Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty

Mayo Clinic104 enrolled

Overview

The objective of this study is to determine if peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine will prolong the duration of block, improve pain scores, and decrease opioid utilization in the post-operative period when compared to peripheral nerve block with standard bupivacaine alone.

This is a prospective, single-blinded randomized clinical trial comparing outcomes in patients undergoing total shoulder arthroplasty (anatomic and reverse) who receive a peripheral nerve block with liposomal bupivacaine in combination with standard bupivacaine versus standard bupivacaine alone. Once consent is obtained, baseline characteristics will be recorded and patients will be randomized to intervention or control. Following surgery, patients will be followed until their 3-week post-operative visit. The primary outcome measure will be the mean difference in patient pain scores over the first 72 hours post-operatively between two groups. Secondary outcomes will include: (1) Total opioid consumption (as measured utilizing morphine intravenous equivalents) in first 72 hours and at 3 weeks (2) Patient perceived duration of block determined as the time patient perceives complete resolution of block (3) Patient satisfaction with pain control at 72 hours, 3 weeks post-operatively and patient reported outcome measures (SANE, SST, ASES, VR-12) at 3 weeks post-operatively.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

104

Conditions

Arthropathy Shoulder

Interventions

Liposomal BupivacaineDRUG

Interscalene Nerve Blocks

Bupivacaine HydrochlorideDRUG

Interscalene Nerve Blocks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria * All adult patients (\>18 years of age) * Patients undergoing standard or reverse total shoulder arthroplasty for the primary diagnoses of glenohumeral arthritis or cuff tear arthropathy * Cognitively intact with the ability to give informed consent as outlined by our institutional review board. * Patients must be capable of participating in the post-operative electronic survey and / or able to maintain a written diary of events Exclusion Criteria * Non-elective cases * Infection, tumor, trauma * Weight \< 50 kg * Patients with any contraindications to regional anesthesia including allergy or hypersensitivity to amide-type local anesthetics * Patients with allergy to any component of medication regimen e.g. amide- type local anesthetics, oxycodone, hydromorphone, fentanyl * Chronic pain patients with history of chronic opioid use (defined as 20 mg morphine equivalent / day for greater than 30 days pre-operatively * Concurrent painful physical condition that may require analgesic treatment that is not related to the shoulder surgery (chronic peripheral neuropathy, radiculopathy, or other neurologic disorder) * Severe hepatic disease defined by clinical evidence of liver disease with abnormal liver function tests. * Pregnancy * Respiratory disease that contraindicates interscalene nerve block (elevated contralateral hemidiaphragm, contralateral pneumonectomy, or severe COPD with FEV1 \< 50% predicted, and 02 dependence)

Locations (1)

Mayo Clinic in Arizona

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Patient Pain Scores

Patient pain scores over the first 72 hours post-operatively as measured by the Visual Analogue Scale where Zero represents no pain and ten represents severe pain.

Time frame: 72 hours post-operatively

Secondary Outcomes

Opioid Consumption

Total opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks

Time frame: Measured at 72 hours and at 3 weeks post-operatively

Time to Cessation of Nerve Blockade

Measured by the number of subjects who reported cessation of nerve blockade as the first reported postoperative pain score of 3 or greater at the surgical site.

Time frame: 4, 8, 12, 16, 20, 24, and 28 hours post-operatively

Satisfaction With Pain Control Using Satisfaction Scale

Patient satisfaction with pain control at 72 hours post-operatively and three weeks post operatively using Patient Satisfaction with Pain Management Pain Scale where Zero represents unsatisfactory pain management and ten represents perfect pain management.

Time frame: Measured at 72 hours and at three weeks post-operatively

Data from ClinicalTrials.gov

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