Adductor Canal Block and Multimodal Local Infiltration Analgesia in Patients Receiving Total Knee Arthroplasty

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05439343
• Other study ID #: TPEVGH IRB No.: 2016-04-010C
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 15, 2018
• Est. completion date: March 31, 2023

Study information

• Verified date: March 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 64
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Analgesia
• Arthroplasty, Replacement, Knee
• Rehabilitation

Intervention

Other:
• Pain scores (numerical rating scale at rest and motion)
As the primary outcome of the present clinical study, pain scores will be assessed with numerical rating scale at both rest and motion on both knees.
• Secondary outcomes
Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale will be used as the questionnaires for functional assessment. Rehabilitation physiotherapy will be assessed with knee range of motion (both active and maximal passive), muscle power at abduction and adduction, single leg stance test, six-minute walk test for assessment of the functional recovery of knee joints.

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	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,	Baseline (the day before surgery)
Primary	Pain score	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,	Hour 2 after surgery
Primary	Pain score	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,	Hour 8 after surgery
Primary	Pain score	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,	Hour 24 after surgery
Primary	Pain score	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,	Hour 36 after surgery
Primary	Pain score	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,	Hour 48 after surgery
Primary	Pain score	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,	Hour 60 after surgery
Primary	Pain score	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,	Hour 72 after surgery
Primary	Pain score	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,	The day of discharge
Primary	Pain score	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,	Month 3 after surgery
Secondary	Knee range of motion	Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)	Baseline (the day before surgery)
Secondary	Knee range of motion	Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)	Hour 24 after surgery
Secondary	Knee range of motion	Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)	Hour 72 after surgery
Secondary	Knee range of motion	Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)	the day of discharge
Secondary	Knee range of motion	Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)	Month 3 after surgery
Secondary	Knee muscle power	Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)	Baseline (the day before surgery)
Secondary	Knee muscle power	Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)	Hour 24 after surgery
Secondary	Knee muscle power	Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)	Hour 72 after surgery
Secondary	Knee muscle power	Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)	the day of discharge
Secondary	Knee muscle power	Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)	Month 3 after surgery
Secondary	Six minute walk test	To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)	Baseline (the day before surgery)
Secondary	Six minute walk test	To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)	Hour 24 after surgery
Secondary	Six minute walk test	To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)	Hour 72 after surgery
Secondary	Six minute walk test	To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)	the day of discharge
Secondary	Six minute walk test	To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)	Month 3 after surgery
Secondary	Single leg stance test	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)	Baseline (the day before surgery)
Secondary	Single leg stance test	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)	Hour 24 after surgery
Secondary	Single leg stance test	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)	Hour 72 after surgery
Secondary	Single leg stance test	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)	the day of discharge
Secondary	Single leg stance test	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)	Month 3 after surgery
Secondary	Functional questionnaires	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	Baseline (the day before surgery)
Secondary	Functional questionnaires	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	the day of discharge
Secondary	Functional questionnaires	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	Month 3 after surgery
Secondary	Adverse events	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	Baseline (the day before surgery)
Secondary	Adverse events	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	Hour 2 after surgery
Secondary	Adverse events	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	Hour 8 after surgery
Secondary	Adverse events	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	Hour 24 after surgery
Secondary	Adverse events	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	Hour 36 after surgery
Secondary	Adverse events	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	Hour 48 after surgery
Secondary	Adverse events	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	Hour 60 after surgery
Secondary	Adverse events	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	Hour 72 after surgery
Secondary	Adverse events	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	the day of discharge
Secondary	Adverse events	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	Month 3 after surgery