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

• Sponsor: Loma Linda University (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT00616850
• Collaborator: (none)
• Enrollment: 0
• Location: 1
• Arms: 3
• Duration (Months): 21
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Total Knee Arthroplasty	Procedure: Continuous femoral catheter block; Drug: Lidocaine; Other: Preservative free normal saline	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• 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.
• Study Start Date: Oct 1, 2007
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group A Group A subjects will receive a continuous femoral block catheter and a Patient Controlled Analgesia (PCA).	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.
Experimental: Group B Group B subjects will receive a low dose lidocaine (1.33 mg/kg/hr) infusion and a Patient Controlled Analgesia.	Drug: Lidocaine; Lidocaine 1.33mg/kg/hr continuous IV infusion following induction of general anesthesia to 24 hours postoperatively.
Placebo Comparator: Group C Group C subjects will receive placebo (preservative free normal saline) infusion and a Patient Controlled Analgesia.	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.

Outcome Measures

Primary Outcome Measures

1. Total PCA opioid consumption [72 hours]

Secondary Outcome Measures

1. Time to first flatus [72 hours postoperatively]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University Medical Center	Loma Linda	California	United States	92354

Sponsors and Collaborators

• Loma Linda University

Investigators

• Principal Investigator: Michelle Schlunt, M.D., Loma Linda University Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Loma Linda University
• ClinicalTrials.gov Identifier: NCT00616850
• Other Study ID Numbers: 57175
• First Posted: Feb 15, 2008
• Last Update Posted: May 22, 2014
• Last Verified: May 1, 2014

• Keywords provided by Loma Linda University: Total Knee Arthroplasty; Intravenous Lidocaine Infusion; Femoral Block Catheter
• Additional relevant MeSH terms: Pain, Postoperative; Lidocaine

Study Results

No Results Posted as of May 22, 2014