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

Postoperative Pain Management After Total Hip Arthroplasty Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01108562
• Other study ID #: 57366
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: April 20, 2010
• Last updated: April 2, 2015
• Start date: February 2008

Study information

• Verified date: April 2015
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain Management After Total Hip Arthroplasty

Intervention

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

Other:
• Normal Saline
Patients in the control group will be receiving an infusion of normal saline for 24 hours postoperatively.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Loma Linda University	Charles Lee MD, Michelle Schlunt MD

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No