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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This study has been withdrawn prior to enrollment.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:
Collaborators:
Charles Lee MD
Michelle Schlunt MD
Information provided by:
Loma Linda University
ClinicalTrials.gov Identifier:
NCT01108562
First received: April 20, 2010
Last updated: September 10, 2010
Last verified: September 2010
History of Changes
  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
Endpoint Classification: Efficacy Study
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 110
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

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Michelle Schlunt MD
ClinicalTrials.gov Identifier: NCT01108562     History of Changes
Other Study ID Numbers: 57366
Study First Received: April 20, 2010
Last Updated: September 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Loma Linda University:
postoperative pain management

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
 Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 23, 2013