Liposomal Bupivacaine Interscalene Nerve Block in Shoulder Arthroplasty

NCT03663283 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 18-005366
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arthropathy Shoulder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Opioid Consumption

  Measured at 72 hours and at 3 weeks post-operatively

• Time to Cessation of Nerve Blockade

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

• Satisfaction With Pain Control Using Satisfaction Scale

  Measured at 72 hours and at three weeks post-operatively

Study Arms (2)

Liposomal Bupivacaine

EXPERIMENTAL

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.

Drug: Liposomal Bupivacaine

Plain Bupivacaine

ACTIVE COMPARATOR

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.

Drug: Bupivacaine Hydrochloride

Interventions

Liposomal Bupivacaine DRUG

Interscalene Nerve Blocks

Liposomal Bupivacaine

Bupivacaine Hydrochloride DRUG

Interscalene Nerve Blocks

Plain Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Arizona

Phoenix, Arizona, 85054, United States

Location

Related Links

• Mayo Clinic Clinical Trials
• PubMed

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Steven J. Hattrup, M.D.
• Organization: Mayo Clinic

hattrup.steven@mayo.edu

480-301-8519

Study Officials

• Steven J Hattrup

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 10, 2018
• Study Start: October 29, 2018
• Primary Completion: February 14, 2020
• Study Completion: February 14, 2020
• Last Updated: February 21, 2021
• Results First Posted: February 21, 2021

Record last verified: 2021-02

Locations

US (1)