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

NCT ID: NCT05669898

Last Updated: 2023-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-21
• Study Completion Date: 2023-06-30

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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

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

Intervention Type: OTHER

For the functional assessment both before and after TKA surgery.

Rehabilitation physiotherapy

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: BEHAVIORAL

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

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

Intervention Type: OTHER

For the functional assessment both before and after TKA surgery.

Rehabilitation physiotherapy

Intervention Type: 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.

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.

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

Intervention Type: BEHAVIORAL

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

For the functional assessment both before and after TKA surgery.

Intervention Type: OTHER

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hsu Ma, MD, PhD

Role: STUDY_CHAIR

Institutional Review Board, Taipei Veterans General Hospital

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Chun-Sung Sung, MD, PhD

Role: CONTACT

cssung@vghtpe.gov.tw

886-2-28757549 ext. 320

Fang-Yao Chiu, MD

Role: CONTACT

fychiu@vghtpe.gov.tw

886-9-76308308

Facility Contacts

Chun-Sung Sung, MD, PhD

Role: primary

cssung@vghtpe.gov.tw

886-2-28757549 ext. 320

Fang-Yao Chiu, MD

Role: backup

fychiu@vghtpe.gov.tw

886-9-76308308

Other Identifiers

TPEVGH IRB No.: 2018-08-007A

Identifier Type: -

Identifier Source: org_study_id