Clinical trial NCT06363227: Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients
Official title: Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients A Quality Assessment in Major Orthopaedic and Spine Surgery
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Postoperative Pain, Acute
Keywords: multimodal pain protocol
orthopedic surgery
opioids
Lead sponsor: Schulthess Klinik
Sponsor class: OTHER
First posted: 2024-04-12
Enrollment: 12000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective major orthopedic or spine surgery at the Schulthess Clinic between 2020 and 2024.

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

- Patients who did not sign general informed consent (for the Schulthess Clinic).

Primary outcomes:
measure: Perioperative pain trajectories
timeFrame: 2021-2024
measure: Increased risk for postoperative pain
timeFrame: 2021-2024
Secondary outcomes:
measure: Total amount of opioids administered
timeFrame: 2021-2024
measure: Correlation of pain trajectories and patient reported outcome measures (e.g. postoperative nausea and vomiting)
timeFrame: 2021-2024
Other outcomes:
Locations:
Study officials:
affiliation: Schulthess Klinik
name: Christoph K Hofer, MD
role: PRINCIPAL_INVESTIGATOR
References: