Adductor Canal Block and Multimodal Local Infiltration Analgesia in Patients Receiving Total Knee Arthroplasty
- Conditions
- Arthroplasty, Replacement, KneeAnalgesiaRehabilitation
- Interventions
- Other: Pain scores (numerical rating scale at rest and motion)Other: Secondary outcomes
- Registration Number
- NCT05439343
- Lead Sponsor
- Taipei Veterans General Hospital, Taiwan
- Brief Summary
Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literatures. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay. By reducing hospital stay, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.
- Detailed Description
Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literature. Some patients choose to receive bilateral TKA simultaneously to avoid repetitive surgery and anesthesia, and are supposed to suffer more than those receiving unilateral TKA. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay and postoperative complications. By reducing the length of in-hospital stay and post-operative complication, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after bilateral simultaneous TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, muscle power in knee adduction/abduction movement, and time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 64
- Patients were eligible to enter the study if their age are between 20 to 90 years old and scheduled for bilateral TKA secondary to osteoarthritis.
- American Society of Anesthesiologists (ASA) physical status class IV-V, history of abnormal liver enzymes, hepatic failure, renal insufficiency, cardiac failure, organ transplant, neuropathic pain, history of stroke or major neurological deficit, coagulopathy, thrombocytopenia, sensory and motor disorders in lower limb, previous drug dependency, chronic use of opioids, allergy to local anesthetics and drug used in experiment, inability to walk independently, inability to comprehend pain assessment and patients refusing to have spinal anesthesia or enter this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Adductor canal block Pain scores (numerical rating scale at rest and motion) Allocation of which limb is to receive adductor canal block 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. Adductor canal block Secondary outcomes Allocation of which limb is to receive adductor canal block 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. Local infiltration Secondary outcomes Allocation of the other limb to receive local infiltration is determined after randomization of the knee allocated for adductor canal block in the same patient. The chosen knee is infiltrated by the orthopedic surgeon intraoperatively with a 150-ml mixture of 150 mg bupivacaine, 10 mg morphine, 30 mg ketorolac, and 0.5 mg epinephrine. The posterior capsule is infiltrated before placement of the prosthesis, and the periarticular and superficial soft tissues are infiltrated after the prosthesis is in place and before wound closure. Local infiltration Pain scores (numerical rating scale at rest and motion) Allocation of the other limb to receive local infiltration is determined after randomization of the knee allocated for adductor canal block in the same patient. The chosen knee is infiltrated by the orthopedic surgeon intraoperatively with a 150-ml mixture of 150 mg bupivacaine, 10 mg morphine, 30 mg ketorolac, and 0.5 mg epinephrine. The posterior capsule is infiltrated before placement of the prosthesis, and the periarticular and superficial soft tissues are infiltrated after the prosthesis is in place and before wound closure.
- Primary Outcome Measures
Name Time Method Pain score 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 Knee range of motion Month 3 after surgery Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Six minute walk test Month 3 after surgery To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
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 questionnaires Month 3 after surgery Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
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
Knee muscle power Month 3 after surgery Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Trial Locations
- Locations (1)
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan