Arthroplasty, Replacement, Knee, Multimodal Analgesia, Pain, Postoperative
Conditions
Keywords
Arthroplasty, Replacement, Knee, Regional analgesia, multimodal analgesia, Rehabilitation, Recovery of Function
Brief 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. 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.
Interventions
BEHAVIORALPain 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.
OTHERBrief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale
For the functional assessment both before and after TKA surgery.
BEHAVIORALRehabilitation physiotherapy
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.
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pain scores at rest and motion | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rehabilitation physiotherapy: knee muscle strength | Baseline (day of admission) | Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester |
| Rehabilitation physiotherapy: Six minute walk test | Baseline (day of admission) | To assess the walk ability (6-minute walk distance) before and after surgery (meters) |
| Rehabilitation physiotherapy: Single leg stance test | Baseline (day of admission) | 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) |
| Rehabilitation physiotherapy: Knee flexion angle | Baseline (day of admission) | Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees) |
| Functional questionnaire: Brief pain inventory (BPI) short form | Baseline (day of admission) | For functional pain assessment |
| Functional questionnaire: Lower extremity functional scale | Baseline (day of admission) | Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability. |
| Adverse events | Baseline (day of admission) | 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 |
| Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index | Baseline (day of admission) | For functional pain assessment |
Countries
Taiwan
Contacts
Primary ContactChun-Sung Sung, MD, PhD
Backup ContactFang-Yao Chiu, MD
Outcome results
None listed