Shoulder PainPhase 4NCT04047446
Liposomal Bupivacaine vs Dexamethasone ISB
A Phase 4 study testing Exparel 133 MG Per 10 ML Injection and Dexamethasone in people with Shoulder Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Exparel 133 MG Per 10 ML Injection and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2019to 19 Mar 2021
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- Age 18 years or older
- Scheduled for elective outpatient arthroscopic shoulder surgery
Who cannot join
- History of allergy to local anesthetic, or one of the study medications
- Pre-existing neurological deficits
- Psychiatric or cognitive disorders that prohibit patients from following study protocol
- History of drug or alcohol abuse
- Chronic opioid use (longer than 3 months)
- Chronic pain syndromes
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- Infection at the site of injection
- Patients with severe pulmonary disease
- Herniated cervical disc, cervical myelopathy
- Contraindication for general anesthesia and/or interscalene nerve block
- Pregnancy
- Open shoulder arthrotomies.
- Non English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Prolonging the Interscalene Brachial Plexus Block by Adding Liposomal Bupivacaine or Preservative Free Dexamethasone to Bupivacaine: a Non-inferiority Trial
In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.
- Conditions
- Shoulder Pain
- Being tested
- Exparel 133 MG Per 10 ML Injection, Dexamethasone
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exparel 133 MG Per 10 ML InjectionDrug
Also called Liposomal Bupivacaine
10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
DexamethasoneDrug
15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
| Study group | Role | What they receive |
|---|---|---|
| Liposomal bupivacaine & standard bupivacaine | Experimental | Not described Receives: Drug: Exparel 133 MG Per 10 ML Injection |
| Standard bupivacaine & dexamethasone | Active comparator | Not described Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours
NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.
Measured: First 72 hours pain
Secondary outcomes (10)
Numerical Rating Scale (NRS) Pain at Rest
NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome.
Measured: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Numerical Rating Scale (NRS) Pain With Movement
NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome.
Measured: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Opioid Consumption
Opioid consumption, measured in oral morphine equivalents
Measured: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Patient Satisfaction With Pain Management: Scale
Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction
Measured: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Brief Pain Inventory Short-form
The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life.
Measured: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Duration of Analgesic Block
Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked "When did your pain relief from the block completely wear off?" This indicates the block duration.
Measured: 24, 48, 72, 96 (if needed) hours postoperatively
Sensory Resolution
Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.
Measured: 24, 48, 72, 96 (if needed) hours postoperatively
Motor Block Resolution
Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.
Measured: 24, 48, 72, 96 (if needed) hours postoperatively
Time to Readiness for Discharge
Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System.
Measured: Postanesthesia care unit (0-6 hours postoperative)
Postanesthesia Care Unit Length of Stay
Total length of PACU stay as defined by time of PACU admission to PACU discharge.
Measured: Postanesthesia care unit (0-6 hours postoperative)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2019
- Study start11 Jul 2019
- Primary completion15 Mar 2021
- Study completion19 Mar 2021
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 Shoulder PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Kim, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047446
- Sponsor's protocol ID
- 2019-0424
- Status last verified
- Jul 2022
- First submitted
- 3 Jul 2019
- Last updated
- 1 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonging the Interscalene Brachial Plexus Block by Adding Liposomal Bupivacaine or Preservative Free Dexamethasone to Bupivacaine: a Non-inferiority Trial
- ClinicalTrials.gov ID
- NCT04047446
- Acronym / sponsor ID
- 2019-0424
- Conditions
- Shoulder Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- 11 Jul 2019 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 6 Aug 2019 (actual)
- Results
- Posted 1 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal bupivacaine & standard bupivacaine | Experimental | Drug: Exparel 133 MG Per 10 ML Injection |
| Standard bupivacaine & dexamethasone | Active comparator | Drug: Dexamethasone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA I-III
- Age 18 years or older
- Scheduled for elective outpatient arthroscopic shoulder surgery
Key exclusion criteria (13 listed)
- History of allergy to local anesthetic, or one of the study medications
- Pre-existing neurological deficits
- Psychiatric or cognitive disorders that prohibit patients from following study protocol
- History of drug or alcohol abuse
- Chronic opioid use (longer than 3 months)
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 |
|---|---|---|
| Exparel 133 MG Per 10 ML InjectionAlso: Liposomal Bupivacaine10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) | Drug | Liposomal bupivacaine & standard bupivacaine |
| Dexamethasone15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected | Drug | Standard bupivacaine & dexamethasone |
Primary outcome
Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours
Time frame: First 72 hours pain
NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.
10 secondary outcomes
Numerical Rating Scale (NRS) Pain at Rest
Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Numerical Rating Scale (NRS) Pain With Movement
Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Opioid Consumption
Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Patient Satisfaction With Pain Management: Scale
Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Brief Pain Inventory Short-form
Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7
Duration of Analgesic Block
Time frame: 24, 48, 72, 96 (if needed) hours postoperatively
Sensory Resolution
Time frame: 24, 48, 72, 96 (if needed) hours postoperatively
Motor Block Resolution
Time frame: 24, 48, 72, 96 (if needed) hours postoperatively
Time to Readiness for Discharge
Time frame: Postanesthesia care unit (0-6 hours postoperative)
Postanesthesia Care Unit Length of Stay
Time frame: Postanesthesia care unit (0-6 hours postoperative)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
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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.
David Kim, MD principal investigator
Hospital for Special Surgery, New York
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 Exparel 133 MG Per 10 ML Injection and Dexamethasone in people with Shoulder Pain, run by Hospital for Special Surgery, New York 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 13 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 1 Aug 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?
Yes. Results are posted in the registry (first posted 1 Aug 2022). 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?
Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours (time frame: First 72 hours pain). 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 1 Aug 2022.