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Liposomal Bupivacaine vs Dexamethasone ISB

Prolonging the Interscalene Brachial Plexus Block by Adding Liposomal Bupivacaine or Preservative Free Dexamethasone to Bupivacaine: a Non-inferiority Trial

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04047446
Enrollment
112
Registered
2019-08-06
Start date
2019-07-11
Completion date
2021-03-19
Last updated
2022-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Brief summary

In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.

Interventions

DRUGExparel 133 MG Per 10 ML Injection

10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)

DRUGDexamethasone

15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected

Sponsors

Hospital for Special Surgery, New York
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* ASA I-III * Age 18 years or older * Scheduled for elective outpatient arthroscopic shoulder surgery

Exclusion criteria

* History of allergy to local anesthetic, or one of the study medications * Pre-existing neurological deficits * Psychiatric or cognitive disorders that prohibit patients from following study protocol * History of drug or alcohol abuse * Chronic opioid use (longer than 3 months) * Chronic pain syndromes * Infection at the site of injection * Patients with severe pulmonary disease * Herniated cervical disc, cervical myelopathy * Contraindication for general anesthesia and/or interscalene nerve block * Pregnancy * Open shoulder arthrotomies. * Non English speakers

Design outcomes

Primary

MeasureTime frameDescription
Numerical Rating Scale (NRS) Pain at Rest Over 72 HoursFirst 72 hours painNRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.

Secondary

MeasureTime frameDescription
Numerical Rating Scale (NRS) Pain With MovementPostanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome.
Opioid ConsumptionPostanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7Opioid consumption, measured in oral morphine equivalents
Patient Satisfaction With Pain Management: ScalePostanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction
Brief Pain Inventory Short-formPostanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life.
Numerical Rating Scale (NRS) Pain at RestPostanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome.
Sensory Resolution24, 48, 72, 96 (if needed) hours postoperativelyPatients are contacted and asked questions regarding their motor strength and sensation in their shoulder.
Motor Block Resolution24, 48, 72, 96 (if needed) hours postoperativelyPatients are contacted and asked questions regarding their motor strength and sensation in their shoulder.
Time to Readiness for DischargePostanesthesia care unit (0-6 hours postoperative)Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System.
Postanesthesia Care Unit Length of StayPostanesthesia care unit (0-6 hours postoperative)Total length of PACU stay as defined by time of PACU admission to PACU discharge.
Duration of Analgesic Block24, 48, 72, 96 (if needed) hours postoperativelyPatients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked When did your pain relief from the block completely wear off? This indicates the block duration.

Countries

United States

Participant flow

Participants by arm

ArmCount
Liposomal Bupivacaine & Standard Bupivacaine
Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
55
Standard Bupivacaine & Dexamethasone
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
56
Total111

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPhysician Decision10

Baseline characteristics

CharacteristicTotalStandard Bupivacaine & DexamethasoneLiposomal Bupivacaine & Standard Bupivacaine
Age, Continuous53 year49 year55 year
American Society of Anesthesiology Status
ASA Status I
22 Participants12 Participants10 Participants
American Society of Anesthesiology Status
ASA status II
89 Participants44 Participants45 Participants
Body Mass Index, kg/m^227.6 Kg/m^2
STANDARD_DEVIATION 4.1
27.5 Kg/m^2
STANDARD_DEVIATION 4.1
27.6 Kg/m^2
STANDARD_DEVIATION 4.1
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants4 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
104 Participants52 Participants52 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants0 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
5 Participants3 Participants2 Participants
Race (NIH/OMB)
Black or African American
10 Participants5 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants2 Participants3 Participants
Race (NIH/OMB)
White
91 Participants46 Participants45 Participants
Region of Enrollment
United States
111 Participants56 Participants55 Participants
Sex: Female, Male
Female
20 Participants8 Participants12 Participants
Sex: Female, Male
Male
91 Participants48 Participants43 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 550 / 56
other
Total, other adverse events
6 / 553 / 56
serious
Total, serious adverse events
0 / 550 / 56

Outcome results

Primary

Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours

NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome.

Time frame: First 72 hours pain

ArmMeasureValue (MEAN)Dispersion
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain at Rest Over 72 Hours2.4 score on a scaleStandard Deviation 1.9
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain at Rest Over 72 Hours3.4 score on a scaleStandard Deviation 1.9
Secondary

Brief Pain Inventory Short-form

The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life.

Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

ArmMeasureGroupValue (MEAN)Dispersion
Liposomal Bupivacaine & Standard BupivacaineBrief Pain Inventory Short-formPostanesthesia care unit (0-6 hours postoperative)1.2 score on a scaleStandard Deviation 2
Liposomal Bupivacaine & Standard BupivacaineBrief Pain Inventory Short-formPostoperative day 11.4 score on a scaleStandard Deviation 2
Liposomal Bupivacaine & Standard BupivacaineBrief Pain Inventory Short-formPostoperative day 22.4 score on a scaleStandard Deviation 2.3
Liposomal Bupivacaine & Standard BupivacaineBrief Pain Inventory Short-formPostoperative day 32.2 score on a scaleStandard Deviation 2
Liposomal Bupivacaine & Standard BupivacaineBrief Pain Inventory Short-formPostoperative day 42.5 score on a scaleStandard Deviation 2.3
Liposomal Bupivacaine & Standard BupivacaineBrief Pain Inventory Short-formPostoperative day 72.2 score on a scaleStandard Deviation 2.1
Standard Bupivacaine & DexamethasoneBrief Pain Inventory Short-formPostoperative day 43.6 score on a scaleStandard Deviation 2.1
Standard Bupivacaine & DexamethasoneBrief Pain Inventory Short-formPostanesthesia care unit (0-6 hours postoperative)0.6 score on a scaleStandard Deviation 1.4
Standard Bupivacaine & DexamethasoneBrief Pain Inventory Short-formPostoperative day 33.4 score on a scaleStandard Deviation 2.1
Standard Bupivacaine & DexamethasoneBrief Pain Inventory Short-formPostoperative day 11.8 score on a scaleStandard Deviation 2.3
Standard Bupivacaine & DexamethasoneBrief Pain Inventory Short-formPostoperative day 72.9 score on a scaleStandard Deviation 2.1
Standard Bupivacaine & DexamethasoneBrief Pain Inventory Short-formPostoperative day 23.6 score on a scaleStandard Deviation 2.5
Secondary

Duration of Analgesic Block

Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked When did your pain relief from the block completely wear off? This indicates the block duration.

Time frame: 24, 48, 72, 96 (if needed) hours postoperatively

ArmMeasureValue (MEDIAN)
Liposomal Bupivacaine & Standard BupivacaineDuration of Analgesic Block26 Hours
Standard Bupivacaine & DexamethasoneDuration of Analgesic Block27 Hours
Secondary

Motor Block Resolution

Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.

Time frame: 24, 48, 72, 96 (if needed) hours postoperatively

ArmMeasureValue (MEDIAN)
Liposomal Bupivacaine & Standard BupivacaineMotor Block Resolution27 Hours
Standard Bupivacaine & DexamethasoneMotor Block Resolution27 Hours
Secondary

Numerical Rating Scale (NRS) Pain at Rest

NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome.

Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

ArmMeasureGroupValue (MEAN)Dispersion
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain at RestPostanesthesia care unit (0-6 hours postoperative)1.3 score on a scaleStandard Deviation 1.9
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain at RestPostoperative day 12.1 score on a scaleStandard Deviation 2.6
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain at RestPostoperative day 22.5 score on a scaleStandard Deviation 2.3
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain at RestPostoperative day 32.4 score on a scaleStandard Deviation 2.2
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain at RestPostoperative day 42.5 score on a scaleStandard Deviation 2
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain at RestPostoperative day 71.7 score on a scaleStandard Deviation 2
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain at RestPostoperative day 43.0 score on a scaleStandard Deviation 2.2
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain at RestPostanesthesia care unit (0-6 hours postoperative)0.9 score on a scaleStandard Deviation 1.8
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain at RestPostoperative day 33.3 score on a scaleStandard Deviation 2.4
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain at RestPostoperative day 13.0 score on a scaleStandard Deviation 2.5
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain at RestPostoperative day 72.3 score on a scaleStandard Deviation 2.2
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain at RestPostoperative day 24.1 score on a scaleStandard Deviation 2.7
Secondary

Numerical Rating Scale (NRS) Pain With Movement

NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome.

Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

ArmMeasureGroupValue (MEAN)Dispersion
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain With MovementPostanesthesia care unit (0-6 hours postoperative)8.9 score on a scaleStandard Deviation 4.3
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain With MovementPostoperative day 14.0 score on a scaleStandard Deviation 3.1
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain With MovementPostoperative day 24.1 score on a scaleStandard Deviation 2.9
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain With MovementPostoperative day 34.0 score on a scaleStandard Deviation 2.7
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain With MovementPostoperative day 44.0 score on a scaleStandard Deviation 2.8
Liposomal Bupivacaine & Standard BupivacaineNumerical Rating Scale (NRS) Pain With MovementPostoperative day 73.9 score on a scaleStandard Deviation 2.6
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain With MovementPostoperative day 44.9 score on a scaleStandard Deviation 2.4
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain With MovementPostanesthesia care unit (0-6 hours postoperative)9.98 score on a scaleStandard Deviation 3.2
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain With MovementPostoperative day 35.3 score on a scaleStandard Deviation 2.3
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain With MovementPostoperative day 14.3 score on a scaleStandard Deviation 3.1
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain With MovementPostoperative day 74.7 score on a scaleStandard Deviation 2.5
Standard Bupivacaine & DexamethasoneNumerical Rating Scale (NRS) Pain With MovementPostoperative day 25.6 score on a scaleStandard Deviation 3.1
Secondary

Opioid Consumption

Opioid consumption, measured in oral morphine equivalents

Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

ArmMeasureGroupValue (MEAN)Dispersion
Liposomal Bupivacaine & Standard BupivacaineOpioid ConsumptionPostanesthesia care unit (0-6 hours postoperative)1.8 Oral Morphine Equivalents (mg)Standard Deviation 4.5
Liposomal Bupivacaine & Standard BupivacaineOpioid ConsumptionPostoperative day 14.8 Oral Morphine Equivalents (mg)Standard Deviation 8.6
Liposomal Bupivacaine & Standard BupivacaineOpioid ConsumptionPostoperative day 212.3 Oral Morphine Equivalents (mg)Standard Deviation 15.6
Liposomal Bupivacaine & Standard BupivacaineOpioid ConsumptionPostoperative day 38.9 Oral Morphine Equivalents (mg)Standard Deviation 12.5
Liposomal Bupivacaine & Standard BupivacaineOpioid ConsumptionPostoperative day 46.9 Oral Morphine Equivalents (mg)Standard Deviation 13.8
Liposomal Bupivacaine & Standard BupivacaineOpioid ConsumptionPostoperative day 73.7 Oral Morphine Equivalents (mg)Standard Deviation 7.4
Standard Bupivacaine & DexamethasoneOpioid ConsumptionPostoperative day 49.7 Oral Morphine Equivalents (mg)Standard Deviation 15.5
Standard Bupivacaine & DexamethasoneOpioid ConsumptionPostanesthesia care unit (0-6 hours postoperative)1.7 Oral Morphine Equivalents (mg)Standard Deviation 4.6
Standard Bupivacaine & DexamethasoneOpioid ConsumptionPostoperative day 313.2 Oral Morphine Equivalents (mg)Standard Deviation 14
Standard Bupivacaine & DexamethasoneOpioid ConsumptionPostoperative day 18.1 Oral Morphine Equivalents (mg)Standard Deviation 10.4
Standard Bupivacaine & DexamethasoneOpioid ConsumptionPostoperative day 73.3 Oral Morphine Equivalents (mg)Standard Deviation 7.2
Standard Bupivacaine & DexamethasoneOpioid ConsumptionPostoperative day 218.2 Oral Morphine Equivalents (mg)Standard Deviation 20.8
Secondary

Patient Satisfaction With Pain Management: Scale

Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction

Time frame: Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7

ArmMeasureGroupValue (MEAN)Dispersion
Liposomal Bupivacaine & Standard BupivacainePatient Satisfaction With Pain Management: ScalePostoperative day 19.3 score on a scaleStandard Deviation 1.4
Liposomal Bupivacaine & Standard BupivacainePatient Satisfaction With Pain Management: ScalePostoperative day 39.2 score on a scaleStandard Deviation 1.4
Liposomal Bupivacaine & Standard BupivacainePatient Satisfaction With Pain Management: ScalePostanesthesia care unit (0-6 hours postoperative)9.4 score on a scaleStandard Deviation 1.3
Liposomal Bupivacaine & Standard BupivacainePatient Satisfaction With Pain Management: ScalePostoperative day 28.9 score on a scaleStandard Deviation 2.1
Liposomal Bupivacaine & Standard BupivacainePatient Satisfaction With Pain Management: ScalePostoperative day 79.1 score on a scaleStandard Deviation 1.5
Liposomal Bupivacaine & Standard BupivacainePatient Satisfaction With Pain Management: ScalePostoperative day 49.1 score on a scaleStandard Deviation 1.2
Standard Bupivacaine & DexamethasonePatient Satisfaction With Pain Management: ScalePostoperative day 78.4 score on a scaleStandard Deviation 2.1
Standard Bupivacaine & DexamethasonePatient Satisfaction With Pain Management: ScalePostanesthesia care unit (0-6 hours postoperative)9.8 score on a scaleStandard Deviation 0.5
Standard Bupivacaine & DexamethasonePatient Satisfaction With Pain Management: ScalePostoperative day 19.2 score on a scaleStandard Deviation 1.6
Standard Bupivacaine & DexamethasonePatient Satisfaction With Pain Management: ScalePostoperative day 28.6 score on a scaleStandard Deviation 1.8
Standard Bupivacaine & DexamethasonePatient Satisfaction With Pain Management: ScalePostoperative day 38.6 score on a scaleStandard Deviation 1.7
Standard Bupivacaine & DexamethasonePatient Satisfaction With Pain Management: ScalePostoperative day 48.5 score on a scaleStandard Deviation 1.7
Secondary

Postanesthesia Care Unit Length of Stay

Total length of PACU stay as defined by time of PACU admission to PACU discharge.

Time frame: Postanesthesia care unit (0-6 hours postoperative)

ArmMeasureValue (MEDIAN)
Liposomal Bupivacaine & Standard BupivacainePostanesthesia Care Unit Length of Stay163.5 minutes
Standard Bupivacaine & DexamethasonePostanesthesia Care Unit Length of Stay163 minutes
Secondary

Sensory Resolution

Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder.

Time frame: 24, 48, 72, 96 (if needed) hours postoperatively

ArmMeasureValue (MEDIAN)
Liposomal Bupivacaine & Standard BupivacaineSensory Resolution27 Hours
Standard Bupivacaine & DexamethasoneSensory Resolution31 Hours
Secondary

Time to Readiness for Discharge

Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System.

Time frame: Postanesthesia care unit (0-6 hours postoperative)

ArmMeasureValue (MEDIAN)
Liposomal Bupivacaine & Standard BupivacaineTime to Readiness for Discharge90 minutes
Standard Bupivacaine & DexamethasoneTime to Readiness for Discharge90 minutes

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026