NCT06363227

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2024

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 9, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 12, 2024

Completed
19 days until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

9 months

First QC Date

April 9, 2024

Last Update Submit

April 12, 2024

Conditions

Keywords

multimodal pain protocolorthopedic surgeryopioids

Outcome Measures

Primary Outcomes (2)

  • 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

    2021-2024

  • Increased risk for postoperative pain

    Identification of risk factors

    2021-2024

Secondary Outcomes (2)

  • Total amount of opioids administered

    2021-2024

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

    2021-2024

Interventions

multimodal postoperative pain protocol

Eligibility Criteria

Age16 Years - 99 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Christoph K Hofer, MD

    Schulthess Klinik

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christoph K Hofer, MD

CONTACT

Julia Item, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Anesthesia, Professor, Principal Investigator

Study Record Dates

First Submitted

April 9, 2024

First Posted

April 12, 2024

Study Start

May 1, 2024

Primary Completion

February 1, 2025

Study Completion

April 1, 2025

Last Updated

April 16, 2024

Record last verified: 2024-04