Effective Pain Management of Interscalene Blocks During Shoulder Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2017-04-30

Brief Summary

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Shoulder replacement surgery is recognized as having the potential to cause a considerable amount of postoperative pain. Adequate management of pain after surgery is necessary not only to improve the patient's wellbeing but also to facilitate recovery. Several regional anesthesia techniques are available to combat postoperative pain in the shoulder replacement surgery patient, however, which method provides superior pain relief remains unknown. The purpose of this study is to examine the effectiveness of a continuous interscalene block versus a single shot interscalene block for postoperative pain relief in the shoulder replacement patient.

Patients undergoing shoulder replacement surgery will experience more effective pain relief with a continuous interscalene block versus and single shot interscalene block.

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Detailed Description

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This is a prospective randomized controlled trial. 76 patients receiving either primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement will be randomized to a regional anesthesia technique as part of their surgical procedure. 38 patients will receive a single shot interscalene block containing ropivicaine and 38 patients will receive a continuous interscalene block containing ropivicaine.

Conditions

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Primary Osteoarthritis, Unspecified Shoulder

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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Ropivacaine Single Shot Block

Single Shot Interscalene block patients will receive a single shot of 30ml of 0.5% Ropivacaine prior to surgery

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

The drug used for the interscalene blocks

Ropivacaine Continuous block

Continuous Interscalene block patients will receive a shot of up to 30ml of 0.5% Ropivacaine and then a catheter is placed. The catheter is secured with Dermabond and Tegaderm. Once surgery is complete, the catheter is connected to a pain ball system which holds 400ml of 0.2% Ropivacaine local anesthetic. The rate is locked in at 8ml/hr. Catheter is pulled once the pain ball is empty.

Group Type ACTIVE_COMPARATOR

Ropivacaine

Intervention Type DRUG

The drug used for the interscalene blocks

Interventions

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Ropivacaine

The drug used for the interscalene blocks

Intervention Type DRUG

Other Intervention Names

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Naropin

Eligibility Criteria

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Inclusion Criteria

* Surgical candidate for primary total shoulder replacement, hemiarthroplasty, or reverse total shoulder replacement
* patient must be 18 years or older and willing to sign and date an Institutional Review Board informed consent form, and
* must be able to understand and agree to follow study protocol.

Exclusion Criteria

* severe bronchopulmonary disease,
* oxygen dependent,
* existing nerve injury,
* BMI \> 40,
* coagulation disorders,
* allergy to ropivicaine,
* history of drug or alcohol abuse,
* American Academy of Anaesthesiologists physical status classification \> lll,
* pregnant women.

Eligible Sex

ALL

Accepts Healthy Volunteers

No