Osteoarthritis, KneeNCT02166632
Postoperative Pain Control Results Using Periarticular Versus Intra-capsular Injection of Bupivacaine Liposome Injectable Suspension in Total Knee Arthroplasty
A study testing Intracapsular Injection and Periarticular Injection in people with Osteoarthritis, Knee, run by Broward Health at 1 site in United States.
Trial summary
The purpose of this study is to determine quantitative and qualitative differences in post-operative pain relief for patients undergoing primary total knee arthroplasty (TKA) who receive administration of a newly approved, long acting local anesthetic branded as ExparelTM (bupivacaine liposome injectable suspension)… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Intracapsular Injection and Periarticular Injection
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Feb 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be over the age of 18
- Patients must have a preoperative diagnosis of osteoarthritis of the knee requiring total knee arthroplasty
Who cannot join
- Allergy to ExparelTM or certain other local anesthetic agents
- Pregnant females or females who think they may become pregnant
- Markedly abnormal kidney function or renal disease
- History of substance abuse
- History of chronic pain requiring medication
- Had a previous total knee arthroplasty on the same knee which is being replaced (revision total knee arthroplasty)
- Had a previous partial knee arthroplasty, such as a unicompartmental knee arthroplasty on the same knee (also a revision total knee arthroplasty)
Trial locations and contacts
1 site in 1 country.
United States1 site
Broward Health Sports Medicine
Fort Lauderdale, Florida, 33316
About this study
Official title: Prospective, Randomized Comparison of Postoperative Pain Control Results of Peri-articular Local Injection and Intra-capsular Injectinon of Bupivacaine Liposome Injectable Suspension After Total Knee Arthroplasty
The purpose of this study is to determine quantitative and qualitative differences in post-operative pain relief for patients undergoing primary total knee arthroplasty (TKA) who receive administration of a newly approved, long acting local anesthetic branded as ExparelTM (bupivacaine liposome injectable suspension) introduced by one of two different administration methods.
Group 1 would receive a predetermined and standardized dose of ExparelTM introduced directly into the joint capsule at the conclusion of the surgery, effectively bathing the joint in anesthetic solution.
Group 2 would receive the same predetermined and standardized dose of ExparelTM as a local infiltration anesthetic (LIA) by injecting it into the periarticular tissues in nine (9) standard sites at the conclusion of the surgery.
Read the detailed description
This study is being done to determine if a difference exists between two methods of intraoperative (during surgery) administration of a long-acting local anesthetic (pain relief).
Local pain relief medications are accepted as standard of care as a part of a comprehensive plan for pain relief following a total knee replacement (arthroplasty) (TKA). We expect that the addition of ExparelTM to the usual post-surgery pain control medicines and procedures will result in less need for additional pain medication. It is possible that local injection into the tissue around the total knee replacement joint (periarticular tissues) may provide more effective pain relief than injection directly into the joint (intracapsular) itself, or vice versa. It is also possible that pain relief with either method is approximately equivalent. On the day of surgery, each patient will undergo total knee arthroplasty and cared for utilizing the standard protocol for all patients that undergo total knee arthroplasty at Broward Health Medical Center.
Patients in Group 1 will receive the same amount of ExparelTM injected intracapsularly. Those in is Group 2 will receive a standardized medication regimen including ExparelTM by local infiltration into the periarticular tissues at the conclusion of their TKA procedure. Study participants will undergo injection in this manner until the conclusion of the study.
All subjects will be provided the same methods of postoperative pain control following their TKA surgery as those patients not enrolled in the study.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Intracapsular Injection, Periarticular Injection
- Keywords
- Knee arthroplasty, Exparel, Bupivacaine liposome, Total knee replacement, Pain control
- Medical subject headings
- Osteoarthritis, Knee, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intracapsular InjectionProcedure or surgery
Also called Intracapsular injection of bupivacaine liposome (ExparelTM)
The amount of bupivacaine liposome (ExparelTM) will be injected directly into the joint capsule (intracapsular injection), effectively "bathing" the joint in the medication.
Periarticular InjectionProcedure or surgery
Also called Periarticular injection of bupivacaine liposome (ExparelTM)
The amount of bupivacaine liposome (ExparelTM) will be injected periarticulary, via 9 standard periarticular tissue sites around the joint
| Study group | Role | What they receive |
|---|---|---|
| Intracapsular Injection | Experimental | Patients in the experimental group will undergo direct injection of ExparelTM into the knee joint; once the total knee replacement (arthroplasty) has been completed, patients will receive a given amount of ExparelTM administered during surgery into the joint where the knee replacement (arthroplasty) (TKA) was performed. Receives: Procedure: Intracapsular Injection |
| Periarticular Injection | Active comparator | Patients in this group will undergo local injection of ExparelTM to help to reduce post-surgery pain. Once the total knee replacement (arthroplasty) has been completed, patients in this group will receive a given amount of ExparelTM administered during surgery into the soft tissues around the bone where the knee replacement (arthroplasty) (TKA) was performed. Receives: Procedure: Periarticular Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Visual Analog Scale for Pain
Pre-Surgical visual analog scale for pain will be administered up to 2 months pre-surgery.
Post-Surgical visual analog scales will be administered as a "pain journal" in which patients will record their level of pain twice a day, once in the morning, and once in the evening for 1 week.
Measured: 8 weeks pre-surgery (Baseline/Day 0) and every day for 1 week, post-surgery (Day 1, 2, 3, 4, 5, 6, 7)
Secondary outcomes (1)
Change in Oxford Knee Score
Pre-surgical oxford knee questionnaires will be administered up to 2 months pre-surgery. Post-surgical questionnaires will be administered at the patient's first follow-up office visit, approximately 4 weeks post-surgery.
Measured: 8 weeks pre-surgery (baseline) and 4 weeks post surgery (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2014 (estimated)
- Study startApr 2014
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Broward Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, W Vincent Burke, MD, Broward Health
- Investigators
- William V Burke, M.D., Principal investigator, Broward Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02166632
- Sponsor's protocol ID
- BH130401
- Status last verified
- Feb 2016
- First submitted
- 13 Jun 2014
- Last updated
- 10 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized Comparison of Postoperative Pain Control Results of Peri-articular Local Injection and Intra-capsular Injectinon of Bupivacaine Liposome Injectable Suspension After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02166632
- Acronym / sponsor ID
- BH130401
- Conditions
- Osteoarthritis, Knee
- Keywords
- Knee arthroplasty, Exparel, Bupivacaine liposome, Total knee replacement, Pain control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Broward HealthUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 18 Jun 2014 (estimated)
- 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 quantitative and qualitative differences in post-operative pain relief for patients undergoing primary total knee arthroplasty (TKA) who receive administration of a newly approved, long acting local anesthetic branded as ExparelTM (bupivacaine liposome injectable suspension) introduced by one of two different administration methods.
Group 1 would receive a predetermined and standardized dose of ExparelTM introduced directly into the joint capsule at the conclusion of the surgery, effectively bathing the joint in anesthetic solution.
Group 2 would receive the same predetermined and standardized dose of ExparelTM as a local infiltration anesthetic (LIA) by injecting it into the periarticular tissues in nine (9) standard sites at the conclusion of the surgery.
Detailed description
This study is being done to determine if a difference exists between two methods of intraoperative (during surgery) administration of a long-acting local anesthetic (pain relief).
Local pain relief medications are accepted as standard of care as a part of a comprehensive plan for pain relief following a total knee replacement (arthroplasty) (TKA). We expect that the addition of ExparelTM to the usual post-surgery pain control medicines and procedures will result in less need for additional pain medication. It is possible that local injection into the tissue around the total knee replacement joint (periarticular tissues) may provide more effective pain relief than injection directly into the joint (intracapsular) itself, or vice versa. It is also possible that pain relief with either method is approximately equivalent. On the day of surgery, each patient will undergo total knee arthroplasty and cared for utilizing the standard protocol for all patients that undergo total knee arthroplasty at Broward Health Medical Center.
Patients in Group 1 will receive the same amount of ExparelTM injected intracapsularly. Those in is Group 2 will receive a standardized medication regimen including ExparelTM by local infiltration into the periarticular tissues at the conclusion of their TKA procedure. Study participants will undergo injection in this manner until the conclusion of the study.
All subjects will be provided the same methods of postoperative pain control following their TKA surgery as those patients not enrolled in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracapsular Injection | Experimental | Procedure: Intracapsular InjectionPatients in the experimental group will undergo direct injection of ExparelTM into the knee joint; once the total knee replacement (arthroplasty) has been completed, patients will receive a given amount of ExparelTM administered during surgery into the joint where the knee replacement (arthroplasty) (TKA) was performed. |
| Periarticular Injection | Active comparator | Procedure: Periarticular InjectionPatients in this group will undergo local injection of ExparelTM to help to reduce post-surgery pain. Once the total knee replacement (arthroplasty) has been completed, patients in this group will receive a given amount of ExparelTM administered during surgery into the soft tissues around the bone where the knee replacement (arthroplasty) (TKA) was performed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients must be over the age of 18
- Patients must have a preoperative diagnosis of osteoarthritis of the knee requiring total knee arthroplasty
Key exclusion criteria (7 listed)
- Allergy to ExparelTM or certain other local anesthetic agents
- Pregnant females or females who think they may become pregnant
- Markedly abnormal kidney function or renal disease
- History of substance abuse
- History of chronic pain requiring medication
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 |
|---|---|---|
| Intracapsular InjectionAlso: Intracapsular injection of bupivacaine liposome (ExparelTM)The amount of bupivacaine liposome (ExparelTM) will be injected directly into the joint capsule (intracapsular injection), effectively "bathing" the joint in the medication. | Procedure or surgery | Intracapsular Injection |
| Periarticular InjectionAlso: Periarticular injection of bupivacaine liposome (ExparelTM)The amount of bupivacaine liposome (ExparelTM) will be injected periarticulary, via 9 standard periarticular tissue sites around the joint | Procedure or surgery | Periarticular Injection |
Primary outcome
Change in Visual Analog Scale for Pain
Time frame: 8 weeks pre-surgery (Baseline/Day 0) and every day for 1 week, post-surgery (Day 1, 2, 3, 4, 5, 6, 7)
Pre-Surgical visual analog scale for pain will be administered up to 2 months pre-surgery. Post-Surgical visual analog scales will be administered as a "pain journal" in which patients will record their level of pain twice a day, once in the morning, and once in the evening for 1 week.
1 secondary outcome
Change in Oxford Knee Score
Time frame: 8 weeks pre-surgery (baseline) and 4 weeks post surgery (Day 28)
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 10 Feb 2016.
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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.
William V Burke, M.D. principal investigator
Broward Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracapsular Injection and Periarticular Injection in people with Osteoarthritis, Knee, run by Broward Health 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 2 inclusion and 7 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 10 Feb 2016. 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 in Visual Analog Scale for Pain (time frame: 8 weeks pre-surgery (Baseline/Day 0) and every day for 1 week, post-surgery (Day 1, 2, 3, 4, 5, 6, 7)). 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 10 Feb 2016.