NCT06124170

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
714

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2023

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 4, 2023

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

6 years

First QC Date

November 4, 2023

Last Update Submit

November 8, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • visual analogue score (VAS)

    visual analogue score (VAS)

    24 hours after surgery

  • visual analogue score (VAS)

    visual analogue score (VAS)

    72 hours after surgery

Secondary Outcomes (4)

  • Quadriceps muscle strength

    24 hours after surgery

  • Quadriceps muscle strength

    72 hours after surgery

  • Scope of activities to knee joint

    24 hours after surgery

  • Scope of activities to knee joint

    72 hours after surgery

Other Outcomes (4)

  • Self-Rating Anxiety Scale (SAS)

    24 hours after surgery

  • Self-Rating Anxiety Scale (SAS)

    72 hours after surgery

  • Self-Rating Depression Scale (SDS)

    24 hours after surgery

  • +1 more other outcomes

Study Arms (3)

Total knee arthroplasty (TKA)

Total knee arthroplasty

Procedure: Preoperative pain managmentProcedure: Intraoperative pain managmentProcedure: Postoperative pain managment

Unicompartmental knee arthroplasty (UKA)

Unicompartmental knee arthroplasty

Procedure: Preoperative pain managmentProcedure: Intraoperative pain managmentProcedure: Postoperative pain managment

High tibial osteotomy (HTO)

High tibial osteotomy

Procedure: Preoperative pain managmentProcedure: Intraoperative pain managmentProcedure: Postoperative pain managment

Interventions

propaganda and education on pain; Preemptive analgesia with celecoxib (200 mg bid) 2 days before surgery

High tibial osteotomy (HTO)Total knee arthroplasty (TKA)Unicompartmental knee arthroplasty (UKA)

Squeeze to expel blood (tourniquet); Before skin suture, 20 mL 0.5% ropivacaine was given subcutaneously for local infiltration anesthesia;

High tibial osteotomy (HTO)Total knee arthroplasty (TKA)Unicompartmental knee arthroplasty (UKA)

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)Total knee arthroplasty (TKA)Unicompartmental knee arthroplasty (UKA)

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sichuan Provincial People's Hospital

Chengdu, Sichuan, 610072, China

Location

MeSH Terms

Conditions

Osteoarthritis, KneeAgnosia

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesPerceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 4, 2023

First Posted

November 9, 2023

Study Start

March 1, 2016

Primary Completion

March 2, 2022

Study Completion

March 2, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations