Phase 4
Completed N=112
Liposomal Bupivacaine vs Dexamethasone ISB
Source: ClinicalTrials.gov NCT04047446 ↗Enrolled (actual)
112
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcomePrimary: Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours — 2.4; 3.4 score on a scale
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours |
2.4; 3.4 | — |
| SECONDARY Numerical Rating Scale (NRS) Pain at Rest |
1.3; 0.9; 2.1; 3.0; 2.5; 4.1 | — |
| SECONDARY Numerical Rating Scale (NRS) Pain With Movement |
8.9; 9.98; 4.0; 4.3; 4.1; 5.6 | — |
| SECONDARY Opioid Consumption |
1.8; 1.7; 4.8; 8.1; 12.3; 18.2 | — |
| SECONDARY Patient Satisfaction With Pain Management: Scale |
9.4; 9.8; 9.3; 9.2; 8.9; 8.6 | — |
| SECONDARY Brief Pain Inventory Short-form |
1.2; 0.6; 1.4; 1.8; 2.4; 3.6 | — |
| SECONDARY Duration of Analgesic Block |
26; 27 | — |
| SECONDARY Sensory Resolution |
27; 31 | — |
| SECONDARY Motor Block Resolution |
27; 27 | — |
| SECONDARY Time to Readiness for Discharge |
90; 90 | — |
| SECONDARY Postanesthesia Care Unit Length of Stay |
163.5; 163 | — |
Eligibility Criteria
Inclusion Criteria
- ASA I-III
- Age 18 years or older
- Scheduled for elective outpatient arthroscopic shoulder surgery
Exclusion Criteria
- 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
- 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
Data sourced from ClinicalTrials.gov (NCT04047446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.