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Effect of Local Anesthetic Dose on Interscalene Block

NCT ID: NCT01701115

Last Updated: 2017-10-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-08-31

Brief Summary

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The purpose of this study is to determine if a decrease in the standard volume of local anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate anesthesia for the procedure and decrease the amount of time until you are ready for discharge from the hospital.

Detailed Description

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Traditionally, an interscalene block is done either with nerve stimulator or ultrasound guided using 40-60mL of local anesthetic. The study plans to investigate the difference in hand grip strength post-operatively in patients who will receive interscalene blocks with 40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve adequate surgical anesthesia while creating less motor block and thus, increase patient satisfaction, present fewer complications or adverse affects and decrease time in the recovery room.

Conditions

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Shoulder Arthroscopy Interscalene Block

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Low Dose (20 mL) Local Anesthetic

Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.

Group Type EXPERIMENTAL

Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block

Intervention Type PROCEDURE

Anesthetic volume:

Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL

Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)

Intervention Type DRUG

Control Dose (40 mL) Local Anesthetic

Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine

Group Type ACTIVE_COMPARATOR

Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block

Intervention Type PROCEDURE

Anesthetic volume:

Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL

Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)

Intervention Type DRUG

Interventions

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Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block

Anesthetic volume:

Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL

Intervention Type PROCEDURE

Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block

Anesthetic volume:

Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL

Intervention Type PROCEDURE

Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)

Intervention Type DRUG

Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)

Intervention Type DRUG

Other Intervention Names

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Mepivacaine Bupivacaine Mepivacaine Bupivacaine

Eligibility Criteria

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Inclusion Criteria

* Age: 18 - 80 years old
* Surgical time \< 2.5 hours
* ASA I, II or III
* Shoulder arthroscopy

Exclusion Criteria

* Age \< 18 or \> 80 years old
* Chronic pain patients (on narcotics/opioids \> 3 months)
* Open shoulder surgical procedure
* BMI \> 40
* Pre-existing neurological condition
* Patient refusal of interscalene block
* Severe respiratory disease or hemidiaphragmatic dysfunction
* Allergy to any local anesthetics
* Planned general anesthesia
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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2012-011

Identifier Type: -

Identifier Source: org_study_id