Clinical trial NCT05439343: Adductor Canal Block and Multimodal Local Infiltration Analgesia in Patients Receiving Total Knee Arthroplasty
Official title: Comparison of Analgesic Efficacy and Functional Improvement of Adductor Canal Block and Multimodal Local Infiltration Analgesia for Patients After Bilateral Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Analgesia
Rehabilitation
Keywords: Arthroplasty, Replacement, Knee
adductor canal block
Local infiltration
Regional analgesia
Pain, Postoperative
Rehabilitation
Muscle power
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2022-06-30
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This study is a prospective, single-centered, double-blinded, randomized controlled trial. We intend to compare two methods of postoperative analgesia, adductor canal block (ACB) and multimodal local infiltration (LI), simultaneously in patients receiving bilateral total knee arthroplasty. In other words, the patient will receive ACB in one knee and LI in the other knee after TKA surgery. Because this study is designed to apply these two methods respectively on either knee of the same patient, the relative analgesic efficacy can be assessed simultaneously. Like matched-pair designed study, this method can eliminate some confounding factors affecting pain scores.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Pain score
timeFrame: Baseline (the day before surgery)
measure: Pain score
timeFrame: Hour 2 after surgery
measure: Pain score
timeFrame: Hour 8 after surgery
measure: Pain score
timeFrame: Hour 24 after surgery
measure: Pain score
timeFrame: Hour 36 after surgery
measure: Pain score
timeFrame: Hour 48 after surgery
measure: Pain score
timeFrame: Hour 60 after surgery
measure: Pain score
timeFrame: Hour 72 after surgery
measure: Pain score
timeFrame: The day of discharge
measure: Pain score
timeFrame: Month 3 after surgery
Secondary outcomes:
measure: Knee range of motion
timeFrame: Baseline (the day before surgery)
measure: Knee range of motion
timeFrame: Hour 24 after surgery
measure: Knee range of motion
timeFrame: Hour 72 after surgery
measure: Knee range of motion
timeFrame: the day of discharge
measure: Knee range of motion
timeFrame: Month 3 after surgery
measure: Knee muscle power
timeFrame: Baseline (the day before surgery)
measure: Knee muscle power
timeFrame: Hour 24 after surgery
measure: Knee muscle power
timeFrame: Hour 72 after surgery
measure: Knee muscle power
timeFrame: the day of discharge
measure: Knee muscle power
timeFrame: Month 3 after surgery
measure: Six minute walk test
timeFrame: Baseline (the day before surgery)
measure: Six minute walk test
timeFrame: Hour 24 after surgery
measure: Six minute walk test
timeFrame: Hour 72 after surgery
measure: Six minute walk test
timeFrame: the day of discharge
measure: Six minute walk test
timeFrame: Month 3 after surgery
measure: Single leg stance test
timeFrame: Baseline (the day before surgery)
measure: Single leg stance test
timeFrame: Hour 24 after surgery
measure: Single leg stance test
timeFrame: Hour 72 after surgery
measure: Single leg stance test
timeFrame: the day of discharge
measure: Single leg stance test
timeFrame: Month 3 after surgery
measure: Functional questionnaires
timeFrame: Baseline (the day before surgery)
measure: Functional questionnaires
timeFrame: the day of discharge
measure: Functional questionnaires
timeFrame: Month 3 after surgery
measure: Adverse events
timeFrame: Baseline (the day before surgery)
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: the 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: