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

Not yet recruiting

• Conditions: Postoperative Pain, Acute

• Registration Number: NCT06363227
• Lead Sponsor: Schulthess Klinik

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.

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Last Update Submitted: 2024-04-12
• Last Update Posted: 2024-04-16
• Study Start: 2024-05
• Primary Completion: 2025-02
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 12000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Increased risk for postoperative pain	2021-2024	Identification of risk factors
Perioperative pain trajectories	2021-2024	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

Secondary Outcome Measures

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