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Comparison of Analgesic Efficacy Between of Interscalene Block With Liposomal Bupivacaine With Bupivacaine and Dexamethasone

Comparison of the Analgesic Efficacy of a Single Shot Interscalene Block With Liposomal Bupivacaine to Bupivacaine With Dexamethasone as an adjuvant-a Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03969875
Enrollment
90
Registered
2019-05-31
Start date
2018-08-18
Completion date
2022-04-05
Last updated
2024-05-07

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

Conditions

Total Shoulder Arthroplasty, Shoulder Osteoarthritis

Keywords

Liposomal bupivacaine, Dexamethasone, Interscalene catheter, Interscalene single shot

Brief summary

Pain management after shoulder surgeries poses a unique challenge to the surgeon as well as the anesthesiologist. Regional anesthesia in the form of interscalene approach to the brachial plexus as an adjunct to general anesthesia or as a sole primary technique comes to one's rescue. Interscalene block either as single shot or as a catheter is an established modality for effective analgesia which facilitates early mobilization helping in physical therapy and early discharge. With the help of local anesthetic injected as a single shot, analgesia usually lasts less than 24 hours. Recent research in regional anesthesia is advancing towards adjuvants which will prolong the duration of local anesthesia. This has introduced the concept of multimodal perineural analgesia (MMPNA) whereby multiple agents with differing mechanisms of action are used with the goal of providing perineural analgesia while avoiding exposure to high and potentially toxic levels of individual agents. Some of the commonly used adjuvants in clinical studies are fentanyl, buprenorphine, morphine, tramadol, magnesium, epinephrine, ketamine, non-steroidal anti-inflammatory drug (NSAID), midazolam, parecoxib, ketorolac, clonidine, dexmedetomidine, dexamethasone, neostigmine and potassium. They find a distinct place in wide spread clinical practice as an off-label use. Steroids have a long history of safe use in epidural space for treatment of radicular pain due to nerve irritation. Dexamethasone is used routinely as a part of anti- emetic prophylaxis and anti-inflammatory effect. Methyl prednisone was the first steroid to be used as an adjuvant. Dexamethasone was first used as an adjuvant in 2003. It has been hypothesized that steroids induce a degree of vasoconstriction, thereby reducing local anesthetic absorption, tend to have an opioid sparing effect. Another theory suggests that it increases the activity of inhibitory potassium channels on nociceptive C-fibers (via glucocorticoid receptors), thus decreasing their activity. Several studies have demonstrated promising results with the use of 8mg of perineural dexamethasone. No neuronal injury has been reported in in vivo studies. Though there are several studies which report usage of dexamethasone in varying doses of 2mg to 8mg, the optimal effective dose of dexamethasone as an adjuvant for nerve block remains unknown. Some studies have suggested perineural is more effective than IV as an adjuvant . Liposomal bupivacaine, a formulation where bupivacaine is encapsulated into multivesicular liposomes, making it a slow and controlled release from the liposomes, was originally indicated for wound infiltration at the surgical site to provide post-surgical analgesia. Studies have demonstrated efficacy up to 24 hours in femoral nerve block in total knee arthroplasty. Recent approval of liposomal bupivacaine in interscalene block for shoulder surgeries by FDA opens an arena unexplored in the world of regional anesthesia. Current opioid epidemic, a crisis in health care forces healthcare providers to consider alternate analgesic modalities without compromising patient comfort. Regional anesthesia has revolutionized peri-operative pain management by avoiding opioids and their side effects. Use of adjuvants to the current regional techniques holds promise in postsurgical analgesia. The researchers propose to compare the analgesic efficacy of liposomal bupivacaine to bupivacaine with dexamethasone as an adjuvant in interscalene block with catheters for shoulder surgeries. Till date, there is not a single study comparing the three in current literature.

Detailed description

There have been several studies demonstrating efficacy of dexamethasone in prolonging the analgesic effect when administered both perineurally and intra-venously as an adjuvant to local anesthesia demonstrating a dose effect relationship. Liposomal bupivacaine has shown promising results in total knee arthroplasty and there are a limited number of studies demonstrating efficacy in total shoulder arthroplasty. If by comparing dexamethasone as an adjuvant to bupivacaine and liposomal formulation is deciphered, it can help in avoiding costs associated with liposomal bupivacaine extending post-operative analgesia avoiding narcotics and reducing health care costs. And comparing the two to the standard catheters helps us understand if they have a role in pain management in the future.

Interventions

rescue catheters attached to a PCA pump

DRUGLiposomal bupivacaine

10 cc

DRUGDexamethasone

1 cc of 4mg

DRUGBupivacaine

0.5% bupivacaine

Sponsors

Icahn School of Medicine at Mount Sinai
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* All patients between age 18-80 years undergoing elective primary total shoulder arthroplasty procedure. * All patients who speak read and understand English will be included for follow up purposes.

Exclusion criteria

* Patient refusal * ASA 5 * presence of coagulopathy * severe lung disease * contralateral diaphragmatic palsy * insulin-dependent diabetes * hepatic disease/failure * kidney disease/failure * pregnancy * chronic opioid use (defined as opioid use for \>3 months), or allergy to any of the study medications.

Design outcomes

Primary

MeasureTime frameDescription
Numerical Rating Score for Painat 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hoursNumerical rating score for pain is assessed from 0 to 10, with 0 being no pain and 10 being worst pain.

Secondary

MeasureTime frameDescription
Total Narcotic Consumptionhospital stay, up to 48 hoursTotal narcotic consumption in mg morphine equivalents (MME) during hospital stay
Arm Weaknessat 6 hours, 12 hours, 18 hours, 24 hours, 36 hoursArm weakness as assessed by flexion and extension at wrist -- total scale from 1 to 10, with 10 being most weakness
Arm Numbnessat 6 hours, 12 hours, 18 hours, 24 hours, 36 hoursArm numbness assessed by the sensation at deltoid area. Sensation total scale from 1 to 10, with higher number indicating most sensation.
Time of Analgesia DurationDay 1The duration for which the patient has no pain on Day 1
Time of Motor RecoveryDay 1Time of motor recovery on Day 1
Sensory Intactat 6 hours, 12 hours, 18 hours, 24 hours, 36 hoursSensory testing by using pinprick in the region of C5 dermatome. Scale from 1 to 10, with higher score indicating more sensation.
Time to First Analgesic RequestDay 1Time to first analgesic request on Day 1
PACU Length of StayDay 1Post-anesthesia Care Unit length of stay in hours on Day 1
Hospital Length of Stayup to 3 daysLength of stay for duration of hospital admission
Number of Complication Eventsup to 3 daysNumber of complications - any associated complications like nausea, vomiting, dizziness, horner's syndrome, hoarseness and dyspnea
Number of Participants With Quality of Sleep Ratingaverage of 3 daysPatient to rate their quality of sleep as good, average, or bad
Number of Participants With Patient's Satisfactionduring the hospital stay, up to 3 daysNumber of Participants with Patient satisfaction. Patients were asked if they were satisfied.
Change in Patient Reported Outcomes Measurement Information System (PROMIS)baseline and one week post-opPROMIS global assessment assesses physical and mental activities of daily living scored from 0 (poor) to 5 (excellent) at first post-operative visit as compared to baseline. Each scale from 0-100, higher score indicates better health outcomes.
Hand Strengthat 6 hours, 12 hours, 18 hours, 24 hours, 36 hoursHand strength assessed by using dynamometer, a device for measuring the amount of static force that can squeeze around a dynamometer, in kilograms.

Countries

United States

Participant flow

Recruitment details

Recruitment from 2018 to 2022

Pre-assignment details

There were 155 eligible participants and 90 were randomized.

Participants by arm

ArmCount
Interscalene Catheter
Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour. Interscalene catheter: rescue catheters attached to a PCA pump Bupivacaine: 0.5% bupivacaine
24
Interscalene With Bupivacaine and Dexamethasone
Interscalene single shot with bupivacaine and dexamethasone as adjuvant 0.5% bupivacaine 14cc with 1 cc of 4mg dexamethasone, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion. Dexamethasone: 1 cc of 4mg Bupivacaine: 0.5% bupivacaine
24
Interscalene Single Shot With Liposomal Bupivacaine
Liposomal bupivacaine 10cc of exparel with 0.5% bupivacaine 5cc, total 15cc with rescue catheter attached to a PCA pump with normal saline at 6cc/hour infusion. Liposomal bupivacaine: 10 cc
24
Total72

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall Studydid not receive allocated intervention334
Overall StudyProtocol Violation422

Baseline characteristics

CharacteristicInterscalene CatheterInterscalene With Bupivacaine and DexamethasoneInterscalene Single Shot With Liposomal BupivacaineTotal
Age, Continuous69.08 years
STANDARD_DEVIATION 6.23
71.75 years
STANDARD_DEVIATION 6.58
68 years
STANDARD_DEVIATION 8.5
69.61 years
STANDARD_DEVIATION 7.25
Current Smoker0 Participants2 Participants2 Participants4 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants5 Participants3 Participants10 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
22 Participants19 Participants21 Participants62 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Level of Education
Bachelor
7 Participants8 Participants10 Participants25 Participants
Level of Education
Graduate
6 Participants6 Participants8 Participants20 Participants
Level of Education
High School
10 Participants9 Participants5 Participants24 Participants
Level of Education
Under High School
1 Participants1 Participants1 Participants3 Participants
Number of Participant Employed13 Participants3 Participants8 Participants24 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants1 Participants1 Participants2 Participants
Race (NIH/OMB)
Black or African American
4 Participants5 Participants3 Participants12 Participants
Race (NIH/OMB)
More than one race
2 Participants5 Participants3 Participants10 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
18 Participants13 Participants17 Participants48 Participants
Sex: Female, Male
Female
14 Participants17 Participants13 Participants44 Participants
Sex: Female, Male
Male
10 Participants7 Participants11 Participants28 Participants
Side of Surgery
Left
12 Participants11 Participants9 Participants32 Participants
Side of Surgery
Right
12 Participants13 Participants15 Participants40 Participants
The American Society of Anesthesiologists (ASA) Physical Status Classification System
ASA I
1 Participants0 Participants0 Participants1 Participants
The American Society of Anesthesiologists (ASA) Physical Status Classification System
ASA II
8 Participants18 Participants12 Participants38 Participants
The American Society of Anesthesiologists (ASA) Physical Status Classification System
ASA III
15 Participants6 Participants12 Participants33 Participants
Type of Shoulder Replacement
Anatomic
10 Participants13 Participants12 Participants35 Participants
Type of Shoulder Replacement
Reverse
14 Participants11 Participants12 Participants37 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 240 / 240 / 24
other
Total, other adverse events
0 / 240 / 240 / 24
serious
Total, serious adverse events
0 / 240 / 240 / 24

Outcome results

Primary

Numerical Rating Score for Pain

Numerical rating score for pain is assessed from 0 to 10, with 0 being no pain and 10 being worst pain.

Time frame: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours

ArmMeasureGroupValue (MEDIAN)
Interscalene CatheterNumerical Rating Score for Pain6 hours0.00 score on a scale
Interscalene CatheterNumerical Rating Score for Pain12 hours0.00 score on a scale
Interscalene CatheterNumerical Rating Score for Pain18 hours2.00 score on a scale
Interscalene CatheterNumerical Rating Score for Pain24 hours2.50 score on a scale
Interscalene CatheterNumerical Rating Score for Pain36 hours3.00 score on a scale
Interscalene CatheterNumerical Rating Score for Pain48 hours2.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneNumerical Rating Score for Pain48 hours2.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneNumerical Rating Score for Pain6 hours0.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneNumerical Rating Score for Pain24 hours3.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneNumerical Rating Score for Pain36 hours2.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneNumerical Rating Score for Pain12 hours0.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneNumerical Rating Score for Pain18 hours5.50 score on a scale
Interscalene Single Shot With Liposomal BupivacaineNumerical Rating Score for Pain12 hours2.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineNumerical Rating Score for Pain18 hours0.50 score on a scale
Interscalene Single Shot With Liposomal BupivacaineNumerical Rating Score for Pain48 hours2.50 score on a scale
Interscalene Single Shot With Liposomal BupivacaineNumerical Rating Score for Pain24 hours2.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineNumerical Rating Score for Pain6 hours0.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineNumerical Rating Score for Pain36 hours2.00 score on a scale
Secondary

Arm Numbness

Arm numbness assessed by the sensation at deltoid area. Sensation total scale from 1 to 10, with higher number indicating most sensation.

Time frame: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours

ArmMeasureGroupValue (MEDIAN)
Interscalene CatheterArm Numbness24 hours2.00 score on a scale
Interscalene CatheterArm Numbness18 hours2.00 score on a scale
Interscalene CatheterArm Numbness6 hours1.00 score on a scale
Interscalene CatheterArm Numbness12 hours2.00 score on a scale
Interscalene CatheterArm Numbness36 hours2.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneArm Numbness18 hours2.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneArm Numbness6 hours1.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneArm Numbness12 hours2.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneArm Numbness24 hours2.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneArm Numbness36 hours3.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineArm Numbness36 hours2.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineArm Numbness24 hours2.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineArm Numbness6 hours1.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineArm Numbness18 hours2.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineArm Numbness12 hours2.00 score on a scale
Secondary

Arm Weakness

Arm weakness as assessed by flexion and extension at wrist -- total scale from 1 to 10, with 10 being most weakness

Time frame: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours

ArmMeasureGroupValue (MEDIAN)
Interscalene CatheterArm Weakness24 hours4.00 score on a scale
Interscalene CatheterArm Weakness18 hours3.00 score on a scale
Interscalene CatheterArm Weakness6 hours2.00 score on a scale
Interscalene CatheterArm Weakness12 hours2.00 score on a scale
Interscalene CatheterArm Weakness36 hours5.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneArm Weakness18 hours4.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneArm Weakness6 hours2.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneArm Weakness12 hours3.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneArm Weakness24 hours5.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneArm Weakness36 hours5.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineArm Weakness36 hours5.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineArm Weakness24 hours5.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineArm Weakness6 hours2.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineArm Weakness18 hours4.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineArm Weakness12 hours4.00 score on a scale
Secondary

Change in Patient Reported Outcomes Measurement Information System (PROMIS)

PROMIS global assessment assesses physical and mental activities of daily living scored from 0 (poor) to 5 (excellent) at first post-operative visit as compared to baseline. Each scale from 0-100, higher score indicates better health outcomes.

Time frame: baseline and one week post-op

ArmMeasureGroupValue (MEAN)Dispersion
Interscalene CatheterChange in Patient Reported Outcomes Measurement Information System (PROMIS)Pre-Physical, baseline41.98 score on a scaleStandard Deviation 9.88
Interscalene CatheterChange in Patient Reported Outcomes Measurement Information System (PROMIS)Post-Physical, one week post-op44.44 score on a scaleStandard Deviation 9.57
Interscalene CatheterChange in Patient Reported Outcomes Measurement Information System (PROMIS)Pre-Mental, baseline50.00 score on a scaleStandard Deviation 12.18
Interscalene CatheterChange in Patient Reported Outcomes Measurement Information System (PROMIS)Post-Mental, one week post-op49.75 score on a scaleStandard Deviation 11.51
Interscalene With Bupivacaine and DexamethasoneChange in Patient Reported Outcomes Measurement Information System (PROMIS)Post-Mental, one week post-op52.14 score on a scaleStandard Deviation 10.41
Interscalene With Bupivacaine and DexamethasoneChange in Patient Reported Outcomes Measurement Information System (PROMIS)Pre-Physical, baseline42.42 score on a scaleStandard Deviation 8.83
Interscalene With Bupivacaine and DexamethasoneChange in Patient Reported Outcomes Measurement Information System (PROMIS)Pre-Mental, baseline51.64 score on a scaleStandard Deviation 11.01
Interscalene With Bupivacaine and DexamethasoneChange in Patient Reported Outcomes Measurement Information System (PROMIS)Post-Physical, one week post-op43.55 score on a scaleStandard Deviation 9.52
Interscalene Single Shot With Liposomal BupivacaineChange in Patient Reported Outcomes Measurement Information System (PROMIS)Post-Mental, one week post-op52.99 score on a scaleStandard Deviation 6.93
Interscalene Single Shot With Liposomal BupivacaineChange in Patient Reported Outcomes Measurement Information System (PROMIS)Post-Physical, one week post-op45.15 score on a scaleStandard Deviation 8.89
Interscalene Single Shot With Liposomal BupivacaineChange in Patient Reported Outcomes Measurement Information System (PROMIS)Pre-Mental, baseline51.44 score on a scaleStandard Deviation 8.35
Interscalene Single Shot With Liposomal BupivacaineChange in Patient Reported Outcomes Measurement Information System (PROMIS)Pre-Physical, baseline42.19 score on a scaleStandard Deviation 9.26
Secondary

Hand Strength

Hand strength assessed by using dynamometer, a device for measuring the amount of static force that can squeeze around a dynamometer, in kilograms.

Time frame: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours

ArmMeasureGroupValue (MEDIAN)
Interscalene CatheterHand Strength12 hours - Right hand14.75 kg
Interscalene CatheterHand Strength18 hours Left hand13.95 kg
Interscalene CatheterHand Strength18 hours - Right hand16.80 kg
Interscalene CatheterHand Strength24 hours - Right hand16.90 kg
Interscalene CatheterHand Strength6 hours - Left hand16.90 kg
Interscalene CatheterHand Strength36 hours - Right hand13.50 kg
Interscalene CatheterHand Strength24 hours - Left hand15.10 kg
Interscalene CatheterHand Strength12 hours - Left hand13.50 kg
Interscalene CatheterHand Strength36 hours - Left hand16.50 kg
Interscalene CatheterHand Strength6 hours - Right hand14.90 kg
Interscalene With Bupivacaine and DexamethasoneHand Strength12 hours - Right hand14.50 kg
Interscalene With Bupivacaine and DexamethasoneHand Strength24 hours - Left hand19.00 kg
Interscalene With Bupivacaine and DexamethasoneHand Strength6 hours - Right hand13.50 kg
Interscalene With Bupivacaine and DexamethasoneHand Strength18 hours - Right hand16.35 kg
Interscalene With Bupivacaine and DexamethasoneHand Strength18 hours Left hand16.50 kg
Interscalene With Bupivacaine and DexamethasoneHand Strength6 hours - Left hand18.00 kg
Interscalene With Bupivacaine and DexamethasoneHand Strength24 hours - Right hand19.30 kg
Interscalene With Bupivacaine and DexamethasoneHand Strength36 hours - Left hand20.00 kg
Interscalene With Bupivacaine and DexamethasoneHand Strength12 hours - Left hand19.00 kg
Interscalene With Bupivacaine and DexamethasoneHand Strength36 hours - Right hand20.50 kg
Interscalene Single Shot With Liposomal BupivacaineHand Strength36 hours - Left hand20.00 kg
Interscalene Single Shot With Liposomal BupivacaineHand Strength6 hours - Left hand16.35 kg
Interscalene Single Shot With Liposomal BupivacaineHand Strength12 hours - Left hand16.85 kg
Interscalene Single Shot With Liposomal BupivacaineHand Strength18 hours Left hand19.50 kg
Interscalene Single Shot With Liposomal BupivacaineHand Strength24 hours - Left hand20.00 kg
Interscalene Single Shot With Liposomal BupivacaineHand Strength36 hours - Right hand18.50 kg
Interscalene Single Shot With Liposomal BupivacaineHand Strength6 hours - Right hand10.00 kg
Interscalene Single Shot With Liposomal BupivacaineHand Strength12 hours - Right hand12.00 kg
Interscalene Single Shot With Liposomal BupivacaineHand Strength18 hours - Right hand12.40 kg
Interscalene Single Shot With Liposomal BupivacaineHand Strength24 hours - Right hand17.50 kg
Secondary

Hospital Length of Stay

Length of stay for duration of hospital admission

Time frame: up to 3 days

ArmMeasureValue (MEDIAN)
Interscalene CatheterHospital Length of Stay2.75 days
Interscalene With Bupivacaine and DexamethasoneHospital Length of Stay2 days
Interscalene Single Shot With Liposomal BupivacaineHospital Length of Stay1.75 days
Secondary

Number of Complication Events

Number of complications - any associated complications like nausea, vomiting, dizziness, horner's syndrome, hoarseness and dyspnea

Time frame: up to 3 days

ArmMeasureGroupValue (NUMBER)
Interscalene CatheterNumber of Complication EventsNausea3 events
Interscalene CatheterNumber of Complication EventsVomiting0 events
Interscalene CatheterNumber of Complication EventsDizziness2 events
Interscalene CatheterNumber of Complication EventsHorners2 events
Interscalene CatheterNumber of Complication EventsHoarseness1 events
Interscalene CatheterNumber of Complication EventsDyspnea0 events
Interscalene With Bupivacaine and DexamethasoneNumber of Complication EventsDyspnea0 events
Interscalene With Bupivacaine and DexamethasoneNumber of Complication EventsNausea2 events
Interscalene With Bupivacaine and DexamethasoneNumber of Complication EventsHorners0 events
Interscalene With Bupivacaine and DexamethasoneNumber of Complication EventsHoarseness3 events
Interscalene With Bupivacaine and DexamethasoneNumber of Complication EventsVomiting0 events
Interscalene With Bupivacaine and DexamethasoneNumber of Complication EventsDizziness2 events
Interscalene Single Shot With Liposomal BupivacaineNumber of Complication EventsVomiting0 events
Interscalene Single Shot With Liposomal BupivacaineNumber of Complication EventsDizziness2 events
Interscalene Single Shot With Liposomal BupivacaineNumber of Complication EventsDyspnea0 events
Interscalene Single Shot With Liposomal BupivacaineNumber of Complication EventsHorners0 events
Interscalene Single Shot With Liposomal BupivacaineNumber of Complication EventsNausea1 events
Interscalene Single Shot With Liposomal BupivacaineNumber of Complication EventsHoarseness0 events
Secondary

Number of Participants With Patient's Satisfaction

Number of Participants with Patient satisfaction. Patients were asked if they were satisfied.

Time frame: during the hospital stay, up to 3 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Interscalene CatheterNumber of Participants With Patient's Satisfaction16 Participants
Interscalene With Bupivacaine and DexamethasoneNumber of Participants With Patient's Satisfaction16 Participants
Interscalene Single Shot With Liposomal BupivacaineNumber of Participants With Patient's Satisfaction16 Participants
Secondary

Number of Participants With Quality of Sleep Rating

Patient to rate their quality of sleep as good, average, or bad

Time frame: average of 3 days

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Interscalene CatheterNumber of Participants With Quality of Sleep RatingAverage5 Participants
Interscalene CatheterNumber of Participants With Quality of Sleep RatingGood12 Participants
Interscalene CatheterNumber of Participants With Quality of Sleep RatingBad7 Participants
Interscalene With Bupivacaine and DexamethasoneNumber of Participants With Quality of Sleep RatingAverage6 Participants
Interscalene With Bupivacaine and DexamethasoneNumber of Participants With Quality of Sleep RatingGood9 Participants
Interscalene With Bupivacaine and DexamethasoneNumber of Participants With Quality of Sleep RatingBad9 Participants
Interscalene Single Shot With Liposomal BupivacaineNumber of Participants With Quality of Sleep RatingGood7 Participants
Interscalene Single Shot With Liposomal BupivacaineNumber of Participants With Quality of Sleep RatingBad10 Participants
Interscalene Single Shot With Liposomal BupivacaineNumber of Participants With Quality of Sleep RatingAverage7 Participants
Secondary

PACU Length of Stay

Post-anesthesia Care Unit length of stay in hours on Day 1

Time frame: Day 1

ArmMeasureValue (MEDIAN)
Interscalene CatheterPACU Length of Stay2.7 hours
Interscalene With Bupivacaine and DexamethasonePACU Length of Stay2.44 hours
Interscalene Single Shot With Liposomal BupivacainePACU Length of Stay3 hours
Secondary

Sensory Intact

Sensory testing by using pinprick in the region of C5 dermatome. Scale from 1 to 10, with higher score indicating more sensation.

Time frame: at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours

ArmMeasureGroupValue (MEDIAN)
Interscalene CatheterSensory Intact24 hours2.00 score on a scale
Interscalene CatheterSensory Intact18 hours2.00 score on a scale
Interscalene CatheterSensory Intact36 hours2.00 score on a scale
Interscalene CatheterSensory Intact12 hours2.00 score on a scale
Interscalene CatheterSensory Intact6 hours1.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneSensory Intact6 hours1.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneSensory Intact12 hours2.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneSensory Intact18 hours2.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneSensory Intact24 hours2.00 score on a scale
Interscalene With Bupivacaine and DexamethasoneSensory Intact36 hours2.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineSensory Intact36 hours2.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineSensory Intact24 hours2.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineSensory Intact6 hours1.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineSensory Intact18 hours2.00 score on a scale
Interscalene Single Shot With Liposomal BupivacaineSensory Intact12 hours2.00 score on a scale
Secondary

Time of Analgesia Duration

The duration for which the patient has no pain on Day 1

Time frame: Day 1

ArmMeasureValue (MEDIAN)
Interscalene CatheterTime of Analgesia Duration6.00 hours
Interscalene With Bupivacaine and DexamethasoneTime of Analgesia Duration11.00 hours
Interscalene Single Shot With Liposomal BupivacaineTime of Analgesia Duration8.00 hours
Secondary

Time of Motor Recovery

Time of motor recovery on Day 1

Time frame: Day 1

ArmMeasureValue (MEDIAN)
Interscalene CatheterTime of Motor Recovery12.00 hours
Interscalene With Bupivacaine and DexamethasoneTime of Motor Recovery14.00 hours
Interscalene Single Shot With Liposomal BupivacaineTime of Motor Recovery12.00 hours
Secondary

Time to First Analgesic Request

Time to first analgesic request on Day 1

Time frame: Day 1

ArmMeasureValue (MEDIAN)
Interscalene CatheterTime to First Analgesic Request1.50 hours
Interscalene With Bupivacaine and DexamethasoneTime to First Analgesic Request3.50 hours
Interscalene Single Shot With Liposomal BupivacaineTime to First Analgesic Request2.19 hours
Secondary

Total Narcotic Consumption

Total narcotic consumption in mg morphine equivalents (MME) during hospital stay

Time frame: hospital stay, up to 48 hours

ArmMeasureValue (MEDIAN)
Interscalene CatheterTotal Narcotic Consumption30.00 MME
Interscalene With Bupivacaine and DexamethasoneTotal Narcotic Consumption21.05 MME
Interscalene Single Shot With Liposomal BupivacaineTotal Narcotic Consumption13.25 MME

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