Interscalene Block With Liposomal Bupivacaine vs. Interscalene Block With Bupivacaine and Adjuvants

Shoulder Arthroplasty Clinical Trial

Official title:

Single Injection Interscalene Brachial Plexus Nerve Block With Adjuvants vs. Liposomal Bupivacaine Interscalene Brachial Plexus Nerve Block for Total Shoulder Arthroplasty

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03845894
• Other study ID #: IRB00055981
• Status: Terminated
• Phase: Phase 4
• Start date: March 3, 2020
• Est. completion date: June 25, 2022

Study information

• Verified date: September 2022
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.

Description:

The primary objective of this clinical study is to evaluate the comparative efficacy of interscalene block (ISB) using plain bupivacaine with adjuvants vs. liposomal bupivacaine on mean postoperative pain levels in patients who have undergone a total shoulder arthroplasty within the first 48 hours. Principal Investigators hypothesize that ISB using plain bupivacaine with adjuvants will provide similar pain relief as ISB using liposomal bupivacaine.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: June 25, 2022
• Est. primary completion date: June 25, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing total shoulder arthroplasty (not a reverse)

• Age = 18 years

• Ability to understand and the willingness to sign an IRB-approved informed consent document.

• ASA patient status I-III patients

• Weight Greater than or equal to 50 kg

Exclusion Criteria:

• Contraindications to an interscalene block or phrenic blockade

• Infection at injection site

• Pre-existing neurological dysfunction affecting the operative extremity

• Chronic pain diagnosis or opioid use >40mg oxycodone daily equivalents or use of long-acting opioids

• BMI >40

• Uncontrolled diabetes (A1c >8.0)

• Concurrent painful physical condition requiring analgesic treatment (eg, NSAID or opioid) in the postsurgical period for pain not strictly related to the surgery

• Contraindications to any pain-control agents planned for surgical or postsurgical use (i.e., bupivacaine, hydromorphone, etc.)

• Patients who are wards of the state

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to bupivacaine or liposomal bupivacaine.

• Patients with moderate-severe hepatic or renal impairment

Related Conditions & MeSH terms

• Shoulder Arthroplasty

Intervention

Drug:
• Liposomal bupivacaine
Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)
• Bupivacaine with adjuvants
Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

References & Publications (5)

Hamilton TW, Athanassoglou V, Mellon S, Strickland LH, Trivella M, Murray D, Pandit HG. Liposomal bupivacaine infiltration at the surgical site for the management of postoperative pain. Cochrane Database Syst Rev. 2017 Feb 1;2(2):CD011419. doi: 10.1002/14651858.CD011419.pub2. — View Citation

Hamilton TW, Athanassoglou V, Trivella M, Strickland LH, Mellon S, Murray D, Pandit HG. Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. Cochrane Database Syst Rev. 2016 Aug 25;2016(8):CD011476. doi: 10.1002/14651858.CD011476.pub2. — View Citation

Pichler L, Poeran J, Zubizarreta N, Cozowicz C, Sun EC, Mazumdar M, Memtsoudis SG. Liposomal Bupivacaine Does Not Reduce Inpatient Opioid Prescription or Related Complications after Knee Arthroplasty: A Database Analysis. Anesthesiology. 2018 Oct;129(4):689-699. doi: 10.1097/ALN.0000000000002267. — View Citation

Rabin T. FDA In Brief: FDA approves new use of Exparel for nerve block pain relief following shoulder surgeries.

Sakamoto B, Keiser S, Meldrum R, Harker G, Freese A. Efficacy of Liposomal Bupivacaine Infiltration on the Management of Total Knee Arthroplasty. JAMA Surg. 2017 Jan 1;152(1):90-95. doi: 10.1001/jamasurg.2016.3474. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Pain Scores for the First 48 Hours	Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome.	At 48 hours postoperatively
Secondary	Postoperative Opioid Consumption for the First 48 Hours	Morphine milligram equivalents (MME) over a 48 hour period	up to 48 hours
Secondary	Satisfaction With Surgical Experience	Satisfaction scale is from 1-5, with the higher score being highest level of satisfaction	at 48 hours