Continuous Adductor Canal Infusion vs. Single-injection Adductor Canal Block for Total Knee Arthroplasty
- Conditions
- Multimodal AnalgesiaArthroplasty, Replacement, KneePain, Postoperative
- Interventions
- Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scaleBehavioral: Rehabilitation physiotherapy
- Registration Number
- NCT05669898
- Lead Sponsor
- Taipei Veterans General Hospital, Taiwan
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 80
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Continuous adductor canal infusion combined with intravenous NSAID Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale 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. Single-injection ACB combined with IV-PCA morphine Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale 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. Single-injection ACB combined with IV-PCA morphine Rehabilitation physiotherapy 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. Continuous adductor canal infusion combined with intravenous NSAID Rehabilitation physiotherapy 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.
- Primary Outcome Measures
Name Time Method Change in Pain scores at rest and motion 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.
- Secondary Outcome Measures
Name Time Method Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index Month 3 after surgery For functional pain assessment
Rehabilitation physiotherapy: Knee flexion angle Month 3 after surgery Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Rehabilitation physiotherapy: knee muscle strength Month 3 after surgery Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester
Functional questionnaire: Brief pain inventory (BPI) short form Month 3 after surgery For functional pain assessment
Adverse events Month 3 after surgery 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
Rehabilitation physiotherapy: Six minute walk test Month 3 after surgery To assess the walk ability (6-minute walk distance) before and after surgery (meters)
Rehabilitation physiotherapy: Single leg stance test Month 3 after surgery 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)
Functional questionnaire: Lower extremity functional scale Month 3 after surgery Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.
Trial Locations
- Locations (1)
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan