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Completed

NCT Number: NCT03663283

Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Liposomal bupivacaine

Drug

Interscalene Nerve Blocks

Bupivacaine Hydrochloride

Drug

Interscalene Nerve Blocks

Primary outcomes

  1. Patient Pain Scores

    Time frame: 72 hours post-operatively

    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.

Secondary outcomes

  1. Opioid Consumption

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

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

  2. Time to Cessation of Nerve Blockade

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

    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.

  3. Satisfaction With Pain Control Using Satisfaction Scale

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

    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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty: A Single Blinded Prospective Randomized Control Trial

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 10, 2018
Registry last updated
Feb 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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