Lumbar Plexus Block for Postoperative Pain Control After Hip Arthroscopy. A Randomized Controlled Trial

NCT ID: NCT01286805

Last Updated: 2013-06-05

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-05-31

Brief Summary

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The purpose of this study is to determine whether the use of a lumbar plexus block for arthroscopic hip surgery is superior to oral and intravenous opioid pain medications alone in treating pain. In addition, the study will examine whether lumbar plexus blocks reduce the total amount of pain medication needed, and therefore reduce the side effects of these medicines and increase patient satisfaction. It is hypothesized that addition of the lumbar plexus block will significantly reduce patients' postoperative pain.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Lumbar Plexus Blockade + CSE

The study group will receive a lumbar plexus blockade with 30 mL of 0.25% bupivacaine with 1:200,000 epinephrine, followed by a combined spinal-epidural.

Group Type EXPERIMENTAL

Lumbar Plexus Blockade

Intervention Type PROCEDURE

The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine

Control Group

The control group will receive only a combined spinal-epidural.

Group Type PLACEBO_COMPARATOR

Control

Intervention Type PROCEDURE

The control group will receive only a combined spinal-epidural.

Interventions

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Lumbar Plexus Blockade

The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine

Intervention Type PROCEDURE

Control

The control group will receive only a combined spinal-epidural.

Intervention Type PROCEDURE

Other Intervention Names

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Marcaine

Eligibility Criteria

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Inclusion Criteria

* American Society of Anesthesiologists (ASA) Class 1-3
* Patients aged 18 to 65 years
* Patients scheduled for primary, unilateral arthroscopic hip surgery by Dr. Kelly, Dr. Coleman, or Dr. Anil Ranawat
* Planned use of neuraxial anesthesia
* Body Mass Index less than 35
* Ability to follow study protocol

Exclusion Criteria

* Chronic opioid use (defined as daily or almost daily use of opioids for \>3 months)
* Contraindication to combined spinal-epidural anesthesia including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
* Contraindication to lumbar plexus block including but not limited to bleeding disorder, use of clinically relevant anticoagulant or antiplatelet medications, and anatomic abnormalities.
* Infection at the injection site(s)
* Allergy to any of the study medications
* Contraindication to a short course of NSAIDs (renal failure, intolerance)
* ASA Class 4-5
* Patient refusal
* Patients younger than 18 years old and older than 65
* Patients with any known indwelling hardware of the lumbar spine.
* Patients with a peripheral neuropathy of the surgical extremity
* Non-English speaking patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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New York Presbyterian Hospital

OTHER

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques T YaDeau, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

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Hospital for Special Surgery

New York, New York, United States

Site Status

New York Presbyterian Hospital

New York, New York, United States

Site Status

Countries

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United States

Related Links

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http://www.hss.edu

This is the link for the Hospital for Special Surgery website

Other Identifiers

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10038

Identifier Type: -

Identifier Source: org_study_id

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