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

Not Applicable

Recruiting

• Conditions: Multimodal Analgesia; Arthroplasty, Replacement, Knee; Pain, Postoperative

• Registration Number: NCT05669898
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

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.

Study Timeline

• Study Start: 2019-05-21
• Study First Submitted: 2022-05-23
• Study First Submitted QC: 2022-12-30
• Study First Posted: 2023-01-03
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-09
• Last Update Posted: 2023-03-10
• Primary Completion: 2023-05-31
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in Pain scores at rest and motion	Month 3 after surgery	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan