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Comparison of Interscalene Catheter to Single Injection Interscalene Blocks for Total Shoulder Arthroplasties

ConditionsPost Operative PainAnesthesiaNerve BlockShoulder Osteoarthritis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-90
SponsorMelinda Seering

About this trial

Comparison of post-operative pain after total shoulder surgery. The Principle Investigator will be comparing Exparel single shot block to Interscalene catheter

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Orthopedics service patients having reverse shoulder replacement surgery

ASA class I, II, or III.

Patients at least 18 years old but less than 90 years old.

Patients giving informed consent.

Disqualifiers

An inability to cooperate during the block placement.

Patients who do not meet criteria for a regional block: such as those on anti-coagulation,

Significant pulmonary disease or allergy to medications used for peripheral nerve blocks (Exparel, Bupivacaine and Ropivacaine)

Neuropathy of the planned extremity to block

Trial design

Design model

Parallel

Treatments tested in this trial

  • Interscalene Catheter

    Procedure/Surgery

    Pre-operatively the patient will have a interscalene catheter placed by a regional skilled anesthesiologist. The initial block will be with 20 cc of 0.5% Bupivacaine and maintained on an infusion post-operatively at 8cc/hr of 0.2% ropivacaine as is our intuitions protocol

  • Exparel Single Shot Interscalene Block

    Procedure/Surgery

    Pre-operatively the patient will have a interscalene single shot block with 133 mg Liposomal Bupivacaine and 10 ccs 0.5% Bupivacaine placed by a regional skilled anesthesiologist.

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: Interscalene CatheterActive comparator 1 intervention
Group B: Exparel Single Shot Interscalene BlockActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain Score Assessed by functional pain score at POD 1

The primary outcome to be assessed is to determine if there is a quantitative difference in post-operative pain scores as a result of the administration of a interscalene Exparel block versus the administration of an interscalene catheter for shoulder replacement surgery. The functional pain scale is a slightly more quantifiable measure of pain used in a diverse adult population to look at functional ability with pain. The Functional Pain Scale incorporates a "0" to "5" scale, with worsening pain being registered by higher numbers.

Time frame
The primary outcome will occur at 1 day after surgery date

Secondary outcomes

1

Pain Scores Assessed by functional pain scores on Post-operative day 7

Using electronic patient communications, the investigators will ask patients to report their functional pain score. The functional pain scale is a slightly more quantifiable measure of pain used in a diverse adult population to look at functional ability with pain. The Functional Pain Scale incorporates a "0" to "5" scale, with worsening pain being registered by higher numbers.

Time frame
Seven days after surgery date
2

Pain Scores Assessed by functional pain scores on Post-operative day 30

Using electronic patient communications, the investigators will ask patients to report their functional pain score. The functional pain scale is a slightly more quantifiable measure of pain used in a diverse adult population to look at functional ability with pain. The Functional Pain Scale incorporates a "0" to "5" scale, with worsening pain being registered by higher numbers.

Time frame
At 30 days after surgery date
3

Pain Scores Assessed by functional pain scores on Post-operative day 90

Using electronic patient communications, the investigators will ask patients to report their functional pain score. The functional pain scale is a slightly more quantifiable measure of pain used in a diverse adult population to look at functional ability with pain. The Functional Pain Scale incorporates a "0" to "5" scale, with worsening pain being registered by higher numbers.

Time frame
At 90 days after surgery date
4

Measurement of the narcotics used to control pain (PACU)

The investigators will report the amount of narcotics required (converted to morphine milliequivalents) while subject remains in the Post Anesthesia Care Unit (PACU).

Time frame
Up to 2 hours in Post-Operative Recovery Unit

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Melinda Seering

Lead sponsor

University of Iowa

Sponsor institution

Source ClinicalTrials.gov
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