Back to resultsTreatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion
Primary Purpose
Postoperative Pain Management After Total Hip Arthroplasty
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Lidocaine
Normal Saline
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain Management After Total Hip Arthroplasty focused on measuring postoperative pain management
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control Group
Lidocaine Group
Arm Description
Patients will receive a Dilaudid PCA in combination with a placebo infusion of normal saline.
Patients will be receive a Dilaudid PCA in combination with a continuous Lidocaine infusion.
Outcomes
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01108562
First Posted
April 20, 2010
Last Updated
April 2, 2015
Sponsor
Loma Linda University
Collaborators
Charles Lee MD, Michelle Schlunt MD
1. Study Identification
Unique Protocol Identification Number
NCT01108562
Brief Title
Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Withdrawn
Study Start Date
February 2008 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
Collaborators
Charles Lee MD, Michelle Schlunt MD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain Management After Total Hip Arthroplasty
Keywords
postoperative pain management
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Patients will receive a Dilaudid PCA in combination with a placebo infusion of normal saline.
Arm Title
Lidocaine Group
Arm Type
Experimental
Arm Description
Patients will be receive a Dilaudid PCA in combination with a continuous Lidocaine infusion.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Patients in the experimental group will be receiving a Lidocaine infusion at 1.33 mg/kg/hr for 24 hours postoperatively.
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
Patients in the control group will be receiving an infusion of normal saline for 24 hours postoperatively.
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle L Schlunt, MD
Organizational Affiliation
Loma Linda University Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion
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