NCT04047446 is a Phase 4 clinical trial of Exparel 133 MG Per 10 ML Injection in Shoulder Pain, sponsored by Hospital for Special Surgery, New York.

Who is sponsoring NCT04047446?

NCT04047446 is sponsored by Hospital for Special Surgery, New York.

What drugs are being tested in NCT04047446?

Interventions in NCT04047446: Exparel 133 MG Per 10 ML Injection, Dexamethasone.

What condition does NCT04047446 study?

NCT04047446 studies Shoulder Pain.

Is NCT04047446 still recruiting?

NCT04047446 is currently completed. Last updated 1 August 2022.

Are results published for NCT04047446?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2022-08-01 · How we verify

NCT04047446

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Liposomal Bupivacaine vs Dexamethasone ISB

Completed Phase 4 Results posted Last updated 1 August 2022

What this trial tests

Phase 4 trial testing Exparel 133 MG Per 10 ML Injection in Shoulder Pain in 112 participants. Completed in 19 March 2021.

Timeline

11 July 2019

Primary endpoint
15 March 2021

19 March 2021

Quick facts

Lead sponsor	Hospital for Special Surgery, New York
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	112
Start date	11 July 2019
Primary completion	15 March 2021
Estimated completion	19 March 2021
Sites	1 location across United States

Drugs / interventions tested

Exparel 133 MG Per 10 ML Injection — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →

Conditions studied

Shoulder Pain — all drugs for Shoulder Pain →

Sponsor

Hospital for Special Surgery, New York

Who can join

Adults 18 to 80, any sex, with Shoulder Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours Primary · 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.

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	2.4	± 1.9
Standard Bupivacaine & Dexamethasone	3.4	± 1.9

Numerical Rating Scale (NRS) Pain at Rest Secondary · Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

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.

Postanesthesia care unit (0-6 hours postoperative)

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	1.3	± 1.9
Standard Bupivacaine & Dexamethasone	0.9	± 1.8

Postoperative day 1

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	2.1	± 2.6
Standard Bupivacaine & Dexamethasone	3.0	± 2.5

Postoperative day 2

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	2.5	± 2.3
Standard Bupivacaine & Dexamethasone	4.1	± 2.7

Postoperative day 3

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	2.4	± 2.2
Standard Bupivacaine & Dexamethasone	3.3	± 2.4

Postoperative day 4

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	2.5	± 2.0
Standard Bupivacaine & Dexamethasone	3.0	± 2.2

Postoperative day 7

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	1.7	± 2.0
Standard Bupivacaine & Dexamethasone	2.3	± 2.2

Numerical Rating Scale (NRS) Pain With Movement Secondary · Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

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.

Postanesthesia care unit (0-6 hours postoperative)

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	8.9	± 4.3
Standard Bupivacaine & Dexamethasone	9.98	± 3.2

Postoperative day 1

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	4.0	± 3.1
Standard Bupivacaine & Dexamethasone	4.3	± 3.1

Postoperative day 2

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	4.1	± 2.9
Standard Bupivacaine & Dexamethasone	5.6	± 3.1

Postoperative day 3

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	4.0	± 2.7
Standard Bupivacaine & Dexamethasone	5.3	± 2.3

Postoperative day 4

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	4.0	± 2.8
Standard Bupivacaine & Dexamethasone	4.9	± 2.4

Postoperative day 7

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	3.9	± 2.6
Standard Bupivacaine & Dexamethasone	4.7	± 2.5

Opioid Consumption Secondary · 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, measured in oral morphine equivalents

Postanesthesia care unit (0-6 hours postoperative)

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	1.8	± 4.5
Standard Bupivacaine & Dexamethasone	1.7	± 4.6

Postoperative day 1

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	4.8	± 8.6
Standard Bupivacaine & Dexamethasone	8.1	± 10.4

Postoperative day 2

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	12.3	± 15.6
Standard Bupivacaine & Dexamethasone	18.2	± 20.8

Postoperative day 3

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	8.9	± 12.5
Standard Bupivacaine & Dexamethasone	13.2	± 14.0

Postoperative day 4

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	6.9	± 13.8
Standard Bupivacaine & Dexamethasone	9.7	± 15.5

Postoperative day 7

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	3.7	± 7.4
Standard Bupivacaine & Dexamethasone	3.3	± 7.2

Patient Satisfaction With Pain Management: Scale Secondary · Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

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

Postanesthesia care unit (0-6 hours postoperative)

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	9.4	± 1.3
Standard Bupivacaine & Dexamethasone	9.8	± 0.5

Postoperative day 1

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	9.3	± 1.4
Standard Bupivacaine & Dexamethasone	9.2	± 1.6

Postoperative day 2

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	8.9	± 2.1
Standard Bupivacaine & Dexamethasone	8.6	± 1.8

Postoperative day 3

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	9.2	± 1.4
Standard Bupivacaine & Dexamethasone	8.6	± 1.7

Postoperative day 4

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	9.1	± 1.2
Standard Bupivacaine & Dexamethasone	8.5	± 1.7

Postoperative day 7

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	9.1	± 1.5
Standard Bupivacaine & Dexamethasone	8.4	± 2.1

Brief Pain Inventory Short-form Secondary · Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

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.

Postanesthesia care unit (0-6 hours postoperative)

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	1.2	± 2.0
Standard Bupivacaine & Dexamethasone	0.6	± 1.4

Postoperative day 1

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	1.4	± 2.0
Standard Bupivacaine & Dexamethasone	1.8	± 2.3

Postoperative day 2

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	2.4	± 2.3
Standard Bupivacaine & Dexamethasone	3.6	± 2.5

Postoperative day 3

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	2.2	± 2.0
Standard Bupivacaine & Dexamethasone	3.4	± 2.1

Postoperative day 4

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	2.5	± 2.3
Standard Bupivacaine & Dexamethasone	3.6	± 2.1

Postoperative day 7

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	2.2	± 2.1
Standard Bupivacaine & Dexamethasone	2.9	± 2.1

Duration of Analgesic Block Secondary · 24, 48, 72, 96 (if needed) hours postoperatively

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.

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	26	20 – 42
Standard Bupivacaine & Dexamethasone	27	20 – 39

Sensory Resolution Secondary · 24, 48, 72, 96 (if needed) hours postoperatively

Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	27	21 – 44
Standard Bupivacaine & Dexamethasone	31	20 – 42

Motor Block Resolution Secondary · 24, 48, 72, 96 (if needed) hours postoperatively

Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	27	21 – 48
Standard Bupivacaine & Dexamethasone	27	19 – 40

Time to Readiness for Discharge Secondary · Postanesthesia care unit (0-6 hours postoperative)

Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System.

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	90	60 – 119
Standard Bupivacaine & Dexamethasone	90	75 – 119

Postanesthesia Care Unit Length of Stay Secondary · Postanesthesia care unit (0-6 hours postoperative)

Total length of PACU stay as defined by time of PACU admission to PACU discharge.

Group	Value	95% CI
Liposomal Bupivacaine & Standard Bupivacaine	163.5	138 – 197
Standard Bupivacaine & Dexamethasone	163	145 – 197

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 14 days following surgery. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Liposomal Bupivacaine & Standard Bupivacaine

Serious: 0/55 (0%)

Deaths: 0/55

Standard Bupivacaine & Dexamethasone

Serious: 0/56 (0%)

Deaths: 0/56

Other adverse events (2 terms — click to expand)

Reaction	System	Liposomal Bupivacaine & St…	Standard Bupivacaine & Dex…
Postoperative neurologic symptoms at 7 days after surgery	Nervous system disorders	—	—
Postoperative neurologic symptoms at 14 days after surgery	Nervous system disorders	—	—

Data from ClinicalTrials.gov NCT04047446 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Shoulder Pain

Currently open trials in the same condition.

NCT07493226 — Efficacy of Chemically Distinct Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) and Pain Phenotypes in Adhesive Capsulitis · NA · recruiting
NCT07493213 — USG-Guided Shoulder Injections in Frozen Shoulder · NA · recruiting
NCT07424638 — Interscalene Block Versus Anterior Suprascapular Block for Post-Thoracotomy Shoulder Pain · NA · recruiting
NCT07394673 — Ultrasound-Guided Serratus Posterior Superior Intercostal Plane Block for Analgesia in Arthroscopic Shoulder Surgery · NA · recruiting
NCT07334171 — Inspiratory Muscle Strength and Diaphragm Thickness in People With Shoulder Pain in Tennis Players · active not recruiting

Other Hospital for Special Surgery, New York trials

Trials by the same sponsor.

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04047446 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Hospital for Special Surgery, New York
Last refreshed: 1 August 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04047446.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT04047446

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Shoulder Pain

Other Hospital for Special Surgery, New York trials

Verify against primary sources