Pain, Postoperative Clinical Trial
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | June 30, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years to 90 Years |
Eligibility | Inclusion Criteria - 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 Exclusion Criteria: - 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 - 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Taipei Veterans General Hospital | Taipei |
Lead Sponsor | Collaborator |
---|---|
Taipei Veterans General Hospital, Taiwan |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline (day of admission) | |
Primary | 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. | Hour 2 after surgery | |
Primary | 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. | Hour 8 after surgery | |
Primary | 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. | Hour 24 after surgery | |
Primary | 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. | Hour 36 after surgery | |
Primary | 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. | Hour 48 after surgery | |
Primary | 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. | Hour 60 after surgery | |
Primary | 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. | Hour 72 after surgery | |
Primary | 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. | 1 day of discharge | |
Primary | 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. | Month 3 after surgery | |
Secondary | Rehabilitation physiotherapy: Knee flexion angle | Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees) | Baseline (day of admission) | |
Secondary | Rehabilitation physiotherapy: Knee flexion angle | Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees) | Hour 24 after surgery | |
Secondary | Rehabilitation physiotherapy: Knee flexion angle | Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees) | Hour 72 after surgery | |
Secondary | Rehabilitation physiotherapy: Knee flexion angle | Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees) | 1 Day of discharge | |
Secondary | Rehabilitation physiotherapy: Knee flexion angle | Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees) | Month 3 after surgery | |
Secondary | Rehabilitation physiotherapy: knee muscle strength | Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester | Baseline (day of admission) | |
Secondary | Rehabilitation physiotherapy: knee muscle strength | Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester | Hour 24 after surgery | |
Secondary | Rehabilitation physiotherapy: knee muscle strength | Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester | Hour 72 after surgery | |
Secondary | Rehabilitation physiotherapy: knee muscle strength | Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester | 1 day of discharge | |
Secondary | Rehabilitation physiotherapy: knee muscle strength | Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester | Month 3 after surgery | |
Secondary | Rehabilitation physiotherapy: Six minute walk test | To assess the walk ability (6-minute walk distance) before and after surgery (meters) | Baseline (day of admission) | |
Secondary | Rehabilitation physiotherapy: Six minute walk test | To assess the walk ability (6-minute walk distance) before and after surgery (meters) | Hour 24 after surgery | |
Secondary | Rehabilitation physiotherapy: Six minute walk test | To assess the walk ability (6-minute walk distance) before and after surgery (meters) | Hour 72 after surgery | |
Secondary | Rehabilitation physiotherapy: Six minute walk test | To assess the walk ability (6-minute walk distance) before and after surgery (meters) | 1 date of discharge | |
Secondary | Rehabilitation physiotherapy: Six minute walk test | To assess the walk ability (6-minute walk distance) before and after surgery (meters) | Month 3 after surgery | |
Secondary | 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) | Baseline (day of admission) | |
Secondary | 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) | Hour 24 after surgery | |
Secondary | 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) | Hour 72 after surgery | |
Secondary | 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) | 1 day of discharge | |
Secondary | 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) | Month 3 after surgery | |
Secondary | Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index | For functional pain assessment | Baseline (day of admission) | |
Secondary | Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index | For functional pain assessment | 1 day of discharge | |
Secondary | Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index | For functional pain assessment | Month 3 after surgery | |
Secondary | Functional questionnaire: Brief pain inventory (BPI) short form | For functional pain assessment | Baseline (day of admission) | |
Secondary | Functional questionnaire: Brief pain inventory (BPI) short form | For functional pain assessment | 1 day of discharge | |
Secondary | Functional questionnaire: Brief pain inventory (BPI) short form | For functional pain assessment | Month 3 after surgery | |
Secondary | 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. | Baseline (day of admission) | |
Secondary | 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. | 1 date of discharge | |
Secondary | 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. | Month 3 after surgery | |
Secondary | 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 | Baseline (day of admission) | |
Secondary | 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 | Hour 2 after surgery | |
Secondary | 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 | Hour 8 after surgery | |
Secondary | 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 | Hour 24 after surgery | |
Secondary | 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 | Hour 36 after surgery | |
Secondary | 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 | Hour 48 after surgery | |
Secondary | 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 | Hour 60 after surgery | |
Secondary | 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 | Hour 72 after surgery | |
Secondary | 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 | 1 day of discharge | |
Secondary | 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 | Month 3 after surgery |
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