Arthroplasty, Replacement, KneeNCT05669898
Continuous Adductor Canal Infusion vs. Single-injection Adductor Canal Block for Total Knee Arthroplasty
A study testing Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees., Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale and Rehabilitation physiotherapy in people with Arthroplasty, Replacement, Knee and Pain, Postoperative, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Multimodal analgesia (MMA) has been endorsed to improve postoperative analgesia and functional activity after surgery, and integrating regional analgesia to reduce the consumption of opioid has also been used in postoperative pain management. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Pain, Postoperative, Multimodal Analgesia
- What is being tested?
- Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees., Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale and Rehabilitation physiotherapy
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 21 May 2019to 30 Jun 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
- Clinical diagnosis of knee osteoarthritis
- Must be aged between 20 to 90 years old
- Must be scheduled for unilateral total knee arthroplasty surgery
- Must agree to enroll into the clinical trial and have signed the written informed consent
Who cannot join
- American Society of Anesthesiologists physical status class IV-V
- Elevated liver enzymes or liver failure
- Renal dysfunction (serum creatinine level ≥ 1.5 mg/dL)
- Cardiac failure
- Organ transplantation recipient
- Stroke
Show all 17Show fewer
- Major neurological deficit with lower extremity muscle weakness
- Sensory and motor disorders in lower limb
- Coagulopathy or thrombocytopenia
- Previous drug dependency
- Patients who used illicit drugs within six months
- Chronic use of opioids
- Allergy to local anesthetics and drug used in experiment
- Inability to walk independently
- Inability to comprehend pain assessment
- Refusal for implanting a continuous peripheral nerve catheter
- Refusal for enrolling in study
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei Veterans General Hospital
Taipei, 11217
Chun-Sung Sung, MD, PhD, 886-2-28757549 ext. 320, cssung@vghtpe.gov.tw
Fang-Yao Chiu, MD, 886-9-76308308, fychiu@vghtpe.gov.tw
About this study
Official title: Multimodal Analgesia for Unilateral Total Knee Arthroplasty: Impact of Continuous Adductor Canal Infusion Combined With NSAID vs. Intravenous Morphine Patient-controlled Analgesia Combined With Single-injection Adductor Canal Block
Multimodal analgesia (MMA) has been endorsed to improve postoperative analgesia and functional activity after surgery, and integrating regional analgesia to reduce the consumption of opioid has also been used in postoperative pain management. The investigator try to find a better combination of MMA for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan, therefore the effect of single-injection and continuous infusion of peripheral nerve block is compared in patient undergoing unilateral TKA. The investigators hypothesize that continuous adductor canal infusion is as effective as single-injection adductor canal block for postoperative pain relief under intravenous PCA after TKA surgery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.
Read the detailed description
The study compares the effect of two multimodal analgesia protocols, the one integrating IVPCA morphine with single-injection adductor canal block and the other integrating continuous adductor canal infusion with timely administered intravenous tenoxicam, on postoperative analgesia and functional activity after TKA. To assess the outcome of both modalities, The investigators can have more comparative result of pain score and other functional parameters like range of motion of knee joint and muscle strength. Based on that, the investigators try to find a better multimodal analgesic approach for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan. The investigators hypothesize that multimodal analgesia using continuous adductor canal infusion and intravenous tenoxicam are as effective as another modality using IVPCA and single-injection adductor canal block for postoperative pain relief after TKA surgery. However, continuous adductor canal infusion integrated with intravenous tenoxicam might reduce the occurrence of opioid-related side effect and enhance the functional recovery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.
- Being tested
- Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees., Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale, Rehabilitation physiotherapy
- Keywords
- Arthroplasty, Replacement, Knee, Regional analgesia, multimodal analgesia, Rehabilitation, Recovery of Function
- Medical subject headings
- 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): will be assessed with numerical rating scale at both rest and motion on both knees.Behavioural
Pain scores will be assessed with numerical rating scale at both rest and motion on both knees.
Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scaleOther
For the functional assessment both before and after TKA surgery.
Rehabilitation physiotherapyBehavioural
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 both knees.
| Study group | Role | What they receive |
|---|---|---|
| Single-injection ACB combined with IV-PCA morphine | Active comparator | Allocation of which participant is to receive single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia (IV-morphine PCA) 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. Finally, the IV-morphine PCA will be connected to the intravenous catheter of the patient for postoperative pain management. Receives: Behavioral: Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees.; Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale; Behavioral: Rehabilitation physiotherapy |
| Continuous adductor canal infusion combined with intravenous NSAID | Active comparator | Allocation of which participant is to receive continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug (NSAID) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, a peripheral nerve catheter will be implanted into adductor canal 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 the peripheral nerve catheter is implanted, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through the catheter. Intravenous tenoxicam 20 mg for a total amount of 3 doses at 24-hour interval after surgery will be added in the postoperative pain management. Receives: Behavioral: Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees.; Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale; Behavioral: Rehabilitation physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain scores at rest and motion
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 (day of admission)
Change in Pain scores at rest and motion
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
Change in Pain scores at rest and motion
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
Change in Pain scores at rest and motion
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
Change in Pain scores at rest and motion
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
Change in Pain scores at rest and motion
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
Change in Pain scores at rest and motion
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
Change in Pain scores at rest and motion
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
Change in Pain scores at rest and motion
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: 1 day of discharge
Change in Pain scores at rest and motion
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 (39)
Rehabilitation physiotherapy: Knee flexion angle
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Measured: Baseline (day of admission)
Rehabilitation physiotherapy: Knee flexion angle
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Measured: Hour 24 after surgery
Rehabilitation physiotherapy: Knee flexion angle
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Measured: Hour 72 after surgery
Rehabilitation physiotherapy: Knee flexion angle
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Measured: 1 Day of discharge
Rehabilitation physiotherapy: Knee flexion angle
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Measured: Month 3 after surgery
Rehabilitation physiotherapy: knee muscle strength
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Measured: Baseline (day of admission)
Rehabilitation physiotherapy: knee muscle strength
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Measured: Hour 24 after surgery
Rehabilitation physiotherapy: knee muscle strength
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Measured: Hour 72 after surgery
Rehabilitation physiotherapy: knee muscle strength
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Measured: 1 day of discharge
Rehabilitation physiotherapy: knee muscle strength
Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Measured: Month 3 after surgery
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Measured: Baseline (day of admission)
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Measured: Hour 24 after surgery
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Measured: Hour 72 after surgery
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Measured: 1 date of discharge
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Measured: Month 3 after surgery
Rehabilitation physiotherapy: 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 (day of admission)
Rehabilitation physiotherapy: 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
Rehabilitation physiotherapy: 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
Rehabilitation physiotherapy: 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: 1 day of discharge
Rehabilitation physiotherapy: 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 questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
For functional pain assessment
Measured: Baseline (day of admission)
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
For functional pain assessment
Measured: 1 day of discharge
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
For functional pain assessment
Measured: Month 3 after surgery
Functional questionnaire: Brief pain inventory (BPI) short form
For functional pain assessment
Measured: Baseline (day of admission)
Functional questionnaire: Brief pain inventory (BPI) short form
For functional pain assessment
Measured: 1 day of discharge
Functional questionnaire: Brief pain inventory (BPI) short form
For functional pain assessment
Measured: Month 3 after surgery
Functional questionnaire: Lower extremity functional scale
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
Measured: Baseline (day of admission)
Functional questionnaire: Lower extremity functional scale
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
Measured: 1 date of discharge
Functional questionnaire: Lower extremity functional scale
Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
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 (day of admission)
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: 1 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 posted3 Jan 2023
- Study start21 May 2019
- Primary completion31 May 2023 (estimated)
- Study completion30 Jun 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
- Parallel groups
- Model description
- A two-arm parallel assignment involves two groups of participants receiving multimodal analgesia after unilateral total knee arthroplasty. One group receives a single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia, and the other group receives continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
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
- NCT05669898
- Sponsor's protocol ID
- TPEVGH IRB No.: 2018-08-007A
- Status last verified
- Mar 2023
- First submitted
- 23 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
- Multimodal Analgesia for Unilateral Total Knee Arthroplasty: Impact of Continuous Adductor Canal Infusion Combined With NSAID vs. Intravenous Morphine Patient-controlled Analgesia Combined With Single-injection Adductor Canal Block
- ClinicalTrials.gov ID
- NCT05669898
- Acronym / sponsor ID
- TPEVGH IRB No.: 2018-08-007A
- Keywords
- Arthroplasty, Replacement, Knee, Regional analgesia, multimodal analgesia, Rehabilitation, Recovery of Function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 21 May 2019 (actual)
- Primary completion
- 31 May 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 3 Jan 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.
Multimodal analgesia (MMA) has been endorsed to improve postoperative analgesia and functional activity after surgery, and integrating regional analgesia to reduce the consumption of opioid has also been used in postoperative pain management. The investigator try to find a better combination of MMA for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan, therefore the effect of single-injection and continuous infusion of peripheral nerve block is compared in patient undergoing unilateral TKA. The investigators hypothesize that continuous adductor canal infusion is as effective as single-injection adductor canal block for postoperative pain relief under intravenous PCA after TKA surgery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.
Detailed description
The study compares the effect of two multimodal analgesia protocols, the one integrating IVPCA morphine with single-injection adductor canal block and the other integrating continuous adductor canal infusion with timely administered intravenous tenoxicam, on postoperative analgesia and functional activity after TKA. To assess the outcome of both modalities, The investigators can have more comparative result of pain score and other functional parameters like range of motion of knee joint and muscle strength. Based on that, the investigators try to find a better multimodal analgesic approach for postoperative analgesia and functional recovery for patients receiving TKA in Taiwan. The investigators hypothesize that multimodal analgesia using continuous adductor canal infusion and intravenous tenoxicam are as effective as another modality using IVPCA and single-injection adductor canal block for postoperative pain relief after TKA surgery. However, continuous adductor canal infusion integrated with intravenous tenoxicam might reduce the occurrence of opioid-related side effect and enhance the functional recovery. Based on that, the investigators conduct this prospective, randomized controlled trial to examine our hypothesis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A two-arm parallel assignment involves two groups of participants receiving multimodal analgesia after unilateral total knee arthroplasty. One group receives a single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia, and the other group receives continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug.
| Arm | Type | Receives |
|---|---|---|
| Single-injection ACB combined with IV-PCA morphine | Active comparator | Behavioral: Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees., Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale, Behavioral: Rehabilitation physiotherapyAllocation of which participant is to receive single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia (IV-morphine PCA) 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. Finally, the IV-morphine PCA will be connected to the intravenous catheter of the patient for postoperative pain management. |
| Continuous adductor canal infusion combined with intravenous NSAID | Active comparator | Behavioral: Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees., Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale, Behavioral: Rehabilitation physiotherapyAllocation of which participant is to receive continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug (NSAID) is determined by randomization, using a computer-generated random sequence and opaque sealed envelopes. After completion of the TKA surgery and surgical suturing, a peripheral nerve catheter will be implanted into adductor canal 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 the peripheral nerve catheter is implanted, 20 mL of 0.25% bupivacaine with 1:400000 epinephrine is injected through the catheter. Intravenous tenoxicam 20 mg for a total amount of 3 doses at 24-hour interval after surgery will be added in the postoperative pain management. |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Clinical diagnosis of knee osteoarthritis
- Must be aged between 20 to 90 years old
- Must be scheduled for unilateral total knee arthroplasty surgery
- Must agree to enroll into the clinical trial and have signed the written informed consent
Key exclusion criteria (17 listed)
- American Society of Anesthesiologists physical status class IV-V
- Elevated liver enzymes or liver failure
- Renal dysfunction (serum creatinine level ≥ 1.5 mg/dL)
- Cardiac failure
- Organ transplantation recipient
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): will be assessed with numerical rating scale at both rest and motion on both knees.Pain scores will be assessed with numerical rating scale at both rest and motion on both knees. | Behavioural | Continuous adductor canal infusion combined with intravenous NSAID, Single-injection ACB combined with IV-PCA morphine |
| Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scaleFor the functional assessment both before and after TKA surgery. | Other | Continuous adductor canal infusion combined with intravenous NSAID, Single-injection ACB combined with IV-PCA morphine |
| Rehabilitation physiotherapyRehabilitation 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 both knees. | Behavioural | Continuous adductor canal infusion combined with intravenous NSAID, Single-injection ACB combined with IV-PCA morphine |
Primary outcome
Change in Pain scores at rest and motion
Time frame: Baseline (day of admission)
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.
Change in Pain scores at rest and motion
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.
Change in Pain scores at rest and motion
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.
Change in Pain scores at rest and motion
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.
Change in Pain scores at rest and motion
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.
Change in Pain scores at rest and motion
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.
Change in Pain scores at rest and motion
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.
Change in Pain scores at rest and motion
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.
Change in Pain scores at rest and motion
Time frame: 1 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.
Change in Pain scores at rest and motion
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.
39 secondary outcomes
Rehabilitation physiotherapy: Knee flexion angle
Time frame: Baseline (day of admission)
Rehabilitation physiotherapy: Knee flexion angle
Time frame: Hour 24 after surgery
Rehabilitation physiotherapy: Knee flexion angle
Time frame: Hour 72 after surgery
Rehabilitation physiotherapy: Knee flexion angle
Time frame: 1 Day of discharge
Rehabilitation physiotherapy: Knee flexion angle
Time frame: Month 3 after surgery
Rehabilitation physiotherapy: knee muscle strength
Time frame: Baseline (day of admission)
Rehabilitation physiotherapy: knee muscle strength
Time frame: Hour 24 after surgery
Rehabilitation physiotherapy: knee muscle strength
Time frame: Hour 72 after surgery
Rehabilitation physiotherapy: knee muscle strength
Time frame: 1 day of discharge
Rehabilitation physiotherapy: knee muscle strength
Time frame: Month 3 after surgery
Rehabilitation physiotherapy: Six minute walk test
Time frame: Baseline (day of admission)
Rehabilitation physiotherapy: Six minute walk test
Time frame: Hour 24 after surgery
Rehabilitation physiotherapy: Six minute walk test
Time frame: Hour 72 after surgery
Rehabilitation physiotherapy: Six minute walk test
Time frame: 1 date of discharge
Rehabilitation physiotherapy: Six minute walk test
Time frame: Month 3 after surgery
Rehabilitation physiotherapy: Single leg stance test
Time frame: Baseline (day of admission)
Rehabilitation physiotherapy: Single leg stance test
Time frame: Hour 24 after surgery
Rehabilitation physiotherapy: Single leg stance test
Time frame: Hour 72 after surgery
Rehabilitation physiotherapy: Single leg stance test
Time frame: 1 day of discharge
Rehabilitation physiotherapy: Single leg stance test
Time frame: Month 3 after surgery
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
Time frame: Baseline (day of admission)
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
Time frame: 1 day of discharge
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
Time frame: Month 3 after surgery
Functional questionnaire: Brief pain inventory (BPI) short form
Time frame: Baseline (day of admission)
Functional questionnaire: Brief pain inventory (BPI) short form
Time frame: 1 day of discharge
Functional questionnaire: Brief pain inventory (BPI) short form
Time frame: Month 3 after surgery
Functional questionnaire: Lower extremity functional scale
Time frame: Baseline (day of admission)
Functional questionnaire: Lower extremity functional scale
Time frame: 1 date of discharge
Functional questionnaire: Lower extremity functional scale
Time frame: Month 3 after surgery
Adverse events
Time frame: Baseline (day of admission)
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: 1 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): will be assessed with numerical rating scale at both rest and motion on both knees., Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale and Rehabilitation physiotherapy in people with Arthroplasty, Replacement, Knee and Pain, Postoperative, 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 4 inclusion and 17 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?
Contact Chun-Sung Sung, MD, PhD (886-2-28757549 ext. 320, cssung@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain scores at rest and motion (time frame: Baseline (day of admission)). 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.