Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-29

Study Completion Date

2020-02-14

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Arthropathy Shoulder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

The pharmacist will prepare, and dispense the medication sequentially. Medication syringes will be blinded utilizing black tape. Patients, care team in recovery, study team members collecting and recording data, and statisticians will be blinded to randomization assignment. All patients will be documented in EMR as receiving liposomal bupivacaine to ensure the blind is maintained and to ensure that safety features in the EMR for all patients receiving liposomal bupivacaine are activated. Further, all additional standard precautionary measures (e.g. wrist band) will be similarly implemented for both patient groups.

Study Groups

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Liposomal Bupivacaine

Administered utilizing ultrasound guidance by an anesthesiologist. Study patients will receive 10ml (133 mg) of liposomal bupivacaine mixed with 7.5ml of 0.5% plain bupivacaine and 7.5ml of 0.25% bupivacaine. Further, 8 mg (2 ml) IV dexamethasone will be administered concomitantly at the time of the block.

Group Type EXPERIMENTAL

Liposomal Bupivacaine

Intervention Type DRUG

Interscalene Nerve Blocks

Plain Bupivacaine

Peripheral nerve blocks will be performed with ultrasound guidance by an anesthesiologist. Standard bupivacaine hydrochloride will be utilized. 25 ml of 0.5% bupivacaine for peripheral nerve block will be utilized. Further, 8 mg (2 ml) IV dexamethasone will be administered concomitantly at the time of the block.

Group Type ACTIVE_COMPARATOR

Bupivacaine Hydrochloride

Intervention Type DRUG

Interscalene Nerve Blocks

Interventions

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Liposomal Bupivacaine

Interscalene Nerve Blocks

Intervention Type DRUG

Bupivacaine Hydrochloride

Interscalene Nerve Blocks

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No