Clinical trial NCT05669898: Continuous Adductor Canal Infusion vs. Single-injection Adductor Canal Block for Total Knee Arthroplasty
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Pain, Postoperative
Multimodal Analgesia
Keywords: Arthroplasty, Replacement, Knee
Regional analgesia
multimodal analgesia
Rehabilitation
Recovery of Function
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2023-01-03
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Pain scores at rest and motion
timeFrame: Baseline (day of admission)
measure: Change in Pain scores at rest and motion
timeFrame: Hour 2 after surgery
measure: Change in Pain scores at rest and motion
timeFrame: Hour 8 after surgery
measure: Change in Pain scores at rest and motion
timeFrame: Hour 24 after surgery
measure: Change in Pain scores at rest and motion
timeFrame: Hour 36 after surgery
measure: Change in Pain scores at rest and motion
timeFrame: Hour 48 after surgery
measure: Change in Pain scores at rest and motion
timeFrame: Hour 60 after surgery
measure: Change in Pain scores at rest and motion
timeFrame: Hour 72 after surgery
measure: Change in Pain scores at rest and motion
timeFrame: 1 day of discharge
measure: Change in Pain scores at rest and motion
timeFrame: Month 3 after surgery
Secondary outcomes:
measure: Rehabilitation physiotherapy: Knee flexion angle
timeFrame: Baseline (day of admission)
measure: Rehabilitation physiotherapy: Knee flexion angle
timeFrame: Hour 24 after surgery
measure: Rehabilitation physiotherapy: Knee flexion angle
timeFrame: Hour 72 after surgery
measure: Rehabilitation physiotherapy: Knee flexion angle
timeFrame: 1 Day of discharge
measure: Rehabilitation physiotherapy: Knee flexion angle
timeFrame: Month 3 after surgery
measure: Rehabilitation physiotherapy: knee muscle strength
timeFrame: Baseline (day of admission)
measure: Rehabilitation physiotherapy: knee muscle strength
timeFrame: Hour 24 after surgery
measure: Rehabilitation physiotherapy: knee muscle strength
timeFrame: Hour 72 after surgery
measure: Rehabilitation physiotherapy: knee muscle strength
timeFrame: 1 day of discharge
measure: Rehabilitation physiotherapy: knee muscle strength
timeFrame: Month 3 after surgery
measure: Rehabilitation physiotherapy: Six minute walk test
timeFrame: Baseline (day of admission)
measure: Rehabilitation physiotherapy: Six minute walk test
timeFrame: Hour 24 after surgery
measure: Rehabilitation physiotherapy: Six minute walk test
timeFrame: Hour 72 after surgery
measure: Rehabilitation physiotherapy: Six minute walk test
timeFrame: 1 date of discharge
measure: Rehabilitation physiotherapy: Six minute walk test
timeFrame: Month 3 after surgery
measure: Rehabilitation physiotherapy: Single leg stance test
timeFrame: Baseline (day of admission)
measure: Rehabilitation physiotherapy: Single leg stance test
timeFrame: Hour 24 after surgery
measure: Rehabilitation physiotherapy: Single leg stance test
timeFrame: Hour 72 after surgery
measure: Rehabilitation physiotherapy: Single leg stance test
timeFrame: 1 day of discharge
measure: Rehabilitation physiotherapy: Single leg stance test
timeFrame: Month 3 after surgery
measure: Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
timeFrame: Baseline (day of admission)
measure: Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
timeFrame: 1 day of discharge
measure: Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index
timeFrame: Month 3 after surgery
measure: Functional questionnaire: Brief pain inventory (BPI) short form
timeFrame: Baseline (day of admission)
measure: Functional questionnaire: Brief pain inventory (BPI) short form
timeFrame: 1 day of discharge
measure: Functional questionnaire: Brief pain inventory (BPI) short form
timeFrame: Month 3 after surgery
measure: Functional questionnaire: Lower extremity functional scale
timeFrame: Baseline (day of admission)
measure: Functional questionnaire: Lower extremity functional scale
timeFrame: 1 date of discharge
measure: Functional questionnaire: Lower extremity functional scale
timeFrame: Month 3 after surgery
measure: Adverse events
timeFrame: Baseline (day of admission)
measure: Adverse events
timeFrame: Hour 2 after surgery
measure: Adverse events
timeFrame: Hour 8 after surgery
measure: Adverse events
timeFrame: Hour 24 after surgery
measure: Adverse events
timeFrame: Hour 36 after surgery
measure: Adverse events
timeFrame: Hour 48 after surgery
measure: Adverse events
timeFrame: Hour 60 after surgery
measure: Adverse events
timeFrame: Hour 72 after surgery
measure: Adverse events
timeFrame: 1 day of discharge
measure: Adverse events
timeFrame: Month 3 after surgery
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
Study officials:
affiliation: Institutional Review Board, Taipei Veterans General Hospital
name: Hsu Ma, MD, PhD
role: STUDY_CHAIR
References: