- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06124170
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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
-
-
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
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 |
Intervention / Treatment |
---|---|
Total knee arthroplasty (TKA)
Total knee arthroplasty
|
propaganda and education on pain; Preemptive analgesia with celecoxib (200 mg bid) 2 days before surgery
Squeeze to expel blood (tourniquet); Before skin suture, 20 mL 0.5% ropivacaine was given subcutaneously for local infiltration anesthesia;
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
|
propaganda and education on pain; Preemptive analgesia with celecoxib (200 mg bid) 2 days before surgery
Squeeze to expel blood (tourniquet); Before skin suture, 20 mL 0.5% ropivacaine was given subcutaneously for local infiltration anesthesia;
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
|
propaganda and education on pain; Preemptive analgesia with celecoxib (200 mg bid) 2 days before surgery
Squeeze to expel blood (tourniquet); Before skin suture, 20 mL 0.5% ropivacaine was given subcutaneously for local infiltration anesthesia;
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
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
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
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
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)
March 1, 2016
Primary Completion (Actual)
March 2, 2022
Study Completion (Actual)
March 2, 2023
Study Registration Dates
First Submitted
November 4, 2023
First Submitted That Met QC Criteria
November 8, 2023
First Posted (Actual)
November 9, 2023
Study Record Updates
Last Update Posted (Actual)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 8, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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