Osteoarthritis, KneeNCT02197273
Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)
A study testing Liposomal bupivacaine in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by OhioHealth at 1 site in United States.
Trial summary
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis, Shoulder
- What is being tested?
- Liposomal bupivacaine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Clinical diagnosis of osteoarthritis
- Elected to undergo primary TKA, THA, or TSA
Who cannot join
- Age < 18 years
- Pregnant or breastfeeding
- Non-English speaking
- Unable to give informed consent
- Previous open hip, knee or shoulder surgery
- Pre-determined patients discharging to ECF
Show all 12Show fewer
- Patients with allergies to bupivacaine
- Patients currently taking opioid pain medication
- Patients with contraindication to nerve blocks
- Patients undergoing simultaneous bilateral joint replacement, as this would require >1 dose of liposomal bupivacaine (Exparel®) per patient for each surgical site
- Patients with severe hepatic disease
- Patients with chronic heart disease as defined as a decreased ejection fraction
Trial locations and contacts
1 site in 1 country.
United States1 site
OhioHealth Riverside Methodist Hospital
Columbus, Ohio, 43214
About this study
Official title: Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty
The purpose of this study is to determine whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.
Read the detailed description
Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total joint arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total joint arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.
- Being tested
- Liposomal bupivacaine, Standard of care analgesia
- Keywords
- Total knee arthroplasty, Total shoulder arthroplasty, Total hip arthroplasty, Total joint arthroplasty, Hip replacement, Knee replacement, Shoulder replacement
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis, Hip, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
Standard of care analgesiaDrug
Also called Bupivacaine, Ropivacaine, Fentanyl, Solumedrol
| Study group | Role | What they receive |
|---|---|---|
| Standard of care analgesia | Active comparator | Total Hip Arthroplasty (THA):
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine
Injection into capsular tissue after placement of the acetabular component:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
Total Knee Arthroplasty (TKA):
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc
Injection into posterior capsule of the knee:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
Total Shoulder Arthroplasty (TSA):
All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days. Receives: Drug: Standard of care analgesia |
| Liposomal bupivacaine | Experimental | THA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue
TKA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue
TSA:
All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle Receives: Drug: Liposomal bupivacaine; Drug: Standard of care analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay in Hospital (Days)
Measured: Participants were followed for the duration of hospital stay, an expected average of 3 days
Secondary outcomes (2)
Time to Post-operative Rescue Opioids (Hours)
Measured: Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days
Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days
Measured: Date of discharge through 30 days following discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- OhioHealth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Napier, OhioHealth
- Investigators
- Deborah Napier, BSN,RN,MA, Principal investigator, OhioHealth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02197273
- Sponsor's protocol ID
- OH1-14-00529
- Status last verified
- Aug 2016
- First submitted
- 17 Jul 2014
- Last updated
- 21 Oct 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty
- ClinicalTrials.gov ID
- NCT02197273
- Acronym / sponsor ID
- OH1-14-00529
- Keywords
- Total knee arthroplasty, Total shoulder arthroplasty, Total hip arthroplasty, Total joint arthroplasty, Hip replacement, Knee replacement, Shoulder replacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 211 participants (actual)
- Lead sponsor
- OhioHealthUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 22 Jul 2014 (estimated)
- Results
- Posted 21 Oct 2016
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 whether liposomal bupivacaine is effective in the management of pain following total joint arthroplasty, as compared to standard of care analgesia.
Detailed description
Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated bupivacaine. It is designed to be injected at the time of surgery into the local soft tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®) has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an attractive option in total joint arthroplasty patients. Combined with the proven efficacy of regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended pain relief following total joint arthroplasty. This has the potential to avoid the need for opioid medications. With better pain control, medication side effects can be avoided and patient's length of stay in the hospital can be shortened.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care analgesia | Active comparator | Drug: Standard of care analgesiaTotal Hip Arthroplasty (THA): All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine Injection into capsular tissue after placement of the acetabular component: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline Total Knee Arthroplasty (TKA): All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc Injection into posterior capsule of the knee: 0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline Total Shoulder Arthroplasty (TSA): All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days. |
| Liposomal bupivacaine | Experimental | Drug: Liposomal bupivacaine, Drug: Standard of care analgesiaTHA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue TKA: Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue TSA: All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine. Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of osteoarthritis
- Elected to undergo primary TKA, THA, or TSA
Key exclusion criteria (12 listed)
- Age < 18 years
- Pregnant or breastfeeding
- Non-English speaking
- Unable to give informed consent
- Previous open hip, knee or shoulder surgery
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 |
|---|---|---|
| Liposomal bupivacaineAlso: Exparel | Drug | Liposomal bupivacaine |
| Standard of care analgesiaAlso: Bupivacaine, Ropivacaine, Fentanyl, Solumedrol | Drug | Liposomal bupivacaine, Standard of care analgesia |
Primary outcome
Length of Stay in Hospital (Days)
Time frame: Participants were followed for the duration of hospital stay, an expected average of 3 days
2 secondary outcomes
Time to Post-operative Rescue Opioids (Hours)
Time frame: Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days
Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days
Time frame: Date of discharge through 30 days following discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Deborah Napier, BSN,RN,MA principal investigator
OhioHealth
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Liposomal bupivacaine in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by OhioHealth 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 12 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 21 Oct 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?
Yes. Results are posted in the registry (first posted 21 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Length of Stay in Hospital (Days) (time frame: Participants were followed for the duration of hospital stay, an expected average of 3 days). 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 21 Oct 2016.