Pain Management After TKA: Comparison of Short- and Long-term Nerve Blocks
| Status: | Recruiting |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/8/2017 |
| Start Date: | September 28, 2017 |
| End Date: | December 31, 2018 |
| Contact: | J. Dean Cole, M.D. |
| Email: | JDCole@FCCDocs.com |
| Phone: | 407-895-8890 |
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.
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.
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.
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.
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
We found this trial at
1
site
601 E Rollins St
Orlando, Florida 32803
Orlando, Florida 32803
(407) 303-5600
Principal Investigator: J. Dean Cole, MD
Phone: 407-303-9233
Florida Hospital Florida Hospital is one of the country
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