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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
Pain scores will be assessed with numerical rating scale at both rest and motion on both knees.
For the functional assessment both before and after TKA surgery.
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.
Taipei Veterans General Hospital
Taipei, Taiwan
RECRUITINGChange 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Month 3 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 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
Time frame: 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
Time frame: Month 3 after surgery
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Time frame: Baseline (day of admission)
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Time frame: Hour 24 after surgery
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Time frame: Hour 72 after surgery
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Time frame: 1 date of discharge
Rehabilitation physiotherapy: Six minute walk test
To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Month 3 after surgery
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
For functional pain assessment
Time frame: Baseline (day of admission)
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
For functional pain assessment
Time frame: 1 day of discharge
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
For functional pain assessment
Time frame: Month 3 after surgery
Functional questionnaire: Brief pain inventory (BPI) short form
For functional pain assessment
Time frame: Baseline (day of admission)
Functional questionnaire: Brief pain inventory (BPI) short form
For functional pain assessment
Time frame: 1 day of discharge
Functional questionnaire: Brief pain inventory (BPI) short form
For functional pain assessment
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Month 3 after surgery