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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-10-31

Study Completion Date

2009-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Total Knee Arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group A

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

Group Type ACTIVE_COMPARATOR

Continuous femoral catheter block

Intervention Type PROCEDURE

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

Group B

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

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

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

Group C

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

Group Type PLACEBO_COMPARATOR

Preservative free normal saline

Intervention Type OTHER

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

Interventions

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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.

Intervention Type PROCEDURE

Lidocaine

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

Intervention Type DRUG

Preservative free normal saline

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No