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

Primary Purpose

Anesthesia, Local, Pain, Postoperative

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Short-term ON-Q
Short-term ON-Q
Short-term ON-Q
Long-term ON-Q
Long-term ON-Q
Long-term ON-Q
Sponsored by
AdventHealth
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia, Local focused on measuring Total Knee Arthroplasty, Intra-articular Analgesia, Bupivacaine Hydrochloride

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Florida Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Short-term ON-Q

Long-term ON-Q

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

Change from Baseline Day of Surgery Pain Scores at 6 Weeks.
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.
Opioid and Analgesic Use
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.
Number of Participants Who Experience Common Opioid and Analgesic Side Effects
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.
Patient Range of Motion (degrees)
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.

Secondary Outcome Measures

Quality of Life - SF-12
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.
Quality of Life - EQ-5D-5L
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.

Full Information

First Posted
March 7, 2017
Last Updated
August 1, 2019
Sponsor
AdventHealth
Collaborators
Halyard Health
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1. Study Identification

Unique Protocol Identification Number
NCT03245359
Brief Title
Pain Management After TKA: Comparison of Short- and Long-term Nerve Blocks
Official Title
Pain Management After TKA: Comparison of Short- and Long-term Concurrent Saphenous (Adductor Canal) and Posterior Nerve Blocks Using the ON-Q Pump System
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
January 8, 2019 (Actual)
Study Completion Date
May 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AdventHealth
Collaborators
Halyard Health

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Local, Pain, Postoperative
Keywords
Total Knee Arthroplasty, Intra-articular Analgesia, Bupivacaine Hydrochloride

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Short-term ON-Q
Arm Type
Active Comparator
Arm Description
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)
Arm Title
Long-term ON-Q
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Short-term ON-Q
Intervention Description
single port, select-a-flow pump connected to saphenous nerve block catheter until medication in initial balls are depleted (usually 2-4 days)
Intervention Type
Device
Intervention Name(s)
Short-term ON-Q
Intervention Description
single port, fixed flow pump connected to posterior knee catheter until medication in initial balls are depleted (usually 2-4 days)
Intervention Type
Drug
Intervention Name(s)
Short-term ON-Q
Intervention Description
Bupivacaine 0.125%
Intervention Type
Device
Intervention Name(s)
Long-term ON-Q
Intervention Description
single port, select-a-flow pump connected to saphenous nerve block catheter until day 7 post-operative
Intervention Type
Device
Intervention Name(s)
Long-term ON-Q
Intervention Description
single port, fixed flow pump connected to posterior knee catheter until day 7 post-operative
Intervention Type
Drug
Intervention Name(s)
Long-term ON-Q
Intervention Description
Bupivacaine 0.125%
Primary Outcome Measure Information:
Title
Change from Baseline Day of Surgery Pain Scores at 6 Weeks.
Description
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.
Time Frame
This will be collected from day of surgery to 6-weeks postoperative
Title
Opioid and Analgesic Use
Description
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.
Time Frame
This will be collected daily from day of surgery through day 7 post-operative.
Title
Number of Participants Who Experience Common Opioid and Analgesic Side Effects
Description
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.
Time Frame
This will be collected daily from day of surgery through day 7 post-operative.
Title
Patient Range of Motion (degrees)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Quality of Life - SF-12
Description
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.
Time Frame
This assessment will be collected at 2- and 6-week follow-up office visits.
Title
Quality of Life - EQ-5D-5L
Description
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.
Time Frame
This assessment will be collected at 2- and 6-week follow-up office visits.
Other Pre-specified Outcome Measures:
Title
Number of Participants with Intraoperative Blood Loss (mL)
Description
Intraoperative blood loss in mL will be collected from patient records
Time Frame
Conclusion of Surgery
Title
Hemoglobin Laboratory Results (grams/deciliter)
Description
Hemoglobin levels will be collected from patient records
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).
Title
Hematocrit Laboratory Results (Percentage of Concentration)
Description
Hematocrit levels will be collected from patient records.
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).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
J. Dean Cole, M.D.
Organizational Affiliation
AdventHealth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32804
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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