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

Phase 4

Terminated

• Conditions: Shoulder Arthroplasty
• Interventions: Drug: Liposomal bupivacaine; Drug: Bupivacaine with adjuvants

• Registration Number: NCT03845894
• Lead Sponsor: Wake Forest University Health Sciences

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-01-22
• Study First Submitted QC: 2019-02-18
• Study First Posted: 2019-02-19
• Study Start: 2020-03-03
• Primary Completion: 2022-06-25
• Study Completion: 2022-06-25
• Status Verified: 2022-09
• Results First Submitted: 2023-09-25
• Results First Submitted QC: 2023-11-10
• Last Update Submitted: 2023-11-10
• Results First Posted: 2023-11-13
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 25

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposomal Bupivacaine Interscalene brachial plexus (ISB)	Liposomal bupivacaine	-
Bupivacaine with adjuvants ISB	Bupivacaine with adjuvants	-

Primary Outcome Measures

Name	Time	Method
Average Pain Scores for the First 48 Hours	At 48 hours postoperatively	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.

Secondary Outcome Measures

Name	Time	Method
Postoperative Opioid Consumption for the First 48 Hours	up to 48 hours	Morphine milligram equivalents (MME) over a 48 hour period
Satisfaction With Surgical Experience	at 48 hours	Satisfaction scale is from 1-5, with the higher score being highest level of satisfaction

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States