Improved Pain Management in Knee Osteoarthritis-related Surgeries

November 8, 2023 updated by: Peng Liu

Evaluating the Effectiveness of Continuously Improved Pain Management in Knee Osteoarthritis-related Surgeries

In recent years, pain management coordinated with enhanced recovery after surgery (ERAS) has been widely applied and rapidly developed in orthopedics, showing promising prospects. Since 2016, our hospital has used a series of continuously improved pain management schemes for patients with knee OA who underwent total knee arthroplasty (TKA), unicompartmental knee arthroplasty (UKA), and high tibial osteotomy (HTO). Here, we retrospectively analyze these patients' clinical data to compare the effects of different pain intervention measures during the perioperative period on postoperative pain, functional exercise, hospital stay, and prognosis of the three surgical methods in an attempt to provide a feasible solution for pain management of these patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We retrospectively analyzed the clinical data of patients with knee osteoarthritis (OA) who received surgical treatment to provide a feasible solution for perioperative pain management of these patients. The medical records of 714 patients with knee OA who had undergone total knee arthroplasty (n=551), unicompartmental knee arthroplasty (n=92) and high tibial osteotomy (n=71) were retrospectively analyzed and the cases were divided into Groups A, B, and C, according to the continuously optimized pain management. Clinical data including anesthesia grade, surgery time, functional exercise, hospital stay, pain, emotion, complications and prognosis were compared.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
714

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, 610072
        • Sichuan Provincial People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The medical records of 714 patients (142 men, 40 women; mean age: 38.5 years; age range: 18-64 years) with moderate or severe knee OA who had undergone TKA (n=551), UKA (n=92), or HTO (n=71) in a group of joint surgery at Sichuan Provincial People's Hospital between March 2016 and February 2022 were retrospectively analyzed. Clinical data, including age, weight, height, anesthesia grade, surgery, and time, as well as continuously improved perioperative pain management measures, were recorded.

Description

Inclusion Criteria:

  • first knee surgery were 50-80 years old had complete clinical and follow-up data

Exclusion Criteria:

  • American Society of Anesthesiologists Physical Status grade≥4 comorbidity with three or more systemic diseases long-term anxiety and depression, contraindications of painkillers, long-term alcoholism, or taking painkillers concomitant limb pain caused by spinal degeneration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Total knee arthroplasty (TKA)
Total knee arthroplasty
Procedure: Preoperative pain managment
propaganda and education on pain; Preemptive analgesia with celecoxib (200 mg bid) 2 days before surgery
Procedure: Intraoperative pain managment
Squeeze to expel blood (tourniquet); Before skin suture, 20 mL 0.5% ropivacaine was given subcutaneously for local infiltration anesthesia;
Procedure: Postoperative pain managment
The intravenous analgesia pump was placed until 48 h after surgery;On the second day after surgery, celecoxib (200 mg bid) was administered orally, and buprenorphine transdermal patch was applied externally until hospital discharge;FNB catheter was placed under the guidance of ultrasound and connected with an analgesic pump, the anesthesia lasted until 48 h after surgery ‡
Unicompartmental knee arthroplasty (UKA)
Unicompartmental knee arthroplasty
Procedure: Preoperative pain managment
propaganda and education on pain; Preemptive analgesia with celecoxib (200 mg bid) 2 days before surgery
Procedure: Intraoperative pain managment
Squeeze to expel blood (tourniquet); Before skin suture, 20 mL 0.5% ropivacaine was given subcutaneously for local infiltration anesthesia;
Procedure: Postoperative pain managment
The intravenous analgesia pump was placed until 48 h after surgery;On the second day after surgery, celecoxib (200 mg bid) was administered orally, and buprenorphine transdermal patch was applied externally until hospital discharge;FNB catheter was placed under the guidance of ultrasound and connected with an analgesic pump, the anesthesia lasted until 48 h after surgery ‡
High tibial osteotomy (HTO)
High tibial osteotomy
Procedure: Preoperative pain managment
propaganda and education on pain; Preemptive analgesia with celecoxib (200 mg bid) 2 days before surgery
Procedure: Intraoperative pain managment
Squeeze to expel blood (tourniquet); Before skin suture, 20 mL 0.5% ropivacaine was given subcutaneously for local infiltration anesthesia;
Procedure: Postoperative pain managment
The intravenous analgesia pump was placed until 48 h after surgery;On the second day after surgery, celecoxib (200 mg bid) was administered orally, and buprenorphine transdermal patch was applied externally until hospital discharge;FNB catheter was placed under the guidance of ultrasound and connected with an analgesic pump, the anesthesia lasted until 48 h after surgery ‡

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
visual analogue score (VAS)
Time Frame: 24 hours after surgery
visual analogue score (VAS)
24 hours after surgery
visual analogue score (VAS)
Time Frame: 72 hours after surgery
visual analogue score (VAS)
72 hours after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quadriceps muscle strength
Time Frame: 24 hours after surgery
Quadriceps muscle strength
24 hours after surgery
Quadriceps muscle strength
Time Frame: 72 hours after surgery
Quadriceps muscle strength
72 hours after surgery
Scope of activities to knee joint
Time Frame: 24 hours after surgery
Scope of activities to knee joint
24 hours after surgery
Scope of activities to knee joint
Time Frame: 72 hours after surgery
Scope of activities to knee joint
72 hours after surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Rating Anxiety Scale (SAS)
Time Frame: 24 hours after surgery
Self-Rating Anxiety Scale (SAS)
24 hours after surgery
Self-Rating Anxiety Scale (SAS)
Time Frame: 72 hours after surgery
Self-Rating Anxiety Scale (SAS)
72 hours after surgery
Self-Rating Depression Scale (SDS)
Time Frame: 24 hours after surgery
Self-Rating Depression Scale (SDS)
24 hours after surgery
Self-Rating Depression Scale (SDS)
Time Frame: 72 hours after surgery
Self-Rating Depression Scale (SDS)
72 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Peng Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 2, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-414

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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