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CompletedNCT03887650Updated Sep 15, 2023Results posted

LIBERATE - LIposomal Bupivacaine vERsus Adjuncts in Total shouldErs

A Phase 4 interventional study of Liposomal Bupivicaine 1.3% and Bupivacaine 0.5% in Post-operative Pain, Total Shoulder Arthroplasty and Osteoarthritis of the Shoulder, sponsored by Hartford Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2023-09-15.

Sponsored by Hartford Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Post-operative Pain
  • Total Shoulder Arthroplasty
  • Osteoarthritis of the Shoulder
  • Pain Management

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Keywords

  • Brachial Plexus
  • Liposomal Bupivacaine
  • Dexamethasone
  • Interscalene
  • Bupivacaine
  • Shoulder Arthroplasty
  • Regional anesthesia
  • Exparel
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's enrollment of 90 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Hartford Hospital is the lead sponsor of 101 studies on the registry; 19 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
90 participants (actual)

Study arms

  • 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%

  • 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%

Interventions

  • DrugLiposomal 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

  • DrugBupivacaine 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

    Also known as: epinephrine, dexamethasone preservative-free

06

What researchers measure

Primary outcomes

  1. Total Opioid Consumption

    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 outcomes

  1. Time to First Opioid Medication

    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.

  2. 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.

    Time frame: 24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60

  3. Hospital Length-of-stay

    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.

  4. 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.

    Time frame: POD4 - 60 days

  5. 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.

    Time frame: At PACU and Postoperative day 2

  6. 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.

    Time frame: Day 1, after Day 1 (day 2 to 60), and at postoperative day 60

  7. 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.

    Time frame: 0-96 postoperative hours

  8. 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) 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.

    Time frame: PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.

Other outcomes

  1. Total Amount of Opioid Consumed During the Indicated Time Periods

    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.

07

Results

Posted Sep 15, 2023
Limitations and caveats
Opioid consumption was subjected to patient recall and reporting bias. Patients were advised by surgery clinics to limit opioid intake postoperatively, which might indirectly limit opioid use and made it more difficult to show a difference. The study was double-blinded, the anesthesiologists who performed the block, were unblinded due to the difference in the physical appearance of the study drugs.

Participant flow

Preoperative-48 Hours Postoperative
Participant flow — Preoperative-48 Hours Postoperative
MilestoneLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
Started4545
Completed4544
Not completed01
Withdrew: Withdrawal by subject01
48-96 Hours Postoperative
Participant flow — 48-96 Hours Postoperative
MilestoneLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
Started4544
Completed4542
Not completed02
Withdrew: Withdrawal by subject02
60 Postoperative Days
Participant flow — 60 Postoperative Days
MilestoneLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
Started4542
Completed4442
Not completed10
Withdrew: Withdrawal by subject10

Outcome measures

PrimaryTotal Opioid Consumption

Total opioids used for the first 120 postoperative hours after TSA, standardized to morphine milligram equivalents (MMEs)

Time frame:
Up to 120 postoperative hours
Reported as:
Median · MME
Total Opioid Consumption
MMELiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
Total Opioid Consumption71.25 (43.00 to 120.00)90.30 (57.37 to 133.43)
Statistical analysis
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = 0.127
SecondaryTime to First Opioid Medication

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.
Reported as:
Median · hours
Time to First Opioid Medication
hoursLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
Time to First Opioid Medication10.5667 (5.800 to 20.850)12.025 (4.404 to 21.983)
Statistical analysis
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .975
SecondaryPain 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.

Time frame:
24, 24-48, 48-72, and 72-96 hours postoperation, and at day 60
Reported as:
Median · units on a scale 0-10
Pain Assessment at Post Anesthesia Care Unit (PACU)-96 Postoperative Hours
units on a scale 0-10Liposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
PACU0.00 (0.00 to 1.00)0.00 (0.00 to 1.50)
PACU-24 hours Minimum0.00 (0.00 to 1.00)0.00 (0.00 to 0.00)
PACU-24 hours Maximum2.00 (0.00 to 4.50)1.00 (0.00 to 4.50)
PACU-24 hours Average1.00 (0.00 to 2.00)0.00 (0.00 to 3.50)
24-48 hours Minimum0.00 (0.00 to 2.00)2.00 (0.00 to 3.75)
24-48 hours Maximum4.50 (1.00 to 6.00)7.00 (5.00 to 8.00)
24-48 hours Average2.00 (0.00 to 3.75)4.00 (3.00 to 5.00)
48-72 hours Minimum1.00 (0.00 to 2.00)2.00 (1.00 to 3.00)
48-72 hours Maximum4.00 (1.75 to 6.00)6.00 (4.50 to 7.00)
48-72 hours Average2.00 (1.00 to 3.25)3.00 (2.00 to 5.00)
72-96 hours Minimum0.50 (0.00 to 2.00)2.00 (0.00 to 2.00)
72-96 hours Maximum4.00 (1.75 to 5.25)5.00 (4.00 to 7.0)
72-96 hours Average2.00 (1.00 to 3.00)3.00 (2.00 to 4.00)
60 days postoperative Maximum5.00 (2.00 to 6.00)6.00 (4.25 to 8.00)
60 days postoperative Average1.00 (0.25 to 3.00)2.00 (1.00 to 3.00)
60 days postoperative Minimum0.00 (0.00 to 0.75)0.00 (0.00 to 1.00)
Statistical analysis
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .852 (PACU pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .661 (For (PACU-24) minimum pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .747 (For (PACU-24 hr.) maximum pain score)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .604 (For (PACU-24 hr) average pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .002 ((24-48 hr) minimum pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = <0.01 (For (24-48 hr) maximum pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = <0.01 (For (24-48 hr) average pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .011 ((48-72 hr) minimum pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .001 ((48-72 hr) maximum pain scores)
  • Liposomal Bupivacaine 1.3% · Wilcoxon (Mann-Whitney) · p = .003 ((48-72 hr) average pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .230 (For (72-96 hr) minimum pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .007 (For (72-96 hr) maximum pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .011 (For (72-96 hr) average pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .378 (For (postoperative day 60) minimum pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .001 (For (postoperative day 60) maximum pain scores)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .403 (For (postoperative day 60) average pain scores)
SecondaryHospital Length-of-stay

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.
Reported as:
Median · hour
Hospital Length-of-stay
hourLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
Hospital Length-of-stay31.05 (29.67 to 32.53)31.63 (30.63 to 36.58)
Statistical analysis
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .112
SecondaryAssessment 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.

Time frame:
POD4 - 60 days
Reported as:
Count of participants · Participants
Assessment of Patient Overall Satisfaction With Pain Control
ParticipantsLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
POD4 — 10/103224
POD4 — below 10917
POD4 — Missing data41
POD60 — 10/102728
POD60 — below 101213
POD60 — Missing data51
Statistical analysis
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Fisher Exact · p = 0.096 (P-Value for POD4)Fisher's Exact for POD4
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Chi-squared · p = 1.0 (For POD60)Chi-squared for POD60
SecondaryIncidence 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.

Time frame:
At PACU and Postoperative day 2
Reported as:
Count of participants · Participants
Incidence of Distress From Block Numbness
ParticipantsLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
PACU distress — No distress3131
PACU distress — any distress1414
PACU distress — Missing data00
POD2 Distress — No distress3231
POD2 Distress — any distress1212
POD2 Distress — Missing data12
Statistical analysis
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Chi-squared · p = 1.0 (Any distress on PACU)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Chi-squared · p = .947 (Postoperative day 2)
SecondaryDuration 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.

Time frame:
Day 1, after Day 1 (day 2 to 60), and at postoperative day 60
Reported as:
Count of participants · Participants
Duration of Sensory Nerve Block
ParticipantsLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
Full sensation — Returned on day 1 after the block1111
Full sensation — Returned on day 2-602727
Full sensation — Not by day 6002
Full sensation — Missing data75
First sensation — Returned on day 1 after the block3533
First sensation — Returned on day 2-60910
First sensation — Not by day 6000
First sensation — Missing data12
Statistical analysis
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Fishers Freeman Halton · p = .441 (Full sensation)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Fishers Freeman Halton · p = .691 (First sensation)
SecondaryDay 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.

Time frame:
0-96 postoperative hours
Reported as:
Median · day
Day of the Final Opioids Used
dayLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
Day of the Final Opioids Used4 (1.5 to 4)4 (1 to 4)
Statistical analysis
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .876
SecondaryMotor 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) 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.

Time frame:
PACU, Day 1, after Day 1 (day 2 and 60), and at postoperative day 60.
Reported as:
Count of participants · Participants
Motor Recovery
ParticipantsLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
Any movement in PACU111
Any movement in day143
Any movement after day13829
Any movement missing data22
Return of full movement day 2-603231
Not yet by day 6036
Return of full movement missing data108
Statistical analysis
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Fisher' Freeman Halton · p = .011 (Any movement)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Fishers Freeman Halton · p = .536 (Full movement)
Other pre-specifiedTotal Amount of Opioid Consumed During the Indicated Time Periods

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.
Reported as:
Median · MME/day
Total Amount of Opioid Consumed During the Indicated Time Periods
MME/dayLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
0-24 hours25.00 (25.00 to 39.37)25.00 (25.00 to 37.50)
24-48 hours16.00 (0.00 to 38.75)23.25 (9.75 to 39.37)
48-72 hours2.00 (0.00 to 8.00)5.00 (0.00 to 15.00)
72-120 hours10.00 (0.00 to 27.00)15.00 (0.00 to 37.50)
Statistical analysis
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .648 (MME 0-24)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .285 (MME24-48)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .122 (MME48-72)
  • Liposomal Bupivacaine 1.3% vs Bupivacaine 0.5% With Adjuncts · Wilcoxon (Mann-Whitney) · p = .367 (MME 72-120)

Adverse events

Collected over Adverse events were collected up to 60 postoperative days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Liposomal Bupivacaine 1.3%0/45 (0%)0/45 (0%)18/45 (40%)
Bupivacaine 0.5% With Adjuncts0/45 (0%)0/45 (0%)21/45 (46.7%)
Most frequent other events
Most frequent other events
EventLiposomal Bupivacaine 1.3%Bupivacaine 0.5% With Adjuncts
Nausea and vomitingGeneral disorders8/4516/45
BruisingSurgical and medical procedures5/453/45
RashSkin and subcutaneous tissue disorders1/451/45
SwellingSurgical and medical procedures1/450/45
InflammationSurgical and medical procedures1/450/45
Ringing in earsEar and labyrinth disorders1/451/45
Numbness and tinglingNervous system disorders1/450/45

Baseline characteristics

Age, Continuous
Age, Continuous(years)Liposomal Bupivacaine 1.3%Bupivacaine 0.5% With AdjunctsTotal
Median72 (66.5 to 77.0)73 (66.5 to 78.0)73 (66.75 to 78)
Sex: Female, Male
Sex: Female, Male(Participants)Liposomal Bupivacaine 1.3%Bupivacaine 0.5% With AdjunctsTotal
Female222345
Male232245
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Liposomal Bupivacaine 1.3%Bupivacaine 0.5% With AdjunctsTotal
Hispanic or Latino112
Not Hispanic or Latino444488
Unknown or Not Reported000
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Liposomal Bupivacaine 1.3%Bupivacaine 0.5% With AdjunctsTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American022
White444286
More than one race000
Unknown or Not Reported112
Body Mass Index (BMI)
Body Mass Index (BMI)(kg/m^2)Liposomal Bupivacaine 1.3%Bupivacaine 0.5% With AdjunctsTotal
Median31.30 (27.25 to 33.65)31.60 (27.00 to 35.850)31.35 (27.25 to 34.23)
ASA Physical Status Classification
ASA Physical Status Classification(units on a scale)Liposomal Bupivacaine 1.3%Bupivacaine 0.5% With AdjunctsTotal
Median2 (2 to 3)2 (2 to 3)2 (2 to 3)
Preoperative shoulder pain
Preoperative shoulder pain(Participants)Liposomal Bupivacaine 1.3%Bupivacaine 0.5% With AdjunctsTotal
None121123
Mild162036
Moderate15722
Severe279
Comorbidities
Comorbidities(Participants)Liposomal Bupivacaine 1.3%Bupivacaine 0.5% With AdjunctsTotal
Diabetes Miletus : yes6915
Diabetes Miletus : no393675
Hyperlipidemia : yes262551
Hyperlipidemia : no192039
Hypertension : yes292554
Hypertension : no162036
COPD : yes022
COPD : no454388
RA : yes033
RA : no454287
Opioids at home : yes369
Opioids at home : no423981
08

Study locations

1 site
  • The Bone and Joint Institute at Hartford Hospital
    Hartford, Connecticut 06102, United States
09

References and documents

Publications

  • Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272. doi: 10.1001/jamasurg.2018.5476. PubMed 28403427 ↗
  • Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38. PubMed 20009936 ↗
  • Movafegh A, Razazian M, Hajimaohamadi F, Meysamie A. Dexamethasone added to lidocaine prolongs axillary brachial plexus blockade. Anesth Analg. 2006 Jan;102(1):263-7. doi: 10.1213/01.ane.0000189055.06729.0a. PubMed 16368840 ↗
  • Parrington SJ, O'Donnell D, Chan VW, Brown-Shreves D, Subramanyam R, Qu M, Brull R. Dexamethasone added to mepivacaine prolongs the duration of analgesia after supraclavicular brachial plexus blockade. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):422-6. doi: 10.1097/AAP.0b013e3181e85eb9. PubMed 20814282 ↗
  • Rasmussen SB, Saied NN, Bowens C Jr, Mercaldo ND, Schildcrout JS, Malchow RJ. Duration of upper and lower extremity peripheral nerve blockade is prolonged with dexamethasone when added to ropivacaine: a retrospective database analysis. Pain Med. 2013 Aug;14(8):1239-47. doi: 10.1111/pme.12150. Epub 2013 Jun 11. PubMed 23755801 ↗
  • McLaughlin DC, Cheah JW, Aleshi P, Zhang AL, Ma CB, Feeley BT. Multimodal analgesia decreases opioid consumption after shoulder arthroplasty: a prospective cohort study. J Shoulder Elbow Surg. 2018 Apr;27(4):686-691. doi: 10.1016/j.jse.2017.11.015. Epub 2018 Jan 3. PubMed 29305103 ↗
  • Candiotti K. Liposomal bupivacaine: an innovative nonopioid local analgesic for the management of postsurgical pain. Pharmacotherapy. 2012 Sep;32(9 Suppl):19S-26S. doi: 10.1002/j.1875-9114.2012.01183.x. PubMed 22956491 ↗
  • Abildgaard JT, Lonergan KT, Tolan SJ, Kissenberth MJ, Hawkins RJ, Washburn R 3rd, Adams KJ, Long CD, Shealy EC, Motley JR, Tokish JM. Liposomal bupivacaine versus indwelling interscalene nerve block for postoperative pain control in shoulder arthroplasty: a prospective randomized controlled trial. J Shoulder Elbow Surg. 2017 Jul;26(7):1175-1181. doi: 10.1016/j.jse.2017.03.012. Epub 2017 May 4. PubMed 28479257 ↗
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  • Wang K, Zhang HX. Liposomal bupivacaine versus interscalene nerve block for pain control after total shoulder arthroplasty: A systematic review and meta-analysis. Int J Surg. 2017 Oct;46:61-70. doi: 10.1016/j.ijsu.2017.08.569. Epub 2017 Aug 24. PubMed 28843463 ↗
  • Schroer WC, Diesfeld PG, LeMarr AR, Morton DJ, Reedy ME. Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial. J Arthroplasty. 2015 Sep;30(9 Suppl):64-7. doi: 10.1016/j.arth.2015.01.059. Epub 2015 Jun 3. PubMed 26117072 ↗
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Study documents

  • Protocol and statistical analysis plan · Sep 2, 2022
  • Informed consent form · Sep 8, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03887650
Lead sponsor
Hartford Hospital
Responsible party
Kevin Finkel (Principal Investigator, Hartford Hospital) — Principal investigator
First posted
Mar 25, 2019
Start date
Mar 11, 2019
Primary completion
Jan 11, 2022
Completion
Mar 8, 2022
Results posted
Sep 15, 2023
Last update
Sep 15, 2023

Study contacts

Kevin Finkel, MD
principal investigator · Hartford Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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