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

NCT00616850 | Withdrawn

• 1 other identifier: 57175
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Total Knee Arthroplasty

Keywords

Total Knee Arthroplasty; Intravenous Lidocaine Infusion; Femoral Block Catheter

Outcome Measures

Primary Outcomes (1)

• Total PCA opioid consumption

  72 hours

Secondary Outcomes (1)

• Time to first flatus

  72 hours postoperatively

Study Arms (3)

Group A

ACTIVE COMPARATOR

Group A subjects will receive a continuous femoral block catheter and a Patient Controlled Analgesia (PCA).

Procedure: Continuous femoral catheter block

Group B

EXPERIMENTAL

Group B subjects will receive a low dose lidocaine (1.33 mg/kg/hr) infusion and a Patient Controlled Analgesia.

Drug: Lidocaine

Group C

PLACEBO COMPARATOR

Group C subjects will receive placebo (preservative free normal saline) infusion and a Patient Controlled Analgesia.

Other: Preservative free normal saline

Interventions

Continuous femoral catheter block PROCEDURE

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

Group A

Lidocaine DRUG

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

Group B

Preservative free normal saline OTHER

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

Group C

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Undergoing a total knee arthroplasty
• Be American Society of Anesthesiologist physical status 1,2, or 3
• Be willing and capable of providing informed consent
• Be English speaking

You may not qualify if:

• Age greater than 80 years old or younger than 18 years old
• Congestive hear failure
• Hepatic insufficiency
• Neurological disorders
• Psychiatric disorders
• Steroid treatment
• History of atrial fibrillation
• Chronic pain disorder with opioid treatment

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Michelle Schlunt, M.D.

  Loma Linda University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 15, 2008
• Study Start: October 1, 2007
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2009
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (1)