Adductor Canal Block and Multimodal Local Infiltration Analgesia in Patients Receiving Total Knee Arthroplasty

March 9, 2023 updated by: Taipei Veterans General Hospital, Taiwan

Comparison of Analgesic Efficacy and Functional Improvement of Adductor Canal Block and Multimodal Local Infiltration Analgesia for Patients After Bilateral Total Knee Arthroplasty

Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literatures. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay. By reducing hospital stay, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Total knee arthroplasty (TKA) is associated with moderate to severe pain after operation. There are twenty thousand patients undertaking TKA annually in Taiwan, and the average length of hospital stay is about seven to ten days. In contrast, the length of hospital stay is only three to six days in some literature. Some patients choose to receive bilateral TKA simultaneously to avoid repetitive surgery and anesthesia, and are supposed to suffer more than those receiving unilateral TKA. Adequate pain relief after surgery allows patients to mobilize earlier and easier and rehabilitate to reduce the length of hospital stay and postoperative complications. By reducing the length of in-hospital stay and post-operative complication, we can reduce medical expenditure of national health insurance. In addition, effective analgesia can reduce the occurrence of chronic post-surgical pain which would compromise life quality and produce socioeconomic problems. This study tries to find a better solution for postoperative analgesia of TKA for patients in Taiwan. The present clinical study compares the effect of adductor canal block and local infiltration on postoperative analgesia and functional activity after bilateral simultaneous TKA. To assess the outcome of both methods in the same patient, we can have more comparative result of pain score and functional parameters like range of motion of knee joint, muscle power in knee adduction/abduction movement, and time and ability to ambulate. Based on that, we try to find a better option for postoperative analgesia for patients receiving TKA in Taiwan.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients were eligible to enter the study if their age are between 20 to 90 years old and scheduled for bilateral TKA secondary to osteoarthritis.

Exclusion Criteria:

  • American Society of Anesthesiologists (ASA) physical status class IV-V, history of abnormal liver enzymes, hepatic failure, renal insufficiency, cardiac failure, organ transplant, neuropathic pain, history of stroke or major neurological deficit, coagulopathy, thrombocytopenia, sensory and motor disorders in lower limb, previous drug dependency, chronic use of opioids, allergy to local anesthetics and drug used in experiment, inability to walk independently, inability to comprehend pain assessment and patients refusing to have spinal anesthesia or enter this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Adductor canal block
Allocation of which limb is to receive adductor canal block 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.
Other: Pain scores (numerical rating scale at rest and motion)
As the primary outcome of the present clinical study, pain scores will be assessed with numerical rating scale at both rest and motion on both knees.
Other: Secondary outcomes
Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale will be used as the questionnaires for functional assessment. 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 knee joints.
Experimental: Local infiltration
Allocation of the other limb to receive local infiltration is determined after randomization of the knee allocated for adductor canal block in the same patient. The chosen knee is infiltrated by the orthopedic surgeon intraoperatively with a 150-ml mixture of 150 mg bupivacaine, 10 mg morphine, 30 mg ketorolac, and 0.5 mg epinephrine. The posterior capsule is infiltrated before placement of the prosthesis, and the periarticular and superficial soft tissues are infiltrated after the prosthesis is in place and before wound closure.
Other: Pain scores (numerical rating scale at rest and motion)
As the primary outcome of the present clinical study, pain scores will be assessed with numerical rating scale at both rest and motion on both knees.
Other: Secondary outcomes
Brief Pain Inventory (Short Form), WOMAC Osteoarthritis index, and Lower extremity functional scale will be used as the questionnaires for functional assessment. 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 knee joints.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain score
Time Frame: Baseline (the day before 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,
Baseline (the day before surgery)
Pain score
Time Frame: Hour 2 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,
Hour 2 after surgery
Pain score
Time Frame: Hour 8 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,
Hour 8 after surgery
Pain score
Time Frame: Hour 24 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,
Hour 24 after surgery
Pain score
Time Frame: Hour 36 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,
Hour 36 after surgery
Pain score
Time Frame: Hour 48 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,
Hour 48 after surgery
Pain score
Time Frame: Hour 60 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,
Hour 60 after surgery
Pain score
Time Frame: Hour 72 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,
Hour 72 after surgery
Pain score
Time Frame: The day of discharge
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,
The day of discharge
Pain score
Time Frame: 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,
Month 3 after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Knee range of motion
Time Frame: Baseline (the day before surgery)
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Baseline (the day before surgery)
Knee range of motion
Time Frame: Hour 24 after surgery
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Hour 24 after surgery
Knee range of motion
Time Frame: Hour 72 after surgery
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Hour 72 after surgery
Knee range of motion
Time Frame: the day of discharge
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
the day of discharge
Knee range of motion
Time Frame: Month 3 after surgery
Maximal range of motion at both continuous passive motion and active motion will be assessed with protractor (degrees)
Month 3 after surgery
Knee muscle power
Time Frame: Baseline (the day before surgery)
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Baseline (the day before surgery)
Knee muscle power
Time Frame: Hour 24 after surgery
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Hour 24 after surgery
Knee muscle power
Time Frame: Hour 72 after surgery
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Hour 72 after surgery
Knee muscle power
Time Frame: the day of discharge
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
the day of discharge
Knee muscle power
Time Frame: Month 3 after surgery
Both adduction and abduction muscle power on both knees will be assessed with Commander Echo Algometry (pounds)
Month 3 after surgery
Six minute walk test
Time Frame: Baseline (the day before surgery)
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Baseline (the day before surgery)
Six minute walk test
Time Frame: Hour 24 after surgery
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Hour 24 after surgery
Six minute walk test
Time Frame: Hour 72 after surgery
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Hour 72 after surgery
Six minute walk test
Time Frame: the day of discharge
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
the day of discharge
Six minute walk test
Time Frame: Month 3 after surgery
To assess the walk ability (6-minute walk distance) before and after TKA surgery (meters)
Month 3 after surgery
Single leg stance test
Time Frame: Baseline (the day before 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)
Baseline (the day before surgery)
Single leg stance test
Time Frame: Hour 24 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)
Hour 24 after surgery
Single leg stance test
Time Frame: Hour 72 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)
Hour 72 after surgery
Single leg stance test
Time Frame: the day of discharge
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)
the day of discharge
Single leg stance test
Time Frame: 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)
Month 3 after surgery
Functional questionnaires
Time Frame: Baseline (the day before surgery)
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
Baseline (the day before surgery)
Functional questionnaires
Time Frame: the day of discharge
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
the day of discharge
Functional questionnaires
Time Frame: Month 3 after surgery
Functional pain scale will be assessed with Western Ontario and McMaster Universities Osteoarthritis Index, Brief pain inventory (BPI) short form, and Lower extremity functional scale
Month 3 after surgery
Adverse events
Time Frame: Baseline (the day before 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
Baseline (the day before surgery)
Adverse events
Time Frame: Hour 2 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
Hour 2 after surgery
Adverse events
Time Frame: Hour 8 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
Hour 8 after surgery
Adverse events
Time Frame: Hour 24 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
Hour 24 after surgery
Adverse events
Time Frame: Hour 36 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
Hour 36 after surgery
Adverse events
Time Frame: Hour 48 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
Hour 48 after surgery
Adverse events
Time Frame: Hour 60 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
Hour 60 after surgery
Adverse events
Time Frame: Hour 72 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
Hour 72 after surgery
Adverse events
Time Frame: the day of discharge
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
the day of discharge
Adverse events
Time Frame: 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
Month 3 after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Taipei Veterans General Hospital, Taiwan

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Hsu Ma, MD, PhD, Institutional Review Board, Taipei Veterans General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 15, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 19, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 30, 2022

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 9, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TPEVGH IRB No.: 2016-04-010C

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

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