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NCT Number: NCT03245359

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Florida Hospital

Orlando, Florida, 32804, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Drug

Bupivacaine 0.125%

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

Drug

Bupivacaine 0.125%

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

Other outcomes

  1. Number of Participants with Intraoperative Blood Loss (mL)

    Time frame: Conclusion of Surgery

    Intraoperative blood loss in mL will be collected from patient records

  2. 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

  3. 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.

Sponsors and collaborators

Lead sponsor

AdventHealth

Other

Collaborators

  • Halyard Health

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 10, 2017
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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