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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05669898
• Other study ID #: TPEVGH IRB No.: 2018-08-007A
• Status: Recruiting
• Phase: N/A
• Start date: May 21, 2019
• Est. completion date: June 30, 2023

Study information

• Verified date: March 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chun-Sung Sung, MD, PhD
• Phone: 886-2-28757549
• Email: cssung[@]vghtpe.gov.tw
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 30, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

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	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)
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rehabilitation physiotherapy: Six minute walk test	To assess the walk ability (6-minute walk distance) before and after surgery (meters)	Baseline (day of admission)
Secondary	Rehabilitation physiotherapy: Six minute walk test	To assess the walk ability (6-minute walk distance) before and after surgery (meters)	Hour 24 after surgery
Secondary	Rehabilitation physiotherapy: Six minute walk test	To assess the walk ability (6-minute walk distance) before and after surgery (meters)	Hour 72 after surgery
Secondary	Rehabilitation physiotherapy: Six minute walk test	To assess the walk ability (6-minute walk distance) before and after surgery (meters)	1 date of discharge
Secondary	Rehabilitation physiotherapy: Six minute walk test	To assess the walk ability (6-minute walk distance) before and after surgery (meters)	Month 3 after surgery
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index	For functional pain assessment	Baseline (day of admission)
Secondary	Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index	For functional pain assessment	1 day of discharge
Secondary	Functional questionnaire: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Osteoarthritis Index	For functional pain assessment	Month 3 after surgery
Secondary	Functional questionnaire: Brief pain inventory (BPI) short form	For functional pain assessment	Baseline (day of admission)
Secondary	Functional questionnaire: Brief pain inventory (BPI) short form	For functional pain assessment	1 day of discharge
Secondary	Functional questionnaire: Brief pain inventory (BPI) short form	For functional pain assessment	Month 3 after surgery
Secondary	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)
Secondary	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
Secondary	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
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 (day of admission)
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	1 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