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

NCT05669898 | Unknown DMC

• 1 other identifier: TPEVGH IRB No.: 2018-08-007A
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Arthroplasty, Replacement, Knee; Pain, Postoperative; Multimodal Analgesia

Keywords

Arthroplasty, Replacement, Knee; Regional analgesia; multimodal analgesia; Rehabilitation; Recovery of Function

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (39)

• Rehabilitation physiotherapy: Knee flexion angle

  Baseline (day of admission)

• Rehabilitation physiotherapy: Knee flexion angle

  Hour 24 after surgery

• Rehabilitation physiotherapy: Knee flexion angle

  Hour 72 after surgery

• Rehabilitation physiotherapy: Knee flexion angle

  1 Day of discharge

• Rehabilitation physiotherapy: Knee flexion angle

  Month 3 after surgery

Study Arms (2)

Single-injection ACB combined with IV-PCA morphine

ACTIVE COMPARATOR

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.; Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale; Behavioral: Rehabilitation physiotherapy

Continuous adductor canal infusion combined with intravenous NSAID

ACTIVE COMPARATOR

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.; Other: Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale; Behavioral: Rehabilitation physiotherapy

Interventions

Pain scores (numerical rating scale at rest and motion): will be assessed with numerical rating scale at both rest and motion on both knees. BEHAVIORAL

Pain scores will be assessed with numerical rating scale at both rest and motion on both knees.

Continuous adductor canal infusion combined with intravenous NSAID; Single-injection ACB combined with IV-PCA morphine

Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale OTHER

For the functional assessment both before and after TKA surgery.

Continuous adductor canal infusion combined with intravenous NSAID; Single-injection ACB combined with IV-PCA morphine

Rehabilitation physiotherapy BEHAVIORAL

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.

Continuous adductor canal infusion combined with intravenous NSAID; Single-injection ACB combined with IV-PCA morphine

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Hsu Ma, MD, PhD

  Institutional Review Board, Taipei Veterans General Hospital

  STUDY CHAIR

Central Study Contacts

Chun-Sung Sung, MD, PhD

CONTACT

886-2-28757549; cssung@vghtpe.gov.tw

Fang-Yao Chiu, MD

CONTACT

886-9-76308308; fychiu@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: A two-arm parallel assignment involves two groups of participants receiving multimodal analgesia after unilateral total knee arthroplasty. One group receives a single-injection adductor canal block combined with intravenous morphine patient-controlled analgesia, and the other group receives continuous adductor canal infusion in combination with intermittent intravenous non-steroidal anti-inflammatory drug.

Study Record Dates

• First Submitted: May 23, 2022
• First Posted: January 3, 2023
• Study Start: May 21, 2019
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)