Arthroplasty, Replacement, KneeNCT05439343
Adductor Canal Block and Multimodal Local Infiltration Analgesia in Patients Receiving Total Knee Arthroplasty
A study testing Pain scores (numerical rating scale at rest and motion) and Secondary outcomes in people with Arthroplasty, Replacement, Knee and Analgesia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literatures. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Analgesia, Rehabilitation
- What is being tested?
- Pain scores (numerical rating scale at rest and motion) and Secondary outcomes
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteTaiwan
- Study dates
- 15 Oct 2018to 31 Mar 2023
- Phase
- Interventional
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients were eligible to enter the study if their age are between 20 to 90 years old and scheduled for bilateral TKA secondary to osteoarthritis.
Who cannot join
- American Society of Anesthesiologists (ASA) physical status class IV-V, history of abnormal liver enzymes, hepatic failure, renal insufficiency, cardiac failure, organ transplant, neuropathic pain, history of stroke or major neurological deficit, coagulopathy, thrombocytopenia, sensory and motor disorders in lower limb, previous drug dependency, chronic use of opioids, allergy to local anesthetics and drug used in experiment, inability to walk independently, inability to comprehend pain assessment and patients refusing to have spinal anesthesia or enter this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Analgesic Efficacy and Functional Improvement of Adductor Canal Block and Multimodal Local Infiltration Analgesia for Patients After Bilateral Total Knee Arthroplasty
Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literatures. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay. By reducing hospital stay, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.
Read the detailed description
Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literature. Some patients choose to receive bilateral TKA simultaneously to avoid repetitive surgery and anesthesia, and are supposed to suffer more than those receiving unilateral TKA. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay and postoperative complications. By reducing the length of in-hospital stay and post-operative complication, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after bilateral simultaneous TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, muscle power in knee adduction/abduction movement, and time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.
- Conditions
- Arthroplasty, Replacement, Knee, Analgesia, Rehabilitation
- Being tested
- Pain scores (numerical rating scale at rest and motion), Secondary outcomes
- Keywords
- Arthroplasty, Replacement, Knee, adductor canal block, Local infiltration, Regional analgesia, Pain, Postoperative, Rehabilitation, Muscle power
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain scores (numerical rating scale at rest and motion)Other
As the primary outcome of the present clinical study, pain scores will be assessed with numerical rating scale at both rest and motion on both knees.
Secondary outcomesOther
Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale will be used as the questionnaires for functional assessment. Rehabilitation physiotherapy will be assessed with knee range of motion (both active and maximal passive), muscle power at abduction and adduction, single leg stance test, six-minute walk test for assessment of the functional recovery of knee joints.
| Study group | Role | What they receive |
|---|---|---|
| Adductor canal block | Experimental | Allocation of which limb is to receive adductor canal block is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, adductor canal block will be performed by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following skin infiltration, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through a 3-inch, 23-gauge, short bevel block needle. Receives: Other: Pain scores (numerical rating scale at rest and motion); Other: Secondary outcomes |
| Local infiltration | Experimental | Allocation of the other limb to receive local infiltration is determined after randomization of the knee allocated for adductor canal block in the same patient. The chosen knee is infiltrated by the orthopedic surgeon intraoperatively with a 150-ml mixture of 150 mg bupivacaine, 10 mg morphine, 30 mg ketorolac, and 0.5 mg epinephrine. The posterior capsule is infiltrated before placement of the prosthesis, and the periarticular and superficial soft tissues are infiltrated after the prosthesis is in place and before wound closure. Receives: Other: Pain scores (numerical rating scale at rest and motion); Other: Secondary outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Measured: Baseline (the day before surgery)
Pain score
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Measured: Hour 2 after surgery
Pain score
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Measured: Hour 8 after surgery
Pain score
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Measured: Hour 24 after surgery
Pain score
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Measured: Hour 36 after surgery
Pain score
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Measured: Hour 48 after surgery
Pain score
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Measured: Hour 60 after surgery
Pain score
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Measured: Hour 72 after surgery
Pain score
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Measured: The day of discharge
Pain score
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Measured: Month 3 after surgery
Secondary outcomes (33)
Knee range of motion
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Measured: Baseline (the day before surgery)
Knee range of motion
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Measured: Hour 24 after surgery
Knee range of motion
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Measured: Hour 72 after surgery
Knee range of motion
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Measured: the day of discharge
Knee range of motion
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Measured: Month 3 after surgery
Knee muscle power
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Measured: Baseline (the day before surgery)
Knee muscle power
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Measured: Hour 24 after surgery
Knee muscle power
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Measured: Hour 72 after surgery
Knee muscle power
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Measured: the day of discharge
Knee muscle power
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Measured: Month 3 after surgery
Six minute walk test
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Measured: Baseline (the day before surgery)
Six minute walk test
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Measured: Hour 24 after surgery
Six minute walk test
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Measured: Hour 72 after surgery
Six minute walk test
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Measured: the day of discharge
Six minute walk test
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Measured: Month 3 after surgery
Single leg stance test
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Measured: Baseline (the day before surgery)
Single leg stance test
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Measured: Hour 24 after surgery
Single leg stance test
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Measured: Hour 72 after surgery
Single leg stance test
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Measured: the day of discharge
Single leg stance test
To assess the stance ability and static postural and balance control on one leg without help either with eyes opened or closed before and after TKA surgery (assessed as seconds)
Measured: Month 3 after surgery
Functional questionnaires
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
Measured: Baseline (the day before surgery)
Functional questionnaires
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
Measured: the day of discharge
Functional questionnaires
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
Measured: Month 3 after surgery
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Measured: Baseline (the day before surgery)
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Measured: Hour 2 after surgery
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Measured: Hour 8 after surgery
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Measured: Hour 24 after surgery
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Measured: Hour 36 after surgery
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Measured: Hour 48 after surgery
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Measured: Hour 60 after surgery
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Measured: Hour 72 after surgery
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Measured: the day of discharge
Adverse events
Adverse events will be assessed with items including nausea, vomiting, somnolence, dizziness, urinary retention, skin itch, respiratory depression, and lower limb weakness, numbness, and allodynia
Measured: Month 3 after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2022
- Study start15 Oct 2018
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study is a prospective, single-centered, double-blinded, randomized controlled trial. We intend to compare two methods of postoperative analgesia, adductor canal block (ACB) and multimodal local infiltration (LI), simultaneously in patients receiving bilateral total knee arthroplasty. In other words, the patient will receive ACB in one knee and LI in the other knee after TKA surgery. Because this study is designed to apply these two methods respectively on either knee of the same patient, the relative analgesic efficacy can be assessed simultaneously. Like matched-pair designed study, this method can eliminate some confounding factors affecting pain scores.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Hsu Ma, MD, PhD, Study chair, Institutional Review Board, Taipei Veterans General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05439343
- Sponsor's protocol ID
- TPEVGH IRB No.: 2016-04-010C
- Status last verified
- Mar 2023
- First submitted
- 19 May 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Analgesic Efficacy and Functional Improvement of Adductor Canal Block and Multimodal Local Infiltration Analgesia for Patients After Bilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT05439343
- Acronym / sponsor ID
- TPEVGH IRB No.: 2016-04-010C
- Conditions
- Arthroplasty, Replacement, Knee, Analgesia, Rehabilitation
- Keywords
- Arthroplasty, Replacement, Knee, adductor canal block, Local infiltration, Regional analgesia, Pain, Postoperative, Rehabilitation, Muscle power
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 15 Oct 2018 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 30 Jun 2022 (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.
Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literatures. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay. By reducing hospital stay, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.
Detailed description
Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literature. Some patients choose to receive bilateral TKA simultaneously to avoid repetitive surgery and anesthesia, and are supposed to suffer more than those receiving unilateral TKA. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay and postoperative complications. By reducing the length of in-hospital stay and post-operative complication, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after bilateral simultaneous TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, muscle power in knee adduction/abduction movement, and time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study is a prospective, single-centered, double-blinded, randomized controlled trial. We intend to compare two methods of postoperative analgesia, adductor canal block (ACB) and multimodal local infiltration (LI), simultaneously in patients receiving bilateral total knee arthroplasty. In other words, the patient will receive ACB in one knee and LI in the other knee after TKA surgery. Because this study is designed to apply these two methods respectively on either knee of the same patient, the relative analgesic efficacy can be assessed simultaneously. Like matched-pair designed study, this method can eliminate some confounding factors affecting pain scores.
| Arm | Type | Receives |
|---|---|---|
| Adductor canal block | Experimental | Other: Pain scores (numerical rating scale at rest and motion), Other: Secondary outcomesAllocation of which limb is to receive adductor canal block is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, adductor canal block will be performed by an anesthesiologist. Under ultrasound guidance, the femoral artery and the saphenous nerve are identified in the middle one-third of the thigh, deep to the sartorious muscle in the adductor canal. The sartorious and adductor muscles form the roof and the floor of the canal, respectively. Following skin infiltration, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through a 3-inch, 23-gauge, short bevel block needle. |
| Local infiltration | Experimental | Other: Pain scores (numerical rating scale at rest and motion), Other: Secondary outcomesAllocation of the other limb to receive local infiltration is determined after randomization of the knee allocated for adductor canal block in the same patient. The chosen knee is infiltrated by the orthopedic surgeon intraoperatively with a 150-ml mixture of 150 mg bupivacaine, 10 mg morphine, 30 mg ketorolac, and 0.5 mg epinephrine. The posterior capsule is infiltrated before placement of the prosthesis, and the periarticular and superficial soft tissues are infiltrated after the prosthesis is in place and before wound closure. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients were eligible to enter the study if their age are between 20 to 90 years old and scheduled for bilateral TKA secondary to osteoarthritis.
Key exclusion criteria (1 listed)
- American Society of Anesthesiologists (ASA) physical status class IV-V, history of abnormal liver enzymes, hepatic failure, renal insufficiency, cardiac failure, organ transplant, neuropathic pain, history of stroke or major neurological deficit, coagulopathy, thrombocytopenia, sensory and motor disorders in lower limb, previous drug dependency, chronic use of opioids, allergy to local anesthetics and drug used in experiment, inability to walk independently, inability to comprehend pain assessment and patients refusing to have spinal anesthesia or enter this study.
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 |
|---|---|---|
| Pain scores (numerical rating scale at rest and motion)As the primary outcome of the present clinical study, pain scores will be assessed with numerical rating scale at both rest and motion on both knees. | Other | Adductor canal block, Local infiltration |
| Secondary outcomesBrief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale will be used as the questionnaires for functional assessment. Rehabilitation physiotherapy will be assessed with knee range of motion (both active and maximal passive), muscle power at abduction and adduction, single leg stance test, six-minute walk test for assessment of the functional recovery of knee joints. | Other | Adductor canal block, Local infiltration |
Primary outcome
Pain score
Time frame: Baseline (the day before surgery)
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Pain score
Time frame: Hour 2 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Pain score
Time frame: Hour 8 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Pain score
Time frame: Hour 24 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Pain score
Time frame: Hour 36 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Pain score
Time frame: Hour 48 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Pain score
Time frame: Hour 60 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Pain score
Time frame: Hour 72 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Pain score
Time frame: The day of discharge
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
Pain score
Time frame: Month 3 after surgery
Assess the pain intensity with numerical rating scale both at rest and motion in each knee. A 11 point (0-10) numerical rating scale defines 0 as no pain and 10 as the worst pain imaginable,
33 secondary outcomes
Knee range of motion
Time frame: Baseline (the day before surgery)
Knee range of motion
Time frame: Hour 24 after surgery
Knee range of motion
Time frame: Hour 72 after surgery
Knee range of motion
Time frame: the day of discharge
Knee range of motion
Time frame: Month 3 after surgery
Knee muscle power
Time frame: Baseline (the day before surgery)
Knee muscle power
Time frame: Hour 24 after surgery
Knee muscle power
Time frame: Hour 72 after surgery
Knee muscle power
Time frame: the day of discharge
Knee muscle power
Time frame: Month 3 after surgery
Six minute walk test
Time frame: Baseline (the day before surgery)
Six minute walk test
Time frame: Hour 24 after surgery
Six minute walk test
Time frame: Hour 72 after surgery
Six minute walk test
Time frame: the day of discharge
Six minute walk test
Time frame: Month 3 after surgery
Single leg stance test
Time frame: Baseline (the day before surgery)
Single leg stance test
Time frame: Hour 24 after surgery
Single leg stance test
Time frame: Hour 72 after surgery
Single leg stance test
Time frame: the day of discharge
Single leg stance test
Time frame: Month 3 after surgery
Functional questionnaires
Time frame: Baseline (the day before surgery)
Functional questionnaires
Time frame: the day of discharge
Functional questionnaires
Time frame: Month 3 after surgery
Adverse events
Time frame: Baseline (the day before surgery)
Adverse events
Time frame: Hour 2 after surgery
Adverse events
Time frame: Hour 8 after surgery
Adverse events
Time frame: Hour 24 after surgery
Adverse events
Time frame: Hour 36 after surgery
Adverse events
Time frame: Hour 48 after surgery
Adverse events
Time frame: Hour 60 after surgery
Adverse events
Time frame: Hour 72 after surgery
Adverse events
Time frame: the day of discharge
Adverse events
Time frame: Month 3 after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Individual participant dataSharing planned: No
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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.
Hsu Ma, MD, PhD study chair
Institutional Review Board, Taipei Veterans General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain scores (numerical rating scale at rest and motion) and Secondary outcomes in people with Arthroplasty, Replacement, Knee and Analgesia, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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: status not confirmed, as of the sponsor's last update on 10 Mar 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 Taiwan. 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?
Results are not available in the source record.
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?
Pain score (time frame: Baseline (the day before surgery)). The study lists 10 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 10 Mar 2023.