Postoperative PainPhase 4NCT07614802
Exparel and Dexamethasone
A Phase 4 study testing Liposomal Bupivacaine with Bupivacaine and Dexamethasone in people with Postoperative Pain and Shoulder Arthroscopic Surgeries, run by Duke University.
Trial summary
This prospective randomized clinical trial evaluates the duration of sensory blockade in patients undergoing shoulder surgery receiving interscalene brachial plexus blocks with either liposomal bupivacaine alone or liposomal bupivacaine combined with dexamethasone. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Pain, Shoulder Arthroscopic Surgeries
- What is being tested?
- Liposomal Bupivacaine with Bupivacaine and Dexamethasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 1 Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- Adults aged 18 to 80 years
- ASA physical status 1-3
- Undergoing primary shoulder surgery with interscalene nerve block
Who cannot join
- ASA 4 or 5
- Revision shoulder surgery
- Daily chronic opioid use (over 3 months of continuous opioid use)
- Inability to communicate pain scores or need for analgesia
- Infection at the site of block placement
- Age under 18 years old or greater than 80 years old
Show all 14Show fewer
- Pregnant women (as determined by point-of-care serum bHCG)
- Intolerance/allergy to local anesthetics
- Weight <50 kg
- BMI > 40
- severe pulmonary disease including chronic obstructive pulmonary disease and restrictive lung disease
- Suspected, or known addiction to or abuse of illicit drug(s), prescription medicine(s), or alcohol within the past 2 years.
- Uncontrolled anxiety, schizophrenia, or other psychiatric disorder that, in the opinion of the investigator, may interfere with study assessments or compliance.
- Current or historical evidence of any clinically significant disease or condition that, in the opinion of the investigator, may increase the risk of surgery or complicate the subject's postoperative course.
About this study
Official title: The Power Couple of Regional Analgesia? A Prospective Randomized Controlled Trial Comparing Block Duration With Liposomal Bupivacaine and Dexamethasone
This prospective randomized clinical trial evaluates the duration of sensory blockade in patients undergoing shoulder surgery receiving interscalene brachial plexus blocks with either liposomal bupivacaine alone or liposomal bupivacaine combined with dexamethasone.
- Being tested
- Liposomal Bupivacaine with Bupivacaine, Dexamethasone
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liposomal Bupivacaine with BupivacaineDrug
Administration of an interscalene brachial plexus nerve block using 10 mL liposomal bupivacaine (133 mg) and 20 mL of 0.5% bupivacaine for postoperative analgesia following shoulder surgery.
DexamethasoneDrug
6 mg preservative-free dexamethasone
| Study group | Role | What they receive |
|---|---|---|
| Liposomal Bupivacaine Alone | Active comparator | Participants receive an interscalene brachial plexus nerve block consisting of 10 mL liposomal bupivacaine (133 mg) combined with 20 mL of 0.5% bupivacaine. This regimen represents standard of care for prolonged regional analgesia in shoulder surgery. Receives: Drug: Liposomal Bupivacaine with Bupivacaine |
| Liposomal Bupivacaine + Dexamethasone | Experimental | Participants receive an interscalene brachial plexus nerve block consisting of 10 mL liposomal bupivacaine (133 mg) combined with 20 mL of 0.5% bupivacaine and 6 mg preservative-free dexamethasone. This arm evaluates whether the addition of dexamethasone prolongs sensory blockade duration compared to liposomal bupivacaine alone. Receives: Drug: Liposomal Bupivacaine with Bupivacaine; Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
time until resolution of sensory block
Patients will be called daily until resolution of their sensory block
Measured: 0-10 days
Secondary outcomes (4)
duration of motor blockade
Measured: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively
pain scores (scale of 0-10)
Numeric Pain Rating Scale (NPRS): A score of 0 means "no pain," and 10 means "the worst pain imaginable
Measured: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively
opioid consumption (in oral morphine equivalents)
Measured: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively
known side effects of interscalene blocks
Measured: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emily Hall, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07614802
- Sponsor's protocol ID
- PRO00119364
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Power Couple of Regional Analgesia? A Prospective Randomized Controlled Trial Comparing Block Duration With Liposomal Bupivacaine and Dexamethasone
- ClinicalTrials.gov ID
- NCT07614802
- Acronym / sponsor ID
- PRO00119364
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 29 May 2026 (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.
This prospective randomized clinical trial evaluates the duration of sensory blockade in patients undergoing shoulder surgery receiving interscalene brachial plexus blocks with either liposomal bupivacaine alone or liposomal bupivacaine combined with dexamethasone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposomal Bupivacaine Alone | Active comparator | Drug: Liposomal Bupivacaine with BupivacaineParticipants receive an interscalene brachial plexus nerve block consisting of 10 mL liposomal bupivacaine (133 mg) combined with 20 mL of 0.5% bupivacaine. This regimen represents standard of care for prolonged regional analgesia in shoulder surgery. |
| Liposomal Bupivacaine + Dexamethasone | Experimental | Drug: Liposomal Bupivacaine with Bupivacaine, Drug: DexamethasoneParticipants receive an interscalene brachial plexus nerve block consisting of 10 mL liposomal bupivacaine (133 mg) combined with 20 mL of 0.5% bupivacaine and 6 mg preservative-free dexamethasone. This arm evaluates whether the addition of dexamethasone prolongs sensory blockade duration compared to liposomal bupivacaine alone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 18 to 80 years
- ASA physical status 1-3
- Undergoing primary shoulder surgery with interscalene nerve block
Key exclusion criteria (14 listed)
- ASA 4 or 5
- Revision shoulder surgery
- Daily chronic opioid use (over 3 months of continuous opioid use)
- Inability to communicate pain scores or need for analgesia
- Infection at the site of block placement
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 Bupivacaine with BupivacaineAdministration of an interscalene brachial plexus nerve block using 10 mL liposomal bupivacaine (133 mg) and 20 mL of 0.5% bupivacaine for postoperative analgesia following shoulder surgery. | Drug | Liposomal Bupivacaine + Dexamethasone, Liposomal Bupivacaine Alone |
| Dexamethasone6 mg preservative-free dexamethasone | Drug | Liposomal Bupivacaine + Dexamethasone |
Primary outcome
time until resolution of sensory block
Time frame: 0-10 days
Patients will be called daily until resolution of their sensory block
4 secondary outcomes
duration of motor blockade
Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively
pain scores (scale of 0-10)
Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively
opioid consumption (in oral morphine equivalents)
Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively
known side effects of interscalene blocks
Time frame: 2, 12, 24, 36, 48, 72, and 96 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- 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.
Emily Hall principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liposomal Bupivacaine with Bupivacaine and Dexamethasone in people with Postoperative Pain and Shoulder Arthroscopic Surgeries, run by Duke University.
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 14 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: opening soon, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
time until resolution of sensory block (time frame: 0-10 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 19 Oct 2026.