Liposomal Bupivacaine in Shoulder Arthroscopy

• Status: Recruiting
• Trial end date: 2028-05-21
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pennsylvania
• Treatments: Bupivacaine; Dexamethasone

Criteria

Inclusion Criteria:

• physical ASA status I-III

• age greater than 18 years

• mental competency

• ability to provide informed consent for the study.

Exclusion Criteria:

• severe pulmonary disease including chronic obstructive pulmonary disease(COPD)

• home oxygen use

• a preexisting chronic pain syndrome (defined as daily opioid intake for more than three months prior to surgery)

• allergies to any of the study medications or any of the medications in the multimodal analgesic regimen

• an inability to receive a nerve block due to anticoagulation status infection

• nerve injury

• patient refusal.