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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Postoperative Pain Management After Total Hip Arthroplasty
• Intervention / Treatment: Other: Normal Saline; Drug: Lidocaine

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	24 hours

Collaborators and Investigators

• Sponsor: Loma Linda University
• Collaborators: Charles Lee MD; Michelle Schlunt MD
• Investigators: Principal Investigator: Michelle L Schlunt, MD, Loma Linda University Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Anticipated): August 1, 2008

Study Registration Dates

• First Submitted: April 20, 2010
• First Submitted That Met QC Criteria: April 20, 2010
• First Posted (Estimate): April 22, 2010

Study Record Updates

• Last Update Posted (Estimate): April 6, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: postoperative pain management
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 57366