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Exparel for Postoperative Pain Management in Shoulder Surgery

NCT ID: NCT02472314

Last Updated: 2023-12-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.

Detailed Description

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liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and faster return to function compared to current standard of care pain management for patients undergoing shoulder arthroplasty and shoulder surgery for proximal humerus fractures.

Conditions

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Fracture of Shoulder and Upper Arm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Liposomal Bupivacaine A

One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty

Group Type EXPERIMENTAL

1.3% Liposomal Bupivacaine

Intervention Type DRUG

local tissue infiltration of Liposomal Bupivacaine during surgery

CISB control for A

Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .

Group Type ACTIVE_COMPARATOR

0.125% Bupivacaine

Intervention Type DRUG

Continues nerve block with Bupivacaine during surgery and postoperatively

Liposomal Bupivacaine B

One time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation

Group Type EXPERIMENTAL

1.3% Liposomal Bupivacaine

Intervention Type DRUG

local tissue infiltration of Liposomal Bupivacaine during surgery

CISB control for B

Peripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation

Group Type ACTIVE_COMPARATOR

0.125% Bupivacaine

Intervention Type DRUG

Continues nerve block with Bupivacaine during surgery and postoperatively

Interventions

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1.3% Liposomal Bupivacaine

local tissue infiltration of Liposomal Bupivacaine during surgery

Intervention Type DRUG

0.125% Bupivacaine

Continues nerve block with Bupivacaine during surgery and postoperatively

Intervention Type DRUG

Other Intervention Names

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Exparel Bupivacaine

Eligibility Criteria

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Inclusion Criteria

* Patients undergoing shoulder arthroplasty under general anesthesia
* Patients undergoing open reduction internal fixation (ORIF) of a proximal humerus fracture under general anesthesia
* Patients with American Society of Anesthesiologist (ASA) physical status classification of 1-3
* Patients meeting criteria for standard of care continuous peripheral nerve block (CPNB) per anesthesia guidelines.
* Patients agreeing to be available for brief follow up telephone survey post- operatively and being mentally able to respond.
* Patients available for follow up routine post-operative clinic visits, per standard of care.

Exclusion Criteria

* Contraindications to regional anesthesia
* Significant peripheral neuropathy or neurological disorder affecting the upper extremity
* Contraindication to a component of multimodal analgesia
* Pregnancy
* Opioid tolerance
* Cognitive or psychiatric condition that might affect patient assessment and/or inability to provide informed consent.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wayne State University

OTHER

Sponsor Role lead

Responsible Party

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Vani J. Sabesan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Wayne State University Physician Group

Dearborn, Michigan, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2014-193

Identifier Type: -

Identifier Source: org_study_id