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Not yet recruitingNCT06363227PAINUpdated Apr 16, 2024

Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients

An observational study in Postoperative Pain, Acute, sponsored by Schulthess Klinik. Not yet recruiting. Open to participants aged 16 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-04-16.

Sponsored by Schulthess Klinik · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
12,000
Ages
16 Years to 99 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Postoperative Pain, Acute

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Keywords

  • multimodal pain protocol
  • orthopedic surgery
  • opioids
03

Who can participate

Ages eligible
16 Years to 99 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients undergoing elective major orthopedic or spine surgery at the Schulthess Clinic between 2020 and 2024.

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

Exclusion Criteria:

  • Patients who did not sign general informed consent (for the Schulthess Clinic).
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
12,000 participants (estimated)
Patient registry
No

Interventions

  • ProcedureStandardized pain management

    multimodal postoperative pain protocol

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2021-2024

  2. Increased risk for postoperative pain

    Identification of risk factors

    Time frame: 2021-2024

Secondary outcomes

  1. Total amount of opioids administered

    iv and po opioids given in the postoperative period

    Time frame: 2021-2024

  2. Correlation of pain trajectories and patient reported outcome measures (e.g. postoperative nausea and vomiting)

    Time frame: 2021-2024

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT06363227
Lead sponsor
Schulthess Klinik
Responsible party
Christoph Hofer (Head of Anesthesia, Professor, Principal Investigator, Schulthess Klinik) — Principal investigator
First posted
Apr 12, 2024
Start date
May 2024 (estimated)
Primary completion
Feb 2025 (estimated)
Completion
Apr 2025 (estimated)
Last update
Apr 16, 2024

Study contacts

Christoph K Hofer, MD
Contact
christoph.hofer@kws.ch
+41795427965
Julia Item, PhD
Contact
julia.item@kws.ch
+41443857976
Christoph K Hofer, MD
principal investigator · Schulthess Klinik

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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