Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion

NCT ID: NCT01108562

Last Updated: 2015-04-06

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

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Brief Summary

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This study will focus on patients undergoing total hip arthroplasty and Loma Linda University Medical Center \& East Campus. These patients will be randomized to receive a low dose lidocaine infusion or placebo, in addition to the patient controlled analgesia pump. These groups will be compared to one another statistically to determine which group shows the safest and most satisfying pain control.

Detailed Description

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Conditions

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Postoperative Pain Management After Total Hip Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Control Group

Patients will receive a Dilaudid PCA in combination with a placebo infusion of normal saline.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type OTHER

Patients in the control group will be receiving an infusion of normal saline for 24 hours postoperatively.

Lidocaine Group

Patients will be receive a Dilaudid PCA in combination with a continuous Lidocaine infusion.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Patients in the experimental group will be receiving a Lidocaine infusion at 1.33 mg/kg/hr for 24 hours postoperatively.

Interventions

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Lidocaine

Patients in the experimental group will be receiving a Lidocaine infusion at 1.33 mg/kg/hr for 24 hours postoperatively.

Intervention Type DRUG

Normal Saline

Patients in the control group will be receiving an infusion of normal saline for 24 hours postoperatively.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult male or female undergoing a total hip arthroplasty Subject is American Society of Anesthesiologists physical status 1, 2, or 3 Subject has voluntarily signed and dated the informed consent document approved by the IRB Be English speaking

Exclusion Criteria

* Age \> 80 years old or younger than 18 years old Congestive heart failure Hepatic insufficiency Neurological disorders Psychiatric disorders Steroid treatment No history of atrial fibrillation Chronic pain disorder with opioid treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charles Lee MD

UNKNOWN

Sponsor Role collaborator

Michelle Schlunt MD

UNKNOWN

Sponsor Role collaborator

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle L Schlunt, MD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University Medical Center

Other Identifiers

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57366

Identifier Type: -

Identifier Source: org_study_id

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