Knee OsteoarthritisNCT06124170
Improved Pain Management in Knee Osteoarthritis-related Surgeries
An observational study of Knee Osteoarthritis and Total Knee Arthroplasty, run by Peng Liu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Total Knee Arthroplasty, Unicompartmental Knee Arthroplasty
- What is being tested?
- Preoperative pain managment, Intraoperative pain managment and Postoperative pain managment
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 714 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2016to 2 Mar 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- first knee surgery were 50-80 years old had complete clinical and follow-up data
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty, Unicompartmental Knee Arthroplasty, High Tibial Osteotomy, Pain Management
- Being tested
- Preoperative pain managment, Intraoperative pain managment, Postoperative pain managment
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative pain managmentProcedure or surgery
propaganda and education on pain; Preemptive analgesia with celecoxib (200 mg bid) 2 days before surgery
Intraoperative pain managmentProcedure or surgery
Squeeze to expel blood (tourniquet); Before skin suture, 20 mL 0.5% ropivacaine was given subcutaneously for local infiltration anesthesia;
Postoperative pain managmentProcedure or surgery
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 ‡
| Study group | Role | What they receive |
|---|---|---|
| Total knee arthroplasty (TKA) | Total knee arthroplasty Receives: Procedure: Preoperative pain managment; Procedure: Intraoperative pain managment; Procedure: Postoperative pain managment | |
| Unicompartmental knee arthroplasty (UKA) | Unicompartmental knee arthroplasty Receives: Procedure: Preoperative pain managment; Procedure: Intraoperative pain managment; Procedure: Postoperative pain managment | |
| High tibial osteotomy (HTO) | High tibial osteotomy Receives: Procedure: Preoperative pain managment; Procedure: Intraoperative pain managment; Procedure: Postoperative pain managment |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analogue score (VAS)
visual analogue score (VAS)
Measured: 24 hours after surgery
visual analogue score (VAS)
visual analogue score (VAS)
Measured: 72 hours after surgery
Secondary outcomes (4)
Quadriceps muscle strength
Quadriceps muscle strength
Measured: 24 hours after surgery
Quadriceps muscle strength
Quadriceps muscle strength
Measured: 72 hours after surgery
Scope of activities to knee joint
Scope of activities to knee joint
Measured: 24 hours after surgery
Scope of activities to knee joint
Scope of activities to knee joint
Measured: 72 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start1 Mar 2016
- Primary completion2 Mar 2022
- Study completion2 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 714 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peng Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peng Liu, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06124170
- Sponsor's protocol ID
- 2023-414
- Status last verified
- Nov 2023
- First submitted
- 4 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Continuously Improved Pain Management in Knee Osteoarthritis-related Surgeries
- ClinicalTrials.gov ID
- NCT06124170
- Acronym / sponsor ID
- 2023-414
- Conditions
- Knee Osteoarthritis, Total Knee Arthroplasty, Unicompartmental Knee Arthroplasty, High Tibial Osteotomy, Pain Management
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 714 participants (actual)
- Lead sponsor
- Peng LiuUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 2 Mar 2023 (actual)
- First posted
- 9 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total knee arthroplasty (TKA) | – | Procedure: Preoperative pain managment, Procedure: Intraoperative pain managment, Procedure: Postoperative pain managmentTotal knee arthroplasty |
| Unicompartmental knee arthroplasty (UKA) | – | Procedure: Preoperative pain managment, Procedure: Intraoperative pain managment, Procedure: Postoperative pain managmentUnicompartmental knee arthroplasty |
| High tibial osteotomy (HTO) | – | Procedure: Preoperative pain managment, Procedure: Intraoperative pain managment, Procedure: Postoperative pain managmentHigh tibial osteotomy |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- first knee surgery were 50-80 years old had complete clinical and follow-up data
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preoperative pain managmentpropaganda and education on pain; Preemptive analgesia with celecoxib (200 mg bid) 2 days before surgery | Procedure or surgery | High tibial osteotomy (HTO), Total knee arthroplasty (TKA), Unicompartmental knee arthroplasty (UKA) |
| Intraoperative pain managmentSqueeze to expel blood (tourniquet); Before skin suture, 20 mL 0.5% ropivacaine was given subcutaneously for local infiltration anesthesia; | Procedure or surgery | High tibial osteotomy (HTO), Total knee arthroplasty (TKA), Unicompartmental knee arthroplasty (UKA) |
| Postoperative pain managmentThe 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 ‡ | Procedure or surgery | High tibial osteotomy (HTO), Total knee arthroplasty (TKA), Unicompartmental knee arthroplasty (UKA) |
Primary outcome
visual analogue score (VAS)
Time frame: 24 hours after surgery
visual analogue score (VAS)
visual analogue score (VAS)
Time frame: 72 hours after surgery
visual analogue score (VAS)
4 secondary outcomes
Quadriceps muscle strength
Time frame: 24 hours after surgery
Quadriceps muscle strength
Time frame: 72 hours after surgery
Scope of activities to knee joint
Time frame: 24 hours after surgery
Scope of activities to knee joint
Time frame: 72 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Total Knee Arthroplasty, run by Peng Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual analogue score (VAS) (time frame: 24 hours after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.