Osteoarthritis of the ShoulderPhase 4NCT04134442
Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome
A Phase 4 study testing Bupivacaine Liposome Injection and Standard Therapy in people with Osteoarthritis of the Shoulder and Shoulder Pain, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
To improve pain control and decrease opioid requirements for subjects undergoing Total Shoulder Replacement. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis of the Shoulder, Shoulder Pain, Pain, Postoperative
- What is being tested?
- Bupivacaine Liposome Injection and Standard Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2019to 23 Sep 2021
- Phase
- Phase 4
- 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
- Adult subjects older than 18years old undergoing Total Shoulder Replacement (TSR) or reverse TSR surgery.
- Meet criteria for regional nerve block.
- Weight greater than 60kg (safety to keep liposomal bupivacaine and bupivacaine dosing below 3mg/kg).
Who cannot join
- Recent drug use
- Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control).
- Nerve injury (cervical stenosis, trauma, etc) of the surgical limb.
- Coagulopathy
- Subjects with significant liver disease (as amide type local anesthetics such as bupivacaine are metabolized by the liver).
- Infection near or in the area of the nerve block.
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- Subject refusal of regional anesthesia.
- Vulnerable populations (prisoners, mental impairment / dementia, etc).
- Subjects requiring interpreter services (not proficient in English).
- Subjects with poor cardio-pulmonary reserve who might not tolerate a hemi-diaphragmatic paralysis or hemi-diaphragmatic paresis.
Trial locations and contacts
1 site in 1 country.
United States1 site
UMASS Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
To improve pain control and decrease opioid requirements for subjects undergoing Total Shoulder Replacement.
Read the detailed description
For the pilot study the investigators will use a total of 20 cases per group.
A HIPAA Waiver will be used for screening purposes. The investigators will be using the electronic medical record system (EPIC) to screen for subjects in the University of Massachusetts Medical (UMass) system.
Subjects will be recruited and consented as described later in the study plan.
Subjects will be randomized to the two groups (standard therapy or BL) using a random number generator. The random number with the type of anesthetic will stored in envelopes and will be opened in sequence on each day of the interscalene nerve block (ISNB).
- Group 1: Standard therapy
- Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, or age as currently determined by acute pain service (APS) anesthesiologist)
- Preoperative, ultrasound guided ISNB with a bupivacaine mixture: 20ml 0.5% bupivacaine and epinephrine 1:200,000.
- Group 2: BL
- Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, age, or current therapy as currently determined by APS anesthesiologist)
- Pre-operative ultrasound guided ISNB with a 20ml mixture consisting of 10ml of 0.5% bupivacaine with epinephrine 1:200,000, and 10ml of BL 1.33%
In accordance with our current practice, all subjects will have premedication with midazolam and fentanyl and general anesthesia (GA) with endotracheal tube (ETT). Propofol will be used for induction of GA. During surgery, administration of short acting narcotics (fentanyl) will be at the discretion of the anesthesia team.
As BL will be used, no additional local anesthetics will be used during surgery (i.e. lidocaine for induction or maintenance of anesthesia, or local anesthetics for infiltration in the surgical field). Ketamine will not be used as an anesthetic / analgesic adjunct
After this, all patients will remain on our standard protocols. In the PACU, subjects will receive IV hydromorphone for pain control. Once on the post- operative floor, subjects pain will be managed with oxycodone as needed every 4 hours (5mg for moderate pain, 10mg for severe pain) and 0.4 mg IV hydromorphone for breakthrough pain.
Subject's postoperative opioid consumption and pain scores will be obtained from their charts. Subjects will fill out a Brief Pain Inventory Short Form pre-operatively, on post-operatively day (POD) 1, and POD 2 (if the patients have not been discharged from the hospital).
Blinding In this study, the investigators will work with the Investigational Drug Pharmacy, who will store the medications, and supply medications on the day of surgery. Subjects will be blinded, as all subjects will receive an ISNB. The surgeon, anesthesiology team, post-anesthesia care unit (PACU) and floor nurses will also be unaware of group assignment, and will use their clinical judgement and subjects' reporting when administering medications and recording pain scores. Surveys about subjects' satisfaction with pain control, as well as data collection from subjects' records will be done by study investigators that are not involved in performing injections.
The Anesthesiologists performing the nerve block will not be blinded (as the Bupivacaine Liposome solution is a suspension and is white, whereas bupivacaine solution is clear), but will not participate in further evaluations of the subjects or data collection.
- Being tested
- Bupivacaine Liposome Injection, Standard Therapy
- Keywords
- Exparel, Bupivacaine Liposome, Total Shoulder Replacement, Pain Management
- Medical subject headings
- Shoulder Pain, Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine Liposome InjectionDrug
Also called Standard Therapy and Bupivacaine Liposome 10ml 1.33%
- Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, age, or current therapy as currently determined by APS anesthesiologist)
- Pre-operative ultrasound guided ISNB with a 20ml mixture consisting of 10ml of 0.5% bupivacaine with epinephrine 1:200,000, and 10ml of BL 1.33%
Standard TherapyOther
- Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, or age as currently determined by acute pain service (APS) anesthesiologist)
- Preoperative, ultrasound guided ISNB with a bupivacaine mixture: 20ml 0.5% bupivacaine and epinephrine 1:200,000.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine Liposome | Experimental | 1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, age, or current therapy as currently determined by APS anesthesiologist).
2. Pre-operative ultrasound guided ISNB with a 20ml mixture consisting of 10ml of 0.5% bupivacaine with epinephrine 1:200,000, and 10ml of BL 1.33% Receives: Drug: Bupivacaine Liposome Injection |
| Standard therapy | Active comparator | 1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, or age as currently determined by acute pain service (APS) anesthesiologist).
2. Preoperative, ultrasound guided ISNB with a bupivacaine mixture: 20ml 0.5% bupivacaine and epinephrine 1:200,000. Receives: Other: Standard Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine Equivalent Dose of Opioids
Morphine equivalent dose (MED) of opioids within the first 24 hours after surgery (including PACU and medications on the floor)
Measured: First 24 hours
Secondary outcomes (6)
Morphine equivalent dose of opioids
Morphine equivalent dose (MED) of opioids within the first 24-48 hours after surgery (including PACU and medications on the floor)
Measured: 24-48 hours
Visual Analogue Scale Pain Score
Visual Analogue Scale Pain Score (VAS) in the first 24 hours, and 24-48 hours after surgery
Measured: 24-48 hours
Hospital Length of Stay
Hospital Length of Stay
Measured: Through study completion, an average of 2-3 days
Post-Operative Brief Pain Inventory Short Form
Brief Pain Inventory Short Form pre-operatively on POD 0, POD 1, and POD 2
Measured: <1 day, 1 day, and 2 days
Cost Analysis
Cost estimate of each technique
Measured: Through study completion, an average of 2-3 days
Opioid Administration
Time to administration of the first opioid
Measured: Up to 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2019
- Study start9 Dec 2019
- Primary completion23 Sep 2021
- Study completion23 Sep 2021
Why it stopped: A new large meta-analysis was published. The results showed the likelihood that liposomal bupivacaine and nerve blocks no longer offer significant contribution. Decision was made to terminate the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis of the ShoulderStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Chan, University of Massachusetts, Worcester
- Investigators
- Alexander Chan, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04134442
- Sponsor's protocol ID
- H00016941
- Status last verified
- Jun 2022
- First submitted
- 2 Oct 2019
- Last updated
- 6 Jul 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Pain Management After Total Shoulder Replacement Using Bupivacaine Liposome
- ClinicalTrials.gov ID
- NCT04134442
- Acronym / sponsor ID
- H00016941
- Keywords
- Exparel, Bupivacaine Liposome, Total Shoulder Replacement, Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: A new large meta-analysis was published. The results showed the likelihood that liposomal bupivacaine and nerve blocks no longer offer significant contribution. Decision was made to terminate the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 23 Sep 2021 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 22 Oct 2019 (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.
To improve pain control and decrease opioid requirements for subjects undergoing Total Shoulder Replacement.
Detailed description
For the pilot study the investigators will use a total of 20 cases per group.
A HIPAA Waiver will be used for screening purposes. The investigators will be using the electronic medical record system (EPIC) to screen for subjects in the University of Massachusetts Medical (UMass) system.
Subjects will be recruited and consented as described later in the study plan.
Subjects will be randomized to the two groups (standard therapy or BL) using a random number generator. The random number with the type of anesthetic will stored in envelopes and will be opened in sequence on each day of the interscalene nerve block (ISNB).
- Group 1: Standard therapy
- Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, or age as currently determined by acute pain service (APS) anesthesiologist)
- Preoperative, ultrasound guided ISNB with a bupivacaine mixture: 20ml 0.5% bupivacaine and epinephrine 1:200,000.
- Group 2: BL
- Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, age, or current therapy as currently determined by APS anesthesiologist)
- Pre-operative ultrasound guided ISNB with a 20ml mixture consisting of 10ml of 0.5% bupivacaine with epinephrine 1:200,000, and 10ml of BL 1.33%
In accordance with our current practice, all subjects will have premedication with midazolam and fentanyl and general anesthesia (GA) with endotracheal tube (ETT). Propofol will be used for induction of GA. During surgery, administration of short acting narcotics (fentanyl) will be at the discretion of the anesthesia team.
As BL will be used, no additional local anesthetics will be used during surgery (i.e. lidocaine for induction or maintenance of anesthesia, or local anesthetics for infiltration in the surgical field). Ketamine will not be used as an anesthetic / analgesic adjunct
After this, all patients will remain on our standard protocols. In the PACU, subjects will receive IV hydromorphone for pain control. Once on the post- operative floor, subjects pain will be managed with oxycodone as needed every 4 hours (5mg for moderate pain, 10mg for severe pain) and 0.4 mg IV hydromorphone for breakthrough pain.
Subject's postoperative opioid consumption and pain scores will be obtained from their charts. Subjects will fill out a Brief Pain Inventory Short Form pre-operatively, on post-operatively day (POD) 1, and POD 2 (if the patients have not been discharged from the hospital).
Blinding In this study, the investigators will work with the Investigational Drug Pharmacy, who will store the medications, and supply medications on the day of surgery. Subjects will be blinded, as all subjects will receive an ISNB. The surgeon, anesthesiology team, post-anesthesia care unit (PACU) and floor nurses will also be unaware of group assignment, and will use their clinical judgement and subjects' reporting when administering medications and recording pain scores. Surveys about subjects' satisfaction with pain control, as well as data collection from subjects' records will be done by study investigators that are not involved in performing injections.
The Anesthesiologists performing the nerve block will not be blinded (as the Bupivacaine Liposome solution is a suspension and is white, whereas bupivacaine solution is clear), but will not participate in further evaluations of the subjects or data collection.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine Liposome | Experimental | Drug: Bupivacaine Liposome Injection1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, age, or current therapy as currently determined by APS anesthesiologist). 2. Pre-operative ultrasound guided ISNB with a 20ml mixture consisting of 10ml of 0.5% bupivacaine with epinephrine 1:200,000, and 10ml of BL 1.33% |
| Standard therapy | Active comparator | Other: Standard Therapy1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, or age as currently determined by acute pain service (APS) anesthesiologist). 2. Preoperative, ultrasound guided ISNB with a bupivacaine mixture: 20ml 0.5% bupivacaine and epinephrine 1:200,000. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult subjects older than 18years old undergoing Total Shoulder Replacement (TSR) or reverse TSR surgery.
- Meet criteria for regional nerve block.
- Weight greater than 60kg (safety to keep liposomal bupivacaine and bupivacaine dosing below 3mg/kg).
Key exclusion criteria (10 listed)
- Recent drug use
- Subjects on chronic buprenorphine therapy (either for opioid replacement or pain control).
- Nerve injury (cervical stenosis, trauma, etc) of the surgical limb.
- Coagulopathy
- Subjects with significant liver disease (as amide type local anesthetics such as bupivacaine are metabolized by the liver).
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 |
|---|---|---|
| Bupivacaine Liposome InjectionAlso: Standard Therapy and Bupivacaine Liposome 10ml 1.33%1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, age, or current therapy as currently determined by APS anesthesiologist) 2. Pre-operative ultrasound guided ISNB with a 20ml mixture consisting of 10ml of 0.5% bupivacaine with epinephrine 1:200,000, and 10ml of BL 1.33% | Drug | Bupivacaine Liposome |
| Standard Therapy1. Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, or age as currently determined by acute pain service (APS) anesthesiologist) 2. Preoperative, ultrasound guided ISNB with a bupivacaine mixture: 20ml 0.5% bupivacaine and epinephrine 1:200,000. | Other | Standard therapy |
Primary outcome
Morphine Equivalent Dose of Opioids
Time frame: First 24 hours
Morphine equivalent dose (MED) of opioids within the first 24 hours after surgery (including PACU and medications on the floor)
6 secondary outcomes
Morphine equivalent dose of opioids
Time frame: 24-48 hours
Visual Analogue Scale Pain Score
Time frame: 24-48 hours
Hospital Length of Stay
Time frame: Through study completion, an average of 2-3 days
Post-Operative Brief Pain Inventory Short Form
Time frame: <1 day, 1 day, and 2 days
Cost Analysis
Time frame: Through study completion, an average of 2-3 days
Opioid Administration
Time frame: Up to 72 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2022.
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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.
Alexander Chan, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine Liposome Injection and Standard Therapy in people with Osteoarthritis of the Shoulder and Shoulder Pain, run by University of Massachusetts, Worcester 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 10 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: withdrawn, as of the sponsor's last update on 6 Jul 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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?
Morphine Equivalent Dose of Opioids (time frame: First 24 hours). 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 6 Jul 2022.