Comparison of Analgesic Efficacy Between of Interscalene... | NCT03969875

NCT03969875

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

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.

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Interscalene catheter	Active Comparator	Interscalene catheter 0.5 % bupivacaine 15cc with rescue catheters attached to a PCA pump with bupivacaine infusion at 6cc /hour.	Device: Interscalene catheter Drug: Bupivacaine
Interscalene single shot with liposomal bupivacaine	Experimental	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.	Drug: Liposomal bupivacaine
Interscalene with bupivacaine and dexamethasone	Experimental	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.	Drug: Dexamethasone Drug: Bupivacaine

Name	Type	Description	Arm Group Labels	Other Names
Interscalene catheter	Device	rescue catheters attached to a PCA pump	Interscalene catheter

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours

Secondary Outcomes

Measure	Description	Time Frame
Time to First Analgesic Request	Time to first analgesic request on Day 1	Day 1
Total Narcotic Consumption	Total narcotic consumption in mg morphine equivalents (MME) during hospital stay

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Icahn School of Medicine at Mount Sinai		New York	New York	10029	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28157791	Background	Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.
23587874

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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
FG001	Interscalene With Bupivacaine and Dexamethasone

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Jun 25, 2021

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	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
BG001	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
BG002	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
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00024 BG00124 BG00224 BG00372

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00069.08± 6.23 BG00171.75± 6.58 BG00268± 8.50 BG003

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00014 BG00117 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0002 BG0015 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Type of Shoulder Replacement

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Anatomic	BG00010 BG00113 BG002

Side of Surgery

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Right	BG00012 BG00113 BG002

The American Society of Anesthesiologists (ASA) Physical Status Classification System

ASA I - A normal healthy patient

ASA II - A patient with mild systemic disease without significant functional limitation

ASA III - A patient with severe systemic disease with significant functional limitation

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
ASA I	BG0001 BG001

Current Smoker

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG0000 BG0012 BG002

Level of Education

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Under High School	BG0001 BG0011 BG002

Number of Participant Employed

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
	BG00013 BG0013 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Posted

Median

Inter-Quartile Range

score on a scale

at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours, 48 hours

ID	Title	Description
OG000	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
OG001	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
OG002	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

Units	Counts
Participants	OG00024 OG00124 OG00224

Title

Denominators

Categories

6 hours

Title	Measurements
	OG0000.00(0.00 to 2.25) OG0010.00(0.00 to 3.00) OG0020.00(0.00 to 1.00)

12 hours

Secondary

Time to First Analgesic Request

Time to first analgesic request on Day 1

Posted

Median

Inter-Quartile Range

hours

Day 1

ID	Title	Description
OG000	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
OG001	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
OG002	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

Units

Secondary

Total Narcotic Consumption

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

Posted

Median

Inter-Quartile Range

MME

hospital stay, up to 48 hours

ID	Title	Description
OG000	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
OG001	Interscalene With Bupivacaine and Dexamethasone Bupivacaine	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
OG002	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

Secondary

Arm Weakness

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

Posted

Median

Full Range

score on a scale

at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

Posted

Median

Inter-Quartile Range

score on a scale

at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours

ID	Title	Description
OG000	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
OG001	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
OG002	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

Secondary

Time of Analgesia Duration

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

Posted

Median

Inter-Quartile Range

hours

Day 1

ID	Title	Description
OG000	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
OG001	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
OG002	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

Units

Secondary

Time of Motor Recovery

Time of motor recovery on Day 1

Posted

Median

Inter-Quartile Range

hours

Day 1

ID	Title	Description
OG000	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
OG001	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
OG002	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

Units	Counts

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.

Posted

Median

Inter-Quartile Range

score on a scale

at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

Posted

Median

Inter-Quartile Range

at 6 hours, 12 hours, 18 hours, 24 hours, 36 hours

ID	Title	Description
OG000	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
OG001	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
OG002	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

Secondary

PACU Length of Stay

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

Posted

Median

Inter-Quartile Range

hours

Day 1

ID	Title	Description
OG000	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
OG001	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
OG002	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

Units

Secondary

Hospital Length of Stay

Length of stay for duration of hospital admission

Posted

Median

Inter-Quartile Range

days

up to 3 days

ID	Title	Description
OG000	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
OG001	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
OG002	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

Units

Secondary

Number of Complication Events

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

Posted

Number

events

up to 3 days

ID	Title	Description
OG000	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
OG001	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
OG002	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

Secondary

Number of Participants With Quality of Sleep Rating

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

Posted

Count of Participants

Participants

average of 3 days

ID	Title	Description
OG000	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
OG001	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
OG002	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

Secondary

Number of Participants With Patient's Satisfaction

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

Posted

Count of Participants

Participants

during the hospital stay, up to 3 days

ID	Title	Description
OG000	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
OG001	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
OG002	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

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.

Posted

Mean

Standard Deviation

score on a scale

baseline and one week post-op

ID	Title	Description
OG000	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
OG001	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
OG002	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

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (At Risk)
EG000	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	24	24
EG001	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	24	24
EG002	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	24	24

First MCP Posted Date

ID	Term
D003907	Dexamethasone
D002045	Bupivacaine

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds
D011083	Polycyclic Compounds
D013259	Steroids, Fluorinated
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814	Aniline Compounds
D000588	Amines

Units	Counts
Participants	OG00024 OG00124 OG00224

Units	Counts
Participants	OG00024 OG00124 OG00224

Units	Counts
Participants	OG00024 OG00124 OG00224

Units	Counts
Participants	OG00024 OG00124 OG00224

Units	Counts
Participants	OG00024 OG00124 OG00224