Pain Management After TKA: Comparison of Short- and Long-term Nerve Blocks

August 1, 2019 updated by: AdventHealth

Pain Management After TKA: Comparison of Short- and Long-term Concurrent Saphenous (Adductor Canal) and Posterior Nerve Blocks Using the ON-Q Pump System

The purpose of this study is to determine if there is any significant difference between using a short-term ON-Q nerve block (which is applied prior to surgery and maintained in place until the medication in the initial balls have been fully used, usually 2-4 days) in comparison to a long-term ON-Q nerve block (which is applied prior to surgery and maintained in place up to seven days after surgery). This study will analyze patient reported levels of pain, range of motion, and narcotic use, as well as investigate whether blood loss, blood thinners, and hemoglobin/hematocrit blood levels influence patient pain levels.

This study will compare patient-reported pain, range of motion and narcotic use in total knee arthroplasty patients who receive the short-term and long-term combination nerve block (saphenous and posterior of the adductor canal and wide-field posterior knee.

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

Post-operative pain remains one of the patient's greatest concerns after Total Knee Arthroplasty (TKA). Insufficient pain control can delay mobilization and inhibit rehabilitation efforts. Multimodal analgesia, including peripheral nerve block, is recommended for pain relief, and reaching an effective level of pain management, while minimizing opioid side effects, is vital to a patient's recovery and satisfaction of care delivered. The ON-Q pain relief system continually infuses local analgesia for effective pain relief.

This is a prospective, randomized control trial designed to compare the effects of using the short-term and long-term combination ON-Q nerve blocks in connection with TKA surgery. The ON-Q nerve block and pump system provides slowly infused, continuous delivery of a local anesthetic to the surgical site and nerves. The use of concurrent saphenous and posterior knee nerve blocks with the ON-Q system has been adopted as standard procedure at our institute. The study does not involve an alteration to the typical procedures currently being employed. Ultrasound will ensure the accuracy of catheter placement by a regional anesthesiologist.

All consecutive TKA patients who meet study criteria will be recruited for enrollment in the study prior to surgery. Pre-operatively, patients will be asked to complete health questionnaires, assessments to measure reported pain levels and location, and range of motion. Home medications will be reviewed, and hemoglobin/hematocrit blood levels will be recorded. Patients randomized to the long-term group will receive education on how to connect the ON-Q ball/pump to the catheter using a demonstration set to show understanding of the skill. Patients in the long-term group will also receive a 750mL ON-Q ball/pump filled with bupivacaine 0.125% for the select-a-flow saphenous catheter nerve block and a 400mL ON-Q ball/pump filled with bupivacaine 0.125% for the posterior fixed rate catheter nerve block to enable the nerve blocks to last up to the 7 days of treatment.

Post-operatively, blood loss, inpatient hemoglobin/hematocrit levels, pain medications consumed and side effects, range of motion by Physical Therapy, and pain assessments will be recorded. After discharge, patients will receive daily phone calls up to day 7 post-op to collect reported pain scores, pain medications consumed and side effects, signs/symptoms of catheter site infection, and physical therapy or activity for that day. This information, as well as health questionnaires, will also be collected from both treatment groups at the 2-week and 6-week follow-up office visits.

Data will be analyzed at the conclusion of the study.

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.
50

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
    • Florida
      • Orlando, Florida, United States, 32804
        • Florida 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 18 years
  • Able to provide informed consent
  • Undergoing elective total knee arthroplasty
  • Able to tolerate both short- and long-term ON-Q therapy

Exclusion Criteria:

  • Unable to provide informed consent
  • History of dementia or mental instability
  • Pregnancy

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: 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: Short-term ON-Q
Single port, select-a-flow pump and ON-Q 750mL ball filled with bupivacaine 0.125% saphenous (adductor canal) nerve block and single port, fixed flow pump and 400mL ON-Q ball with bupivacaine 0.125% wide field posterior knee block to provide analgesia from surgery until medication has been depleted (typically 2-4 days)
Device: Short-term ON-Q
single port, select-a-flow pump connected to saphenous nerve block catheter until medication in initial balls are depleted (usually 2-4 days)
Device: Short-term ON-Q
single port, fixed flow pump connected to posterior knee catheter until medication in initial balls are depleted (usually 2-4 days)
Drug: Short-term ON-Q
Bupivacaine 0.125%
EXPERIMENTAL: Long-term ON-Q
Single port, select-a-flow pump and two 750mL ON-Q balls filled with bupivacaine 0.125% saphenous (adductor canal) nerve block and single port, fixed flow pump and two 400mL ON-Q ball with bupivacaine 0.125% wide field posterior knee block to provide analgesia from surgery up to 7 days post-operative. The second ball for each location will be provided pre-operatively, along with patient education for connection.
Device: Long-term ON-Q
single port, select-a-flow pump connected to saphenous nerve block catheter until day 7 post-operative
Device: Long-term ON-Q
single port, fixed flow pump connected to posterior knee catheter until day 7 post-operative
Drug: Long-term ON-Q
Bupivacaine 0.125%

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
Change from Baseline Day of Surgery Pain Scores at 6 Weeks.
Time Frame: This will be collected from day of surgery to 6-weeks postoperative
This study will assess patient reported pain, as determined by results of the Numeric Pain Rating Scale of 0-10 while knee is at rest and with active bending movement to determine if there is a difference between the short- and long-term groups.
This will be collected from day of surgery to 6-weeks postoperative
Opioid and Analgesic Use
Time Frame: This will be collected daily from day of surgery through day 7 post-operative.
Concomitant pain medications consumed while still using the ON-Q nerve block system will be documented, in order to identify reduction/increases in patient's opioid consumption trends.
This will be collected daily from day of surgery through day 7 post-operative.
Number of Participants Who Experience Common Opioid and Analgesic Side Effects
Time Frame: This will be collected daily from day of surgery through day 7 post-operative.
Concomitant pain medication side effects that are commonly experienced while still using the ON-Q nerve block system will be documented, including nausea, constipation or rash.
This will be collected daily from day of surgery through day 7 post-operative.
Patient Range of Motion (degrees)
Time Frame: This will be completed at all inpatient physical therapy sessions on day 1 and 2 post-operative and follow-up office visits at 2 and 6 weeks post-operative.
Range of motion measured in degrees will be collected. This will be measured by PI and/or Physical Therapy assessments and used to compare whether there is a difference in the participants range of motion between short- and long-term groups.
This will be completed at all inpatient physical therapy sessions on day 1 and 2 post-operative and follow-up office visits at 2 and 6 weeks post-operative.

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
Quality of Life - SF-12
Time Frame: This assessment will be collected at 2- and 6-week follow-up office visits.
Evaluate the patient quality of life through SF-12 assessment score to assess if there is a trending difference between short- and long-term groups.
This assessment will be collected at 2- and 6-week follow-up office visits.
Quality of Life - EQ-5D-5L
Time Frame: This assessment will be collected at 2- and 6-week follow-up office visits.
Evaluate the patient quality of life through EQ-5D-5L assessment score to assess if there is a trending difference between short- and long-term groups.
This assessment will be collected at 2- and 6-week follow-up office visits.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants with Intraoperative Blood Loss (mL)
Time Frame: Conclusion of Surgery
Intraoperative blood loss in mL will be collected from patient records
Conclusion of Surgery
Hemoglobin Laboratory Results (grams/deciliter)
Time Frame: Hemoglobin and hematocrit laboratory results will be collected from the patient's pre-operative testing laboratory results (within 30 days before surgery) and from post-operative inpatient laboratory results (within 48 hours post-operative).
Hemoglobin levels will be collected from patient records
Hemoglobin and hematocrit laboratory results will be collected from the patient's pre-operative testing laboratory results (within 30 days before surgery) and from post-operative inpatient laboratory results (within 48 hours post-operative).
Hematocrit Laboratory Results (Percentage of Concentration)
Time Frame: Hemoglobin and hematocrit laboratory results will be collected from the patient's pre-operative testing laboratory results (within 30 days before surgery) and from post-operative inpatient laboratory results (within 48 hours post-operative).
Hematocrit levels will be collected from patient records.
Hemoglobin and hematocrit laboratory results will be collected from the patient's pre-operative testing laboratory results (within 30 days before surgery) and from post-operative inpatient laboratory results (within 48 hours post-operative).

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.
AdventHealth

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Halyard Health

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.
  • Principal Investigator: J. Dean Cole, M.D., AdventHealth

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.
September 28, 2017

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.
January 8, 2019

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.
May 20, 2019

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).
March 7, 2017

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.
August 7, 2017

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.
August 10, 2017

Study Record Updates

Last Update Posted (ACTUAL)

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.
August 2, 2019

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.
August 1, 2019

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.
August 1, 2019

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.
  • 880424

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

Yes

product manufactured in and exported from the U.S.

No

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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