Ankle strength after PPB or IPACK after TA

JRCT ID: jRCT1041230135

Registered date:18/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Total Knee Arthroplasty (TKA)
• Date of first enrollment: 18/01/2024
• Target sample size: 90
• Study type: Interventional

Intervention(s)

1. Perform various peripheral nerve blocks after induction of general anesthesia in the operating room. (Blinded for patients)
2. General anesthesia is performed by rapid induction with fentanyl and propofol followed by airway clearance. Propofol and fentanyl are used intraoperatively to maintain general anesthesia. Dosage is optimized for the patient's size and age.
3. For adductor canal block, administer 10 mL of 0.25% levobupivacaine.
4. A single injection of 15 mL of 0.25% levobupivacaine is then given as an orbital plexus block or IPACK block.
5. The ultrasound system will be a Sonimage MX1-alfa (Konika-Minolta Japan, Tokyo, Japan).
6. Peripheral nerve blocks are performed with a dedicated nerve block needle (Ultraplex 360, B. Braun, Melsungen, Germany). 100 mm block needles are used.

Outcome(s)

• Primary Outcome: Maximam Voluntary Isometric Contraction (MVIC) of ankle joint motion: dorsiflexion and plantar flexion of the ankle joint: preoperative, 6 24 hours postoperative

Secondary Outcome

1. Patient background: age, gender, height, weight, ASA Status
2. Preoperative complications and history
3. NRS score at rest at 1, 6, 10, and 24 hours postoperatively and during knee flexion rehabilitation
4. knee joint maximum range of motion (ROM) during rehabilitation on postoperative days 1-3
5. additional analgesic requirement at 72 hours postoperatively
6. successful upright raising (SLR) test at 1, 6, 24, and 72 hours postoperatively
7. frequency of postoperative side effects, including postoperative nausea/vomiting, falls, and pruritus
8. Maximam Voluntary Isometric Contraction (MVIC) of ankle joint motion: dorsiflexion and plantar flexion of the ankle joint: preoperative, 1, and 24 hours postoperative

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1.Patients undergoing scheduled TKA at Sogo Daioikai Hospital
2.Causal diseases leading to surgery are limited to osteoarthritis of the knee, rheumatoid knee, and related diseases.
3.Age at the time of consent is 20 years or older.
4.Written consent for participation has been obtained from the patient

Exclude criteria

1. Patients without the capacity to consent
2. Patients scheduled to undergo bilateral TKA in one surgery
3. Under 20 years old
4. Patients with allergies to the local anesthetic used (levobupivacaine)
5. Patients with American Society of Anesthesiologist (ASA) physical status over 3 (not including 3)
6. Patients who are regular users of narcotics, including medical narcotics, regardless of the disease.
7. Severe diabetic patients with marked diabetic paresthesia
8. Patients with neurological disorders
9. Patients with infection at the site of block needle puncture
10. Patients with platelet count under 500000/mcl
11. Pregnant, lactating, or possibly pregnant women
12. Other patients for whom peripheral nerve block is not indicated at the time of this surgery
13. Patients deemed by the treating physician to be ineligible for participation in this study

Related Information

• Primary Sponsor: Sakai Norihiro
• Secondary Sponsor: Michino Tomohiro