Postoperative Pain After Implementation of Standardized Pain Therapy Management in Orthopaedic Patients (PAIN)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Postoperative Pain, Acute
• Intervention / Treatment: Procedure: Standardized pain management

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 Type: Observational
• Enrollment (Estimated): 12000

Contacts and Locations

• Study Contact: Name: Christoph K Hofer, MD; Phone Number: +41795427965; Email: christoph.hofer@kws.ch
• Study Contact Backup: Name: Julia Item, PhD; Phone Number: +41443857976; Email: julia.item@kws.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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).

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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)		2021-2024

Collaborators and Investigators

• Sponsor: Schulthess Klinik
• Investigators: Principal Investigator: Christoph K Hofer, MD, Schulthess Klinik

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 12, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: orthopedic surgery; opioids; multimodal pain protocol
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain
• Other Study ID Numbers: ANEST-0003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No