Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement
|ClinicalTrials.gov Identifier: NCT00895531|
Recruitment Status : Terminated (Investigator left institution)
First Posted : May 8, 2009
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Arthroplasty, Replacement, Knee||Drug: Depodur Procedure: sciatic nerve block||Phase 4|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Comparison of Peripheral Nerve Blocks vs. Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement: A Prospective, Randomized Study|
|Study Start Date :||December 2009|
|Primary Completion Date :||December 2012|
|Study Completion Date :||December 2012|
Active Comparator: Peripheral Nerve group
Group will receive sciatic catheter placed before or after surgery by subgluteal approach with the use of ultrasound. The ischial tuberosity will be identified with the ultrasound probe and its midpoint marked. A catheter will be inserted and placed perineurally. If placed preoperatively, the catheter will be flushed with normal saline or 5% dextrose and will not be dosed until after surgery. After the patient is in the PACU and the surgeons have verified the sciatic nerve function, the sciatic catheter will be dosed with 35 mL 0.25% ropivacaine.
Procedure: sciatic nerve block
The sciatic nerve will be identified at the subgluteal level with ultrasound. A point 3 cm lateral and 4 cm caudad will be marked. Patients will be placed in the lateral position. A 18 G Tuohy needle will be inserted at a 45° angle until a peroneal or tibial twitch is obtained at 1.5 mA. Once the current can be reduced to obtain a twitch less than 0.5 mA, a catheter will be inserted and placed perineurally. If placed preoperatively, the catheter will be flushed with normal saline or 5% dextrose and will not be dosed until after surgery. After the patient is in the PACU and the surgeons have verified the sciatic nerve function, the sciatic catheter will be dosed with 35 mL 0.25% ropivacaine.
Other Name: Nerve block, sciatic
Experimental: Depodur Group
patients will have an L2-L3 epidural placed while they are in the sitting position before or after femoral catheter placement. They will receive 7.5 mg Depodur via the epidural catheter. All of these patients will receive Singular 10 mg and Claritin 10 mg before the epidural Depodur is placed, as per our protocol of patients receiving EREM.
7.5 mg Depodur via the epidural catheter
Other Name: morphine sulfate extended-release liposome injection
- Postoperative Pain [ Time Frame: 48 hours ]Pain as reported on a verbal rating scale ( VRS) (0-10, 0 = no pain, 10 = worse pain imaginable).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00895531
|United States, Kentucky|
|University of Louisville Hospital|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||Anupama Wadhwa, MD||University of Louisville|