Continuous Adductor Canal Block (CACB) vs. Combined Spinal Epidural (CSE) in Total Knee Arthroplasty

April 14, 2016 updated by: Rush University Medical Center

Purpose: Compare continuous adductor canal block (CACB) to Combined Spinal Epidural (CSE) for total knee arthroplasty in terms of mobility, post-operative pain, and analgesic use.

Hypothesis: CACB will provide better mobility than CSE post operatively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Purpose: Compare continuous adductor canal block (CACB) to Combined Spinal Epidural (CSE) for total knee arthroplasty in terms of mobility, post-operative pain, and analgesic use.

Hypothesis: CACB will provide better mobility than CSE post operatively.

Background/Scientific Review:

Total knee arthroplasty (TKA) is associated with varying degrees of pain post operatively ranging from mild to severe despite the use of comprehensive multimodal analgesic regimens1. Optimizing pain relief is vital for functional recovery after total knee arthroplasty2. Peripheral nerve blocks have been commonly used to improve pain relief and reduce opioid requirements. The addition of nerve blocks involving the femoral nerve have been shown to provide superior pain control3 and shortened hospital stay compared to epidural or intravenous patient controlled analgesia alone1. However, femoral nerve blocks can result in quadriceps weakness leading to functional impairment and an increased risk of falling post operatively4. Unlike Femoral Nerve Blocks (FNB), adductor canal blocks (ACB) are predominantly sensory blocks which preserve quadriceps muscle strength and ambulation ability better than FNBs, while providing equivalent pain relief5-9.

Recent randomized studies have also shown ACB to be superior to placebo in the setting of spinal and general intraoperative anesthesia in terms of ambulation, pain control, and opioid consumption10-12. In a recent retrospective cohort study, the addition of ACB to local infiltration analgesia (LIA) was associated with further improvement in early ambulation benchmarks and a higher rate of home discharge compared with only LIA9. While CACB and CSE are used as part of routine care at Rush University Medical Center and around the country, there have been no studies directly comparing CACB to CSE.

Study Design: Department funded, single center, prospective, randomized, parallel outcome based clinical trial. 300 subjects scheduled to undergo primary unilateral TKA will be randomized to receive CSE, CACB + General, or CACB + Spinal as per routine care. Subjects will be enrolled for no more than 6 weeks.

Power Analysis: Sample size calculations were based on the primary aim, of CACB plus Spinal anesthesia versus standard care (combined spinal epidural, CSE) improving ambulation distance at postoperative day 1 (POD1). Based on results from a pilot study we found that the CSE group had at POD1 a mean distance traveled of 159 feet with a standard deviation (SD) of 111 feet, while the CACB + Spinal anesthesia subjects walked over twice the distance on average with a similar SD.

To be conservative we expect both the CACB + Spinal anesthesia and CACB + General Anesthesia groups to walk at least 35% farther on average, or at least equal to CSE group.

Based on a one-way, 3-level AVOVA with the primary contrast of CABC + Spinal versus CSE at a 35% greater ambulation difference, for 90% power, with α of 5%, requires a sample size of 84 subjects per group. Increasing the sample size to 100 will provide for a 16% dropout rate. Total of 300 patients.

Treatment Groups:

  1. General Intraoperative Anesthesia with standard post-operative Continuous Adductor Canal Block (0.2% ropivacaine running at 6-8mL/hr) with standard post-operative analgesics.
  2. Spinal Intraoperative Anesthesia with standard post-operative Continuous Adductor Canal Block (0.2% ropivacaine running at 6-8mL/hr) with standard post-operative analgesics.
  3. Spinal Intraoperative Anesthesia with standard Epidural (0.1% bupivacaine with fentanyl 5 mcg/mL running at 6mL/hr with 1mL q15 bolus) with standard post-operative analgesics.

Demographics/Patient Specifics: Age, Sex, ASA score, Weight, Height, Operative Time, BMI, Walker, Cane, Unassisted Ambulation

Risks/Benefits:

Combined spinal epidural anesthesia, general anesthesia, and continuous adductor canal blocks are part of routine anesthesia care at Rush University Medical Center and around the country. Post-operative analgesia regiments are standard of care.

Risks of general anesthesia include sore throat, nausea/vomiting, potential tooth damage, vocal cord injury, mental confusion, awareness, stroke, death. Risks of regional anesthesia (spinal) include bleeding (spinal hematoma), infection (meningitis), nerve damage, headache, hypotension, difficulty urinating, and seizures. There is no difference between epidural catheter and adductor canal catheter in terms of risks, other than the adductor canal catheter carries no risk of headache. These risks are present regardless of the study since either general or spinal anesthesia is used in all total knee arthroplasty procedures.

The only risk involved in participating in the study is the potential for breach of confidentiality and/or privacy. Below is a description of the procedure for maintaining confidentiality. There is no direct benefit to the participants in this study.

Procedures for Maintaining Confidentiality A breach of confidentiality and/or privacy is a risk of this study. To prevent this, all collected data will be stored electronically in password-protected files to protect patient identity and information. All information will be collected and reviewed by the research team only. Data will be maintained on a password-protected computer that will be accessible only to the study team. No patient identifiers will be maintained in the database.

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.
157

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

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Any patient scheduled for a primary unilateral TKA.

Exclusion Criteria:

  • Partial knee replacement,
  • chronic opioid use,
  • history of alcohol or drug abuse,
  • preexisting neuropathy in operative limb,
  • allergy to local anesthetics,
  • ASA Class >3,
  • patients who decline to participate,
  • BMI >40,
  • sleep apnea.

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: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

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.
ACTIVE_COMPARATOR: Combined Spinal Epidural
Spinal Intraoperative Anesthesia with standard Epidural (0.1% bupivacaine with fentanyl 5 mcg/mL running at 6mL/hr with 1mL q15 bolus) with standard post-operative analgesics.
Procedure: Epidural
Epidural (0.1% bupivacaine with fentanyl 5 mcg/mL running at 6mL/hr with 1mL q15 bolus)
Procedure: Spinal
Spinal Intraoperative Anesthesia
ACTIVE_COMPARATOR: General+Continuous Adductor Canal Block
General Intraoperative Anesthesia with standard post-operative Continuous Adductor Canal Block (0.2% ropivacaine running at 6-8mL/hr) with standard post-operative analgesics.
Procedure: Continuous Adductor Canal Block
Continuous Adductor Canal Block (0.2% ropivacaine running at 6-8mL/hr)
Procedure: General
General Intraoperative Anesthesia
ACTIVE_COMPARATOR: Spinal+Continuous Adductor Canal Block
Spinal Intraoperative Anesthesia with standard post-operative Continuous Adductor Canal Block (0.2% ropivacaine running at 6-8mL/hr) with standard post-operative analgesics.
Procedure: Spinal
Spinal Intraoperative Anesthesia
Procedure: Continuous Adductor Canal Block
Continuous Adductor Canal Block (0.2% ropivacaine running at 6-8mL/hr)

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
Ambulation Distance in feet
Time Frame: daily after surgery until discharge from hospital, expected average up to 5 days
Patient ambulation distance will be measured daily after surgery until discharge from hospital
daily after surgery until discharge from hospital, expected average up to 5 days

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
Straight Leg Raise
Time Frame: daily after surgery until discharge from hospital, expected average up to 5 days
Patient's ability to perform straight leg raise daily after surgery until discharge from hospital.
daily after surgery until discharge from hospital, expected average up to 5 days
Quadriceps strength
Time Frame: daily after surgery until discharge from hospital, expected average up to 5 days
Quadriceps strength evaluated using a standard non-invasive handheld dynamometer once pre-operatively and daily after surgery until discharged from hospital.
daily after surgery until discharge from hospital, expected average up to 5 days
Pain as measured by numeric pain score
Time Frame: daily after surgery until discharge from hospital, expected average up to 5 days
Post-operative numeric pain scores during rest and with activity during daily inpatient physical therapy sessions until discharge from hospital
daily after surgery until discharge from hospital, expected average up to 5 days
Post-operative inpatient opioid consumption (morphine equivalents)
Time Frame: daily after surgery until discharge from hospital, expected average up to 5 days
Post-operative inpatient opioid consumption (morphine equivalents) measured daily after surgery until discharge from hospital.
daily after surgery until discharge from hospital, expected average up to 5 days
Surgery Complications and Adverse Events during inpatient stay
Time Frame: daily after surgery until discahrge from hospital, expected average up to 5 days

Surgery Complications and Adverse Events during inpatient stay

  1. Respiratory depression
  2. Sedation
  3. Nausea
  4. Emesis
  5. Motor Blockade
  6. Pruritus
  7. Urinary Retention
  8. Hypotension
  9. Numbness
  10. Falls
  11. DVT or PE
  12. Catheter Site Infection
  13. Block Success
daily after surgery until discahrge from hospital, expected average up to 5 days

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.
Rush University Medical Center

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

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.
January 1, 2015

Primary Completion (ACTUAL)

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 1, 2016

Study Completion (ACTUAL)

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 1, 2016

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).
April 6, 2015

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.
April 8, 2015

First Posted (ESTIMATE)

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.
April 14, 2015

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.
April 15, 2016

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.
April 14, 2016

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.
April 1, 2016

More Information

Terms related to this study

Keywords

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.
  • 14090501

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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