Arthroscopic Anterior Cruciate Ligament Reconstruction: A Comparison of Three Catheter Placement Positions

There will be 96 subjects recruited into this study. Based on power analysis for repeated
measures analysis of variance, the sample size required for this investigation is 24
subjects per group based on a 90% confidence interval and alpha of 0.05. There will be 24
subjects in Group 1 (intraarticular bupivicaine infusion only). There will be 24 subjects in
Group 2 (patellar tendon harvest site only with bupivicaine). There will be 24 subjects in
Group 3 (both intraarticular and patellar tendon harvest site with bupivicaine). There will
be 24 subjects in the control, Group 4 (intraarticular infusion physiologic saline only).
All patients will be recruited under the discretion of the principal investigator.

The primary outcome measure for this investigation will be the Postoperative Patient Diary.
This document records patient's subjective evaluations of pain, comfort, ability to sleep,
activity level and quality of life. The Postoperative Patient Diary will be administered
daily on the day of surgery and each morning and each evening before the patient retires for
3 postoperative days. All pain medications taken during the 3 days of the postoperative
evaluation will be recorded on the Postoperative Patient Diary.

The investigational treatment for this investigation is the use of a Pain Care 3000
continuous infusion regional anesthesia device and accepted pharmacologic modalities for the
control of postoperative pain with continuous infusion of a local anesthetic agent
(bupivicaine 0.5%) intraarticularly only (Group 1), at the patellar tendon harvest site
(Group 2) and combined continuous infusion at the patellar tendon harvest site and
intraarticular infusion (Group 3).

Patients randomly assigned to the control group (Group 4) will receive intraarticular
infusion physiologic saline only.

The catheter delivers 2 cc of bupivicaine 0.5% per hour total. In patients in Group 3, with
2 catheters (1 in the patellar tendon harvest site and 1 intraarticular infusion), the
catheters are connected by a "Y" connector. The dosage of bupivicaine will be split among
the two sites.

The device does not allow delivery of more than 2 cc per hour. The patient cannot adjust or
alter the flow rate.

A standard general anesthetic protocol will be employed at the discretion of the supervising
anesthesiologist.

Prior to surgery, all patients will be instructed on both the use of the continuous infusion
device and on the methods for completing the study questionnaires. Catheters will be placed
at the end of the surgical procedure according to the randomization schedule. Patients will
then complete the study questionnaires on the day of surgery and on three consecutive days
following surgery.

The clinical evaluation will last 3 postoperative days. During the postoperative period,
sufficient additional pain medications will be available to all patients to sufficiently
control postoperative pain.

No analgesics or local anesthetics, other than those specified should be taken during the
postoperative period by any subject. Other medications such as "rescue analgesics"
considered to be necessary to the patient's welfare will be given at the discretion of the
principal investigator. If the medication provided is for pain relief, the patient must
request it. The administration of all medication, from premedication until discharge from
the hospital, must be recorded in the patient diary if it has a direct bearing on the study
outcome. Any medication taken for pain following hospital discharge within the established
post discharge follow up period must be recorded in the patient diary.

The investigator is responsible for assuring that there are procedures and expertise
available to cope with medical emergencies that may occur during the study. In case of
emergency, symptomatic treatment will be provided according to hospital routine. The reason
for the emergency may constitute a serious adverse event.

After surgery, a patient would be discontinued from the study if it is discovered that they
show a previously unrecognized allergy to the medication (bupivicaine). This would be rare.
If it occurs, the catheter would be immediately removed, thus ending the infusion of the
medication and the patient would no longer participate in the study.

Standard of Care Procedures:

Opioid based analgesics or their derivatives have been the standard of care in managing
postoperative pain for this procedure. These medications have been administered orally,
intramuscularly, or intravenously. There is no difference in the surgical procedure except
for the insertion of the catheter at the surgical site upon closure of the surgical wound.
All patients will receive Toradol 30 mg parenterally q6h x2, followed by Toradol 10 mg PO
QID for 3 days. This anti-inflammatory has an analgesic effect and is not used prn. Any
narcotic is used only as needed and the use of this will be tracked for this study.

All patients (including those in the study) will be kept in the hospital overnight following
surgery and will receive a patient controlled analgesia (PCA) device for intravenous
administration of morphine through the night of the hospital stay. Morphine usage during
this period will be recorded.

Patients undergoing this knee surgery are admitted to the 23 hour unit, stay overnight, and
are discharged the following morning usually before 10:00 am. This is the standard of care
and will be the same for those participating in the study.

Inclusion Criteria:

- Subject symptoms

1. Daily pain

2. Pain restricts work, recreation and/or activities of daily living (ADL)

- Cognitive function sufficient to understand protocol and to complete subject diary or
other analysis tools employed.

- Must read, write, and understand the English language.

- American Society of Anesthesiologists (ASA) risk 1 or 2

- Gender - Both

- Age 15 - 65 years (parental consent will be obtained on all subjects under age 18).

- Provided written informed consent

Exclusion Criteria:

- Neuropathic joint

- Remote source of ongoing sepsis

- Severe vascular disease

- Any medical condition precluding safe anesthesia, surgery, or rehabilitation

- Comorbid conditions preventing full functional activity or which require continuous
use of pain medication.

- A known history of allergy, sensitivity, or any other form of reaction to local
anesthetics of the amide type, acetaminophen, or opioids.

- Suspected inability to comply with study procedures, including language difficulties
or medical history and/or concomitant disease, as judged by the investigator.

- A neurological and/or vascular condition which may affect the outcome of the
procedure.

- Receiving regular treatment with analgesics, sedatives, or any other medication with
central nervous system effects.

- Tendency to bleed

- Women who are pregnant or are not practicing medically acceptable contraception (a
pregnancy test is used pre-operatively as part of standard of care).

- Participation in other clinical studies during this study or in the 14 days prior to
admission to this study.