LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

September 11, 2023 updated by: Kevin Finkel, Hartford Hospital

LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus

This will be a single-center, prospective, randomized controlled cross-sectional study comparing interscalene brachial plexus block with liposomal bupivacaine versus bupivacaine with epinephrine and PF dexamethasone in patients undergoing primary shoulder arthroplasty. Primary endpoint will be total opioid consumption in the first three post-operative days.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • The Bone and Joint Institute at Hartford Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient age >18 years;
  • Lack of language barrier;
  • Informed consent obtained;
  • Presenting for primary total shoulder arthroplasty (TSA), both anatomic and reverse, by a specialty-trained surgeon;
  • American Society of Anesthesiology (ASA) physical status score I- III

Exclusion Criteria:

  • Presence of a language barrier;
  • Inability to complete telephone and/or paper questionnaire;
  • Lack of consent;
  • Allergy to local anesthetic;
  • Chronic pain syndrome and/or preoperative opioid use > 50 MME per day (including extended-release formulations and methadone);
  • Preoperative consultation to chronic pain service;
  • History of (<3 months) or current substance abuse, including any illicit drugs or excessive alcohol consumption as defined by the Office of Disease Prevention and Health Promotion (4 or more drinks per day or 8 or more drinks per week for women and 5 or more drinks per day or 15 or more drinks per week for men);
  • Baseline peripheral neuropathy of the brachial plexus;
  • Contraindication to receiving single shot peripheral nerve blockade; including antithrombotic medications as per most recent American Society of Regional - - -Anesthesiology (ASRA) guidelines 17 , coagulopathy or coagulation disorder, or infection at injection site;
  • Severe chronic obstructive pulmonary disease (COPD) or other significant pulmonary disease where interscalene nerve block would be contraindicated due to concern for respiratory failure from phrenic nerve palsy;
  • Weight < 45 kg, given concern for local anesthetic toxicity at dosages given for the study; ASA score IV-V;
  • Revision arthroplasty;
  • Anatomic abnormality that limits or prevents the patient from receiving an interscalene nerve block;
  • Pregnant, nursing, or planning to become pregnant during the study or within 1 month after the shoulder replacement surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liposomal Bupivacaine 1.3%
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
Drug: Liposomal Bupivicaine 1.3%
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
Active Comparator: Bupivacaine 0.5% with Adjuncts
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Drug: Bupivacaine 0.5%
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Other Names:
  • epinephrine
  • dexamethasone preservative-free

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Opioid Consumption
Time Frame: Up to 120 postoperative hours
Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)
Up to 120 postoperative hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Opioid Medication
Time Frame: from the time of the block injection until discharge, assessed up to 72 postoperative hours.
From block time to the first dose of opioids given, measured in hours.
from the time of the block injection until discharge, assessed up to 72 postoperative hours.
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
Time Frame: 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60
Pain assessment is categorized as minimum, maximum, and average pain scores reported by patients using questions from the Modified Brief Pain Inventory-short form (MBPI-SF) during the following intervals; PACU-24, 24-48, 48-72, and 72-96 postoperative hours, and at day 60. This form collected minimum, maximum, and average on a numeric pain scale (0-10) where 0 is no pain and 10 is the worst pain.
24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60
Hospital Length-of-stay
Time Frame: From the date of admission until discharge, assessed up to 72 hours.
From the date and time of admission to the date and time of discharge, Measured in hours.
From the date of admission until discharge, assessed up to 72 hours.
Assessment of Patient Overall Satisfaction With Pain Control
Time Frame: POD4 - 60 days
Patient overall satisfaction with pain control was assessed two times; on the fourth and the 60th postoperative days. It was assessed using a numeric scale (0-10) where 0 is very dissatisfied while 10 is extremely satisfied. The results indicated only the percentage of participants who reported a 10/10 satisfaction rate.
POD4 - 60 days
Incidence of Distress From Block Numbness
Time Frame: At PACU and Postoperative day 2
On a distress scale of (0 -10) with 0 = not at all and 10 = very much distressed, the scores were gathered and the results are grouped to show the percentage of either the presence of distress (any positive score) or no distress, assessed at two times; at the PACU and the second postoperative day.
At PACU and Postoperative day 2
Duration of Sensory Nerve Block
Time Frame: Day 1, after Day 1 (day 2 to 60), and at postoperative day 60
Using the sensory assessment test, the results show the percentage of participants who had the return of first sensation and full sensation either on Day 1, after Day 1 (day 2 to 60), and at postoperative day 60.
Day 1, after Day 1 (day 2 to 60), and at postoperative day 60
Day of the Final Opioids Used
Time Frame: 0-96 postoperative hours
The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours.
0-96 postoperative hours
Motor Recovery
Time Frame: PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.

The Motor function was assessed by shoulder abduction and elbow flexion using the Oxford scale of muscle strength grading (Muscle Grading Scores 0-5):

0= No detectable muscle contraction (visible or palpation)

  1. Detectable contraction (visible or palpation), but no movement achieved
  2. Limb movement achieved, but unable to move against gravity
  3. Limb movement against the resistance of gravity
  4. Limb movement against gravity and external resistance
  5. Normal strength

The results were grouped to show the return of any movement at the PACU, Day 1, after Day 1 (day2-60), and on day 60. And the return of full movement between day 2 and 60 and at day 60, in addition to the missing data.
PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Amount of Opioid Consumed During the Indicated Time Periods
Time Frame: 0-24, 24-48, 48-72, and 72-120 postoperative hours.
Opioid use was calculated using the Morphine MilliEquevalent per day, this was assessed daily during the postoperative period, 0-24, 24-48, 48-72, and 72-120 postoperative hours.
0-24, 24-48, 48-72, and 72-120 postoperative hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hartford Hospital

Investigators

  • Principal Investigator: Kevin Finkel, MD, Hartford Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2019

Primary Completion (Actual)

January 11, 2022

Study Completion (Actual)

March 8, 2022

Study Registration Dates

First Submitted

March 21, 2019

First Submitted That Met QC Criteria

March 21, 2019

First Posted (Actual)

March 25, 2019

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 11, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHC-2018-0231

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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