Status:
TERMINATED
Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement
Lead Sponsor:
University of Louisville
Collaborating Sponsors:
EKR Therapeutics, Inc
Conditions:
Arthroplasty, Replacement, Knee
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 sci...
Detailed Description
After obtaining written informed consent, all patients will be sedated with 1-5 mg midazolam and up to 100 mcg fentanyl before any procedure is performed. They will be attached to standard ASA monitor...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00895531
Start Date
December 1 2009
End Date
December 1 2012
Last Update
July 27 2017
Active Locations (1)
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1
University of Louisville Hospital
Louisville, Kentucky, United States, 40202