Anesthesia, LocalNCT03245359
Pain Management After TKA: Comparison of Short- and Long-term Nerve Blocks
A study testing Short-term ON-Q and Long-term ON-Q in people with Anesthesia, Local and Pain, Postoperative, run by AdventHealth at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Local, Pain, Postoperative
- What is being tested?
- Short-term ON-Q and Long-term ON-Q
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2017to 20 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Unable to provide informed consent
- History of dementia or mental instability
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Anesthesia, Local, Pain, Postoperative
- Being tested
- Short-term ON-Q, Long-term ON-Q
- Keywords
- Total Knee Arthroplasty, Intra-articular Analgesia, Bupivacaine Hydrochloride
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short-term ON-QDevice
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-QDevice
single port, fixed flow pump connected to posterior knee catheter until medication in initial balls are depleted (usually 2-4 days)
Short-term ON-QDrug
Bupivacaine 0.125%
Long-term ON-QDevice
single port, select-a-flow pump connected to saphenous nerve block catheter until day 7 post-operative
Long-term ON-QDevice
single port, fixed flow pump connected to posterior knee catheter until day 7 post-operative
Long-term ON-QDrug
Bupivacaine 0.125%
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Device: Long-term ON-Q; Drug: Long-term ON-Q |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: This assessment will be collected at 2- and 6-week follow-up office visits.
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.
Measured: This assessment will be collected at 2- and 6-week follow-up office visits.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start28 Sep 2017
- Primary completion8 Jan 2019
- Study completion20 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia, LocalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Collaborators
- Halyard Health
- Responsible party
- Sponsor
- Investigators
- J. Dean Cole, M.D., Principal investigator, AdventHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245359
- Sponsor's protocol ID
- 880424
- Status last verified
- Aug 2019
- First submitted
- 7 Mar 2017
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03245359
- Acronym / sponsor ID
- 880424
- Conditions
- Anesthesia, Local, Pain, Postoperative
- Keywords
- Total Knee Arthroplasty, Intra-articular Analgesia, Bupivacaine Hydrochloride
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Collaborators
- Halyard Health
- Study start
- 28 Sep 2017 (actual)
- Primary completion
- 8 Jan 2019 (actual)
- Study completion
- 20 May 2019 (actual)
- First posted
- 10 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short-term ON-Q | Active comparator | Device: Short-term ON-Q, Drug: Short-term ON-QSingle 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) |
| Long-term ON-Q | Experimental | Device: Long-term ON-Q, Drug: Long-term ON-QSingle 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- History of dementia or mental instability
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Short-term ON-Qsingle 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 |
| Short-term ON-Qsingle port, fixed flow pump connected to posterior knee catheter until medication in initial balls are depleted (usually 2-4 days) | Device | Short-term ON-Q |
| Short-term ON-QBupivacaine 0.125% | Drug | Short-term ON-Q |
| Long-term ON-Qsingle port, select-a-flow pump connected to saphenous nerve block catheter until day 7 post-operative | Device | Long-term ON-Q |
| Long-term ON-Qsingle port, fixed flow pump connected to posterior knee catheter until day 7 post-operative | Device | Long-term ON-Q |
| Long-term ON-QBupivacaine 0.125% | Drug | Long-term ON-Q |
Primary outcome
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.
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.
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.
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.
2 secondary outcomes
Quality of Life - SF-12
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Dean Cole, M.D. principal investigator
AdventHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Short-term ON-Q and Long-term ON-Q in people with Anesthesia, Local and Pain, Postoperative, run by AdventHealth at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2019.