Postoperative Pain After Implementation of Standardized P... | NCT06363227

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

NCT06363227

Sponsor

Schulthess Klinik

Status

Unknown status

Last Update Posted

Apr 16, 2024Actual

Enrollment

12,000Estimated

Phase

Not provided

Conditions

Postoperative Pain, Acute

Interventions

Standardized pain management

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2024Estimated

Primary Completion Date

Feb 2025Estimated

Completion Date

Apr 2025Estimated

First Submitted Date

Apr 9, 2024

First Submission Date that Met QC Criteria

Apr 9, 2024

First Posted Date

Apr 12, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 12, 2024

Last Update Posted Date

Apr 16, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Christoph Hofer, Head of Anesthesia, Professor, Principal Investigator, Schulthess KlinikPrincipal Investigator

Lead Sponsor

Schulthess KlinikOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12,000Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Standardized pain management	Procedure	multimodal postoperative pain protocol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Total amount of opioids administered	iv and po opioids given in the postoperative period	2021-2024
Correlation of pain trajectories and patient reported outcome measures (e.g. postoperative nausea and vomiting)

Other Outcomes

Not provided

Eligibility Module

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).

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

99 Years

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christoph K Hofer, MD	Contact	+41795427965		christoph.hofer@kws.ch
Julia Item, PhD	Contact	+41443857976		julia.item@kws.ch

Overall Officials

Name	Affiliation	Role
Christoph K Hofer, MD	Schulthess Klinik	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided