Back to resultsLIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
Primary Purpose
Post-operative Pain, Total Shoulder Arthroplasty, Osteoarthritis of the Shoulder
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Liposomal Bupivicaine 1.3%
Bupivacaine 0.5%
Sponsored by
About this trial
This is an interventional treatment trial for Post-operative Pain focused on measuring Brachial Plexus, Liposomal Bupivacaine, Dexamethasone, Interscalene, Bupivacaine, Shoulder Arthroplasty, Regional anesthesia, Exparel
Eligibility Criteria
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
Sites / Locations
- The Bone and Joint Institute at Hartford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Liposomal Bupivacaine 1.3%
Bupivacaine 0.5% with Adjuncts
Arm Description
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Outcomes
Primary Outcome Measures
Total Opioid Consumption
Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)
Secondary Outcome Measures
Time to First Opioid Medication
From block time to the first dose of opioids given, measured in hours.
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
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.
Hospital Length-of-stay
From the date and time of admission to the date and time of discharge, Measured in hours.
Assessment of Patient Overall Satisfaction With Pain Control
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.
Incidence of Distress From Block Numbness
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.
Duration of Sensory Nerve Block
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 of the Final Opioids Used
The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours.
Motor Recovery
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)
Detectable contraction (visible or palpation), but no movement achieved
Limb movement achieved, but unable to move against gravity
Limb movement against the resistance of gravity
Limb movement against gravity and external resistance
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03887650
Brief Title
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
Official Title
LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs: A Randomized Controlled Trial of Injection at the Brachial Plexus
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2019 (Actual)
Primary Completion Date
January 11, 2022 (Actual)
Study Completion Date
March 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hartford Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-operative Pain, Total Shoulder Arthroplasty, Osteoarthritis of the Shoulder, Pain Management
Keywords
Brachial Plexus, Liposomal Bupivacaine, Dexamethasone, Interscalene, Bupivacaine, Shoulder Arthroplasty, Regional anesthesia, Exparel
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
single-center, prospective, randomized controlled cross-sectional study
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Liposomal Bupivacaine 1.3%
Arm Type
Experimental
Arm Description
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
Arm Title
Bupivacaine 0.5% with Adjuncts
Arm Type
Active Comparator
Arm Description
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Intervention Type
Drug
Intervention Name(s)
Liposomal Bupivicaine 1.3%
Intervention Description
10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
Intervention Type
Drug
Intervention Name(s)
Bupivacaine 0.5%
Other Intervention Name(s)
epinephrine, dexamethasone preservative-free
Intervention Description
20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
Primary Outcome Measure Information:
Title
Total Opioid Consumption
Description
Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)
Time Frame
Up to 120 postoperative hours
Secondary Outcome Measure Information:
Title
Time to First Opioid Medication
Description
From block time to the first dose of opioids given, measured in hours.
Time Frame
from the time of the block injection until discharge, assessed up to 72 postoperative hours.
Title
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
Description
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.
Time Frame
24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60
Title
Hospital Length-of-stay
Description
From the date and time of admission to the date and time of discharge, Measured in hours.
Time Frame
From the date of admission until discharge, assessed up to 72 hours.
Title
Assessment of Patient Overall Satisfaction With Pain Control
Description
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.
Time Frame
POD4 - 60 days
Title
Incidence of Distress From Block Numbness
Description
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.
Time Frame
At PACU and Postoperative day 2
Title
Duration of Sensory Nerve Block
Description
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.
Time Frame
Day 1, after Day 1 (day 2 to 60), and at postoperative day 60
Title
Day of the Final Opioids Used
Description
The postoperative day that patients in each group took their last opioid, from the end of surgery up to 96 postoperative hours.
Time Frame
0-96 postoperative hours
Title
Motor Recovery
Description
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)
Detectable contraction (visible or palpation), but no movement achieved
Limb movement achieved, but unable to move against gravity
Limb movement against the resistance of gravity
Limb movement against gravity and external resistance
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.
Time Frame
PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.
Other Pre-specified Outcome Measures:
Title
Total Amount of Opioid Consumed During the Indicated Time Periods
Description
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.
Time Frame
0-24, 24-48, 48-72, and 72-120 postoperative hours.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin Finkel, MD
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Bone and Joint Institute at Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06102
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs
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