Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03728946
• Date of registration: 31/10/2018
• Prospective Registration: Yes
• Primary sponsor: Orthopaedic & Neurosurgery Specialists
• Public title: Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery
• Scientific title: Interscalene Block With and Without Liposomal Bupivacaine in Shoulder Surgery
• Date of first enrolment: November 21, 2018
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03728946
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Participant).
• Phase: N/A

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Patients over 18 undergoing rotator cuff repair or total shoulder arthroplasty

Exclusion Criteria:

- Pregnant

- Documented drug of alcohol abuse

- Active narcotic use prior to surgery

- Neurological deficit

- Allergy to amide anesthetics

- Not cleared by primary care physician

- Hydrocodone or oxycodone intolerance

- Enrollment in another clinical trial or past cognitive or mental health status that
interferes with study



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Postoperative Pain

Rotator Cuff Tear

Intervention(s)

Drug: Liposomal Bupivacaine

Primary Outcome(s)

Opiate Consumption [Time Frame: Post-operative days 1-14]

Secondary Outcome(s)

VAS Pain Scores [Time Frame: Post operative days 1-14]

Likert Pain Satisfaction Rating [Time Frame: Post operative days 1-14]

Secondary ID(s)

2018016

Source(s) of Monetary Support

Please refer to primary and secondary sponsors