Treatment of Postoperative Pain After Total Knee Arthroplasy Using Intravenous Lidocaine Infusion

Total Knee Arthroplasty Clinical Trial

Official title:

Treatment of Postoperative Pain After Total Knee Arthroplasty Using Intravenous Lidocaine Infusion in Combination With Patient Controlled Analgesia Versus Continuous Femoral Block Catheter in Combination With Patient Controlled Analgesia: A Prospective, Randomized, Double-Blinded, Placebo-Controlled Study.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00616850
• Other study ID #: 57175
• Status: Withdrawn
• Phase: N/A
• First received: February 4, 2008
• Last updated: May 20, 2014
• Start date: October 2007
• Est. completion date: July 2009

Study information

• Verified date: May 2014
• Source: Loma Linda University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Total knee replacement is often associated with severe postoperative pain, especially in the first 24 hours. Patient controlled analgesia (PCA) and continuous femoral block with PCA are commonly used to treat postoperative pain after total knee arthroplasty. However, PCAs use opioids. Opioids are excellent painkillers but their use is hampered by side effects such as nausea, vomiting, bowel dysfunction, urinary retention, pruritus, sedation and respiratory depression. We propose to test the hypothesis that adding a low dose lidocaine infusion to PCAs will lower the amount of opioids that these patients receive, thereby improving patient safety while still providing adequate analgesia. In addition, continuous femoral block has been shown to provide superior postoperative pain control when compared to morphine PCA. Therefore, postoperative pain levels of study subjects will be compared to those subjects who receive a combination of a continuous femoral block catheter with a PCA.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2009
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Undergoing a total knee arthroplasty

2. Be American Society of Anesthesiologist physical status 1,2, or 3

3. Be willing and capable of providing informed consent

4. Be English speaking

Exclusion Criteria:

1. Age greater than 80 years old or younger than 18 years old

2. Congestive hear failure

3. Hepatic insufficiency

4. Neurological disorders

5. Psychiatric disorders

6. Steroid treatment

7. History of atrial fibrillation

8. Chronic pain disorder with opioid treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Total Knee Arthroplasty

Intervention

Procedure:
• Continuous femoral catheter block
A constant infusion of ropivacaine 0.2% without epinephrine will be given to each subject via continuous femoral catheter in Group A.

Drug:
• Lidocaine
Lidocaine 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.

Other:
• Preservative free normal saline
Preservative free normal saline 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.

Locations

Country	Name	City	State
United States	Loma Linda University Medical Center	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total PCA opioid consumption		72 hours	No
Secondary	Time to first flatus		72 hours postoperatively	No