further improve postoperative care especially for patients with a history of chronic pain and those prone to opioid overconsumption.We hypothesise that pain trajectories have changed significantly over the study period as standardised pain management has been implemented. We also hypothesise that patients with chronic pain and increased opioid consumption will have different pain trajectories compared to all other patients. However, we believe that the pain trajectories for different orthopaedic surgeries do not show much variation.
- Conditions
- Postoperative Pain, Acute
- Being tested
- Standardized pain management
- Keywords
- multimodal pain protocol, orthopedic surgery, opioids
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standardized pain managementProcedure or surgery
multimodal postoperative pain protocol
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative pain trajectories
Pain scores based on perioperative NRS = Numeric rating scales (0-10) prior to surgery on day of admission and during the postoperative period until discharge
Measured: 2021-2024
Increased risk for postoperative pain
Identification of risk factors
Measured: 2021-2024
Secondary outcomes (2)
Total amount of opioids administered
iv and po opioids given in the postoperative period
Measured: 2021-2024
Correlation of pain trajectories and patient reported outcome measures (e.g. postoperative nausea and vomiting)
Measured: 2021-2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study startMay 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionApr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Schulthess Klinik
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christoph Hofer, Schulthess Klinik
- Investigators
- Christoph K Hofer, MD, Principal investigator, Schulthess Klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363227
- Sponsor's protocol ID
- ANEST-0003
- Acronym
- PAIN
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients A Quality Assessment in Major Orthopaedic and Spine Surgery
- ClinicalTrials.gov ID
- NCT06363227
- Acronym / sponsor ID
- PAIN / ANEST-0003
- Conditions
- Postoperative Pain, Acute
- Keywords
- multimodal pain protocol, orthopedic surgery, opioids
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- Schulthess KlinikUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Apr 2025 (estimated)
- First posted
- 12 Apr 2024 (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.
The aim of this study is to examine the impact of implementing a standardized pain therapy protocol and their components on postoperative pain trajectories and postoperative outcomes such as increased opioid consumption and to compare it for different orthopaedic operations, i.e. major shoulder, hip, knee und spine surgery.
Detailed description
A multimodal standardized pain management was implemented at the Schulthess Clinic in 2002, followed by the gradual introduction of a standardized ultrasound-guided perioperative regional anaesthesia program. Along with these measures, an improved preoperative screening process for patients at risk of increased post-operative pain has been installed and an improved individual pain assessment in the perioperative period has been introduced. This allowed for the creation of pain trajectories, which the pain team started to use to identify gaps in the management of different patient groups. An example of a trajectory group is shown in Figure 1. These pain trajectories have not yet been evaluated for the overall implementation cycle of the multimodal standardized pain management in order to further improve postoperative care especially for patients with a history of chronic pain and those prone to opioid overconsumption.We hypothesise that pain trajectories have changed significantly over the study period as standardised pain management has been implemented. We also hypothesise that patients with chronic pain and increased opioid consumption will have different pain trajectories compared to all other patients. However, we believe that the pain trajectories for different orthopaedic surgeries do not show much variation.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 to 99 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing elective major orthopedic or spine surgery at the Schulthess Clinic between 2020 and 2024.
Key inclusion criteria (3 listed)
- Patients undergoing primary hip and knee arthroplasties or revision surgery:CHOP Code: 81.51, 81.52, 81.52, 81.54
- Patients undergoing primary shoulder or revision surgery: CHOP codes: 81.80.11, 81.80.12, 83.64.11, 81.82.35, 81.82.45, 81.82.46, 81.82.47
- Patients undergoing major spine surgery: CHOP Code: 7A.6, 7A.7
Key exclusion criteria (1 listed)
- Patients who did not sign general informed consent (for the Schulthess Clinic).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized pain managementmultimodal postoperative pain protocol | Procedure or surgery | – |
Primary outcome
Perioperative pain trajectories
Time frame: 2021-2024
Pain scores based on perioperative NRS = Numeric rating scales (0-10) prior to surgery on day of admission and during the postoperative period until discharge
Increased risk for postoperative pain
Time frame: 2021-2024
Identification of risk factors
2 secondary outcomes
Total amount of opioids administered
Time frame: 2021-2024
Correlation of pain trajectories and patient reported outcome measures (e.g. postoperative nausea and vomiting)
Time frame: 2021-2024
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
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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.
Christoph K Hofer, MD principal investigator
Schulthess Klinik
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, Acute, run by Schulthess Klinik.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christoph K Hofer, MD (+41795427965, christoph.hofer@kws.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative pain trajectories (time frame: 2021-2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2024.