Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty

Arthropathy Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663283
• Other study ID #: 18-005366
• Status: Completed
• Phase: Phase 4
• Start date: October 29, 2018
• Est. completion date: February 14, 2020

Study information

• Verified date: February 2021
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: February 14, 2020
• Est. primary completion date: February 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthropathy Shoulder
• Joint Diseases

Intervention

Drug:
• Liposomal Bupivacaine
Interscalene Nerve Blocks
• Bupivacaine Hydrochloride
Interscalene Nerve Blocks

Locations

Country	Name	City	State
United States	Mayo Clinic in Arizona	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	72 hours post-operatively
Secondary	Opioid Consumption	Total opioid consumption as measured by morphine milligram equivalent (MME) in first 72 hours and at 3 weeks	Measured at 72 hours and at 3 weeks post-operatively
Secondary	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.	4, 8, 12, 16, 20, 24, and 28 hours post-operatively
Secondary	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.	Measured at 72 hours and at three weeks post-operatively

External Links

•   Mayo Clinic Clinical Trials
•   PubMed