Continuous Adductor Canal Infusion vs. Single-injection Adductor Canal Block for Total Knee Arthroplasty

Multimodal Analgesia for Unilateral Total Knee Arthroplasty: Impact of Continuous Adductor Canal Infusion Combined With NSAID vs. Intravenous Morphine Patient-controlled Analgesia Combined With Single-injection Adductor Canal Block

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.

Study Overview

• Status: Recruiting
• Conditions: Pain, Postoperative; Arthroplasty, Replacement, Knee; Multimodal Analgesia
• Intervention / Treatment: Behavioral: Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees.; Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale; Behavioral: Rehabilitation physiotherapy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Sung Sung, MD, PhD; Phone Number: 320 886-2-28757549; Email: cssung@vghtpe.gov.tw
• Study Contact Backup: Name: Fang-Yao Chiu, MD; Phone Number: 886-9-76308308; Email: fychiu@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 11217
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Chun-Sung Sung, MD, PhD; Phone Number: 320 886-2-28757549; Email: cssung@vghtpe.gov.tw
    • Contact: Fang-Yao Chiu, MD; Phone Number: 886-9-76308308; Email: fychiu@vghtpe.gov.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

• Clinical diagnosis of knee osteoarthritis
• Must be aged between 20 to 90 years old
• Must be scheduled for unilateral total knee arthroplasty surgery
• Must agree to enroll into the clinical trial and have signed the written informed consent

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Single-injection ACB combined with IV-PCA morphine; 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.	Behavioral: Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees.; Pain scores will be assessed with numerical rating scale at both rest and motion on both knees.; Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale; For the functional assessment both before and after TKA surgery.; Behavioral: Rehabilitation physiotherapy; 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 both knees.
Active Comparator: Continuous adductor canal infusion combined with intravenous NSAID; 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.	Behavioral: Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees.; Pain scores will be assessed with numerical rating scale at both rest and motion on both knees.; Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale; For the functional assessment both before and after TKA surgery.; Behavioral: Rehabilitation physiotherapy; 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 both knees.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Pain scores at rest and motion	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 (day of admission)
Change in Pain scores at rest and motion	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
Change in Pain scores at rest and motion	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
Change in Pain scores at rest and motion	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
Change in Pain scores at rest and motion	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
Change in Pain scores at rest and motion	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
Change in Pain scores at rest and motion	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
Change in Pain scores at rest and motion	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
Change in Pain scores at rest and motion	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.	1 day of discharge
Change in Pain scores at rest and motion	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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
Rehabilitation physiotherapy: Knee flexion angle	Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)	Baseline (day of admission)
Rehabilitation physiotherapy: Knee flexion angle	Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)	Hour 24 after surgery
Rehabilitation physiotherapy: Knee flexion angle	Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)	Hour 72 after surgery
Rehabilitation physiotherapy: Knee flexion angle	Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)	1 Day of discharge
Rehabilitation physiotherapy: Knee flexion angle	Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)	Month 3 after surgery
Rehabilitation physiotherapy: knee muscle strength	Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester	Baseline (day of admission)
Rehabilitation physiotherapy: knee muscle strength	Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester	Hour 24 after surgery
Rehabilitation physiotherapy: knee muscle strength	Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester	Hour 72 after surgery
Rehabilitation physiotherapy: knee muscle strength	Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester	1 day of discharge
Rehabilitation physiotherapy: knee muscle strength	Muscle power of the surgical knee at abduction and adduction accessed by JTech Commander Echo Manual Muscle Tester	Month 3 after surgery
Rehabilitation physiotherapy: Six minute walk test	To assess the walk ability (6-minute walk distance) before and after surgery (meters)	Baseline (day of admission)
Rehabilitation physiotherapy: Six minute walk test	To assess the walk ability (6-minute walk distance) before and after surgery (meters)	Hour 24 after surgery
Rehabilitation physiotherapy: Six minute walk test	To assess the walk ability (6-minute walk distance) before and after surgery (meters)	Hour 72 after surgery
Rehabilitation physiotherapy: Six minute walk test	To assess the walk ability (6-minute walk distance) before and after surgery (meters)	1 date of discharge
Rehabilitation physiotherapy: Six minute walk test	To assess the walk ability (6-minute walk distance) before and after surgery (meters)	Month 3 after surgery
Rehabilitation physiotherapy: 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 (day of admission)
Rehabilitation physiotherapy: 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
Rehabilitation physiotherapy: 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
Rehabilitation physiotherapy: 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)	1 day of discharge
Rehabilitation physiotherapy: 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
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index	For functional pain assessment	Baseline (day of admission)
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index	For functional pain assessment	1 day of discharge
Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index	For functional pain assessment	Month 3 after surgery
Functional questionnaire: Brief pain inventory (BPI) short form	For functional pain assessment	Baseline (day of admission)
Functional questionnaire: Brief pain inventory (BPI) short form	For functional pain assessment	1 day of discharge
Functional questionnaire: Brief pain inventory (BPI) short form	For functional pain assessment	Month 3 after surgery
Functional questionnaire: Lower extremity functional scale	Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.	Baseline (day of admission)
Functional questionnaire: Lower extremity functional scale	Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.	1 date of discharge
Functional questionnaire: Lower extremity functional scale	Scoring scales from 0 to 80 with the maximum score being 80 and the lower score meaning the the greater disability.	Month 3 after surgery
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 (day of admission)
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	1 day of discharge

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Investigators: Study Chair: Hsu Ma, MD, PhD, Institutional Review Board, Taipei Veterans General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2019
• Primary Completion (Anticipated): May 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: May 23, 2022
• First Submitted That Met QC Criteria: December 30, 2022
• First Posted (Actual): January 3, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Rehabilitation; multimodal analgesia; Recovery of Function; Regional analgesia; Arthroplasty, Replacement, Knee
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: TPEVGH IRB No.: 2018-08-007A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No