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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01108562
First Posted: April 22, 2010
Last Update Posted: April 6, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Charles Lee MD
Michelle Schlunt MD
Information provided by (Responsible Party):
Loma Linda University
  Purpose
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.

Condition Intervention Phase
Postoperative Pain Management After Total Hip Arthroplasty Drug: Lidocaine Other: Normal Saline Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion in Combination With Patient Controlled Analgesia: a Prospective Randomized, Double-blinded, Placebo-controlled Study

Resource links provided by NLM:


Further study details as provided by Loma Linda University:

Primary Outcome Measures:
  • We propose to test the hypothesis that adding a low dose lidocaine infusion to patient controlled analgesia will lower the amount of opioids that these patients will receive, thereby improving patient safety while still providing adequate analgesia. [ Time Frame: 24 hours ]

Enrollment: 0
Study Start Date: February 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Group
Patients will receive a Dilaudid PCA in combination with a placebo infusion of normal saline.
Other: Normal Saline
Patients in the control group will be receiving an infusion of normal saline for 24 hours postoperatively.
Experimental: Lidocaine Group
Patients will be receive a Dilaudid PCA in combination with a continuous Lidocaine infusion.
Drug: Lidocaine
Patients in the experimental group will be receiving a Lidocaine infusion at 1.33 mg/kg/hr for 24 hours postoperatively.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01108562


Sponsors and Collaborators
Loma Linda University
Charles Lee MD
Michelle Schlunt MD
Investigators
Principal Investigator: Michelle L Schlunt, MD Loma Linda University Medical Center
  More Information

Responsible Party: Loma Linda University
ClinicalTrials.gov Identifier: NCT01108562     History of Changes
Other Study ID Numbers: 57366
First Submitted: April 20, 2010
First Posted: April 22, 2010
Last Update Posted: April 6, 2015
Last Verified: April 2015

Keywords provided by Loma Linda University:
postoperative pain management

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action