Liposomal Bupivacaine in Shoulder Arthroscopy
Public ClinicalTrials.gov record NCT04461028. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
The Effect of Liposomal Bupivacaine on the Quality of Recovery in Patients Undergoing Shoulder Arthroscopy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: The research study is being conducted to see if using the liposomal Bupivacaine for the Interscalene block will improve the patient pain control and the whole patient's experience 48 hours after surgery when compared to using the regular Marcaine (bupivacaine hydrochloride) in addition to the dexamethasone. All preoperative, surgical, post-operative care in the recovery room, and discharge instructions will be the same as any other patient undergoing this surgery. Study procedures: 1. After obtaining informed consent, an anesthesiologist will receive an envelope with result of randomization. Patients will receive a single injection interscalene nerve block prior to surgery 2. Patients will be randomized to one of two groups: * GROUP 1 liposomal Bupivacaine - will receive a 20 ml mixture of 10 ml of Liposomal Bupivacaine 1.3% and 10 ml of Bupivacaine HCl 0.5%. * GROUP 2 Bupivacaine with dexamethasone - will receive 20 ml of Bupivacaine HCl 0.5% with 4 mg of preservative-free dexamethasone. 4\. Patients will undergo general endotracheal anesthesia with inhaled anesthetic (Sevoflurane) for a goal MAC 1.0. Other than the aforementioned interscalene nerve block, patients will not receive any other local anesthetic. 5\. Patients will receive a multimodal analgesic and antiemetic regimen standardized for shoulder arthroscopies at our institution. Preoperatively, all patients will receive 300 mg of gabapentin and 1,000 mg of acetaminophen orally. Intraoperatively, patients will receive 4 mg of ondansetron and 15 mg of ketorolac intravenously. Postoperatively, patients will remain on an oral regimen of 300 mg of gabapentin three times daily for one week, and 1,000 mg of acetaminophen and 10 mg of ketorolac every 8 hours for 48 hours after surgery. 6\. Additional intraoperative or postoperative opioid analgesics will be administered as needed. Patients with a history of PONV or otherwise deemed high risk for PONV by the attending anesthesiologist will receive a scopolamine patch before induction of general anesthesia.
Study identification
- NCT ID
- NCT04461028
- Recruitment status
- Withdrawn
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 20, 2019
- Primary completion
- Jun 26, 2022
- Completion
- Jun 26, 2022
- Last update posted
- Mar 11, 2024
2019 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Penn Presbyterian Medical Center | Philadelphia | Pennsylvania | 19104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04461028, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 11, 2024 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04461028 live on ClinicalTrials.gov.