Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators hypothesize that patients who receive a femoral catheter with low dose epidural Depodur will experience comparable or superior pain relief than those who receive both femoral and sciatic catheters. In addition, the investigators hypothesize that the one catheter will be less time consuming to place and facilitate early ambulation of the patient.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville
• Collaborator: EKR Therapeutics, Inc
• Treatments: Morphine

Criteria

Inclusion Criteria:

• Scheduled for total knee replacement or revision of total knee replacement

• Agree to have a regional technique including neuraxial analgesia for post-operative analgesia

• Be 18 to 70 years old

• Classified as ASA score I-III

Exclusion Criteria:

• Allergic to morphine

• Allergic to local anesthetics

• Been on opioids for more than 4 weeks

• Not willing to be randomized

• On anticoagulation medications that prevent placement of epidural

• Sensitive to effects of neuraxial opioids

• BMI>35

• Severe COPD

• Obstructive sleep apnea (OSA, see below). Each patient will be asked the questions below to determine their risk for OSA (STOP questionnaire). Patients who answer yes to 3 or more of the major criteria of the STOP questionnaire and have one of the minor criteria will be excluded from the study

STOP Questionnaire for OSA

Major Criteria:

S- Do you snore loudly (louder than talking or loud enough to be heard through closed doors)?

T-"Do you often feel tired, fatigued, or sleepy during daytime?

O-"Has anyone observed you stop breathing during your sleep?

P-"Do you have or are you being treated for high blood pressure?

Minor Criteria:

• BMI>35

• Age>50 yrs

• Neck Circumference>40 cm

• Male gender