AnalgesiaPhase 3NCT04974385
Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty
A Phase 3 study testing Liposomal bupivacaine and Bupivacaine in people with Analgesia, run by University of Virginia at 1 site in United States.
Trial summary
The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Analgesia
- What is being tested?
- Liposomal bupivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Aug 2021to 4 May 2022
- Phase
- Phase 3
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years of age or older
- Undergoing total shoulder arthroplasty
- Willing and able to sign consent form to participate in study
Who cannot join
- < 18 years of age
- Unwilling or unable to sign consent form to participate in study
- Allergy to local anesthetic
- Medical contraindication to interscalene nerve block
- Chronic opioid use
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Medical Center
Charlottesville, Virginia, 22903
About this study
Official title: Comparison of Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty: a Prospective, Double-blinded, Noninferiority Trial
The objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.
- Conditions
- Analgesia
- Being tested
- Liposomal bupivacaine, Bupivacaine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal bupivacaineDrug
Also called Exparel
Validate the analgesic efficacy of admixed LB + bupivacaine compared with plain bupivacaine when injected for ISNB for total shoulder arthroplasty.
BupivacaineDrug
Active comparator as standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine | Experimental | Experimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL. Receives: Drug: Liposomal bupivacaine; Drug: Bupivacaine |
| Non-liposomal Bupivacaine | Active comparator | Comparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption
Morphine equivalents used during first 72 hours after surgery
Measured: 72 hours postoperative
Secondary outcomes (4)
Numeric Rating Scale Reported Pain Scores
Patient reported pain scores using the numeric rating scale from 0 to 10 where 0 means no pain and 10 means worst possible pain
Measured: 72 hours postoperative
Nerve Block Related Adverse Events
Any adverse event determined to be caused as a result of having a nerve block to include but not limited to toxicity, allergic reaction, nerve injury.
Measured: 72 hours postoperative
Patients with Additional, Unanticipated Pain Related Medical Encounters
Any unanticipated, unplanned, pain related phone calls to surgeon or anesthesiologist for rescue pain treatment, pain related emergency department visits or primary care physician visits for pain treatment
Measured: 72 hours postoperative
Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale
Patient reported satisfaction with their postoperative pain control using the numeric rating scale from 0 to 10 where 0 means completely dissatisfied and 10 means completely satisfied
Measured: 72 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start4 Aug 2021
- Primary completion30 Apr 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, D. Aric Elmer, MD, University of Virginia
- Investigators
- Donald A Elmer, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974385
- Sponsor's protocol ID
- HSR210190
- Status last verified
- Nov 2022
- First submitted
- 3 Jul 2021
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Liposomal Bupivacaine Versus Non-liposomal Bupivacaine for Total Shoulder Arthroplasty: a Prospective, Double-blinded, Noninferiority Trial
- ClinicalTrials.gov ID
- NCT04974385
- Acronym / sponsor ID
- HSR210190
- Conditions
- Analgesia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 4 Aug 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 23 Jul 2021 (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 objective of this study is to validate the analgesic efficacy of admixed Liposomal bupivacaine (LB) + bupivacaine compared with plain bupivacaine when injected for interscalene nerve block (ISNB) for total shoulder arthroplasty (TSA). We hypothesize that admixed LB will be non-inferior to plain bupivacaine in terms of postoperative opioid consumption following TSA. The primary outcome of this study will be opioid consumption over the first 72 hours following surgery. Secondary outcomes will include: pain scores, opioid-related adverse events, block related adverse events, pain related phone calls, pain related ED visits and patient satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine | Experimental | Drug: Liposomal bupivacaine, Drug: BupivacaineExperimental group will receive ISNB with admixed LB (10 mL) and 0.5% bupivacaine (10 mL) total of 20 mL. |
| Non-liposomal Bupivacaine | Active comparator | Drug: BupivacaineComparator group will receive ISNB with 20 mL of 0.5% non-liposomal bupivacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults 18 years of age or older
- Undergoing total shoulder arthroplasty
- Willing and able to sign consent form to participate in study
Key exclusion criteria (5 listed)
- < 18 years of age
- Unwilling or unable to sign consent form to participate in study
- Allergy to local anesthetic
- Medical contraindication to interscalene nerve block
- Chronic opioid use
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: ExparelValidate the analgesic efficacy of admixed LB + bupivacaine compared with plain bupivacaine when injected for ISNB for total shoulder arthroplasty. | Drug | Liposomal Bupivacaine |
| BupivacaineActive comparator as standard of care. | Drug | Liposomal Bupivacaine, Non-liposomal Bupivacaine |
Primary outcome
Opioid Consumption
Time frame: 72 hours postoperative
Morphine equivalents used during first 72 hours after surgery
4 secondary outcomes
Numeric Rating Scale Reported Pain Scores
Time frame: 72 hours postoperative
Nerve Block Related Adverse Events
Time frame: 72 hours postoperative
Patients with Additional, Unanticipated Pain Related Medical Encounters
Time frame: 72 hours postoperative
Patient Reported Satisfaction with Postoperative Pain Control Using the Numeric Rating Scale
Time frame: 72 hours postoperative
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 3 Nov 2022.
- 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.
Donald A Elmer, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Liposomal bupivacaine and Bupivacaine in people with Analgesia, run by University of Virginia 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 3 inclusion and 5 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 3 Nov 2022. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Opioid Consumption (time frame: 72 hours postoperative). 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 3 Nov 2022.