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

NCT03245359 | Completed FDA Device

• 1 other identifier: 880424
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia, Local; Pain, Postoperative

Keywords

Total Knee Arthroplasty; Intra-articular Analgesia; Bupivacaine Hydrochloride

Outcome Measures

Primary Outcomes (4)

• 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.

  This will be collected from day of surgery to 6-weeks postoperative

• 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.

  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

  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)

  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 Outcomes (2)

• Quality of Life - SF-12

  This assessment will be collected at 2- and 6-week follow-up office visits.

• Quality of Life - EQ-5D-5L

  This assessment will be collected at 2- and 6-week follow-up office visits.

Other Outcomes (3)

• Number of Participants with Intraoperative Blood Loss (mL)

  Conclusion of Surgery

• Hemoglobin Laboratory Results (grams/deciliter)

  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)

  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).

Study Arms (2)

Short-term ON-Q

ACTIVE COMPARATOR

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; Drug: Short-term ON-Q

Long-term ON-Q

EXPERIMENTAL

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; Drug: Long-term ON-Q

Interventions

Short-term ON-Q DEVICE

single port, select-a-flow pump connected to saphenous nerve block catheter until medication in initial balls are depleted (usually 2-4 days)

Short-term ON-Q

Long-term ON-Q DEVICE

single port, select-a-flow pump connected to saphenous nerve block catheter until day 7 post-operative

Long-term ON-Q

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• AdventHealth: lead
• Halyard Health: collaborator

Study Sites (1)

Florida Hospital

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• J. Dean Cole, M.D.

  AdventHealth

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2017
• First Posted: August 10, 2017
• Study Start: September 28, 2017
• Primary Completion: January 8, 2019
• Study Completion: May 20, 2019
• Last Updated: August 2, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)