A Phase 2/3 interventional study of Bupivacaine Liposome Injection and Indwelling femoral nerve block in Osteoarthritis, Osteoarthritis, Knee and Arthritis, Degenerative, sponsored by United States Naval Medical Center, San Diego. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-10.
Sponsored by United States Naval Medical Center, San Diego · Phase 2/3, Interventional, and Treatment
The purpose of the study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain in primary total knee arthroplasty. The investigators hope to demonstrate equivalency of treatment modalities to provide an alternative to the commonly used treatment of femoral nerve blockade.
Postoperative pain control in total knee arthroplasty is generally managed by a multimodal approach of premedication, epidural and/or peripheral nerve blocks, narcotic medications, and anti-inflammatories. Multiple studies have evaluated the efficacy of anesthetic "cocktails" of various medications for local tissue infiltration to aide in controlling postoperative pain. A recent systematic review supported the use of local anesthetic infiltration in a single intraoperative dose as an adjunct to femoral nerve block in the relief of pain; with combinations of ropivacaine, ketorolac, and adrenaline providing the best results. Several studies noted decreases in opioid consumption and overall pain scores in the perioperative period.
A novel compound, liposomal bupivacaine (EXPAREL®, Pacira Pharmaceuticals, Inc., Parsippany, NJ, USA), has been proposed for use in total knee arthroplasty. To our knowledge, only one randomized controlled trial involving use of this compound in total knee arthroplasty has been published and was performed as a phase two dose ranging trial comparing liposomal bupivacaine to bupivacaine HCl. No statistically significant difference between the two compounds was shown, but a trend towards benefit in short term pain control was shown with EXPAREL 532mg.
Our current pain management regimen utilizes the multimodal approach of neuraxial anesthesia, indwelling femoral nerve catheter, opioids, and anti-inflammatory medications. The regional anesthesia service manages postoperative pain while the indwelling femoral nerve catheter is in place. The epidural is utilized for early postoperative analgesia and thromboprophylaxis. The epidural is discontinued on post-operative day 1 and the femoral nerve catheter is removed by the morning of postoperative day 3. Although femoral nerve catheters provide excellent pain control following TKA, there are associated disadvantages. Most notably there is inherent quadriceps weakness which places the patient at increased fall risk. To reduce the risk of falling, patients must wear a knee immobilizer with ambulation until the catheter is removed and quadriceps function has returned. This may delay the ability to actively participate in physical therapy.
The purpose of our present study is to evaluate the efficacy of local infiltration of liposomal bupivacaine versus use of an indwelling femoral peripheral nerve block in controlling early postoperative pain. The investigators aim to show equivalency between the two treatment modalities. Our hypothesis is that a systematic local infiltration of liposomal bupivacaine provided intraoperatively is equally efficacious as femoral indwelling peripheral nerve blockade in immediate postoperative pain control with more rapid progression with physical therapy.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
Browse Osteoarthritis studies →United States Naval Medical Center, San Diego is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
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Exclusion Criteria:
Femoral nerve block delivered via indwelling femoral nerve catheter
Drug: Indwelling femoral nerve block
Intraoperative intracapsular injection of bupivacaine liposome
Drug: Bupivacaine Liposome Injection
Intraoperative intracapsular injection of 266mg of bupivacaine liposome injection diluted to 60mL with 0.9% normal saline.
Also known as: EXPAREL
Femoral nerve block delivered via indwelling femoral nerve catheter with 0.125% bupivacaine.
Visual Analog Pain Scale
10cm VAS scale completed by the patient at set intervals postoperatively
Time frame: 0-3 months
Oral and Intravenous Opioid Consumption
Oral and intravenous opioid use calculated in terms of morphine equivalents
Time frame: 0-5 days (during hospitalization)
Hospital for Special Surgery (HSS) Knee Scores
Standardized functional clinical score for knee symptoms
Time frame: 0-3 months
Length of Hospital Stay
Time frame: 0-5 days
Distance ambulated with physical therapy
Time frame: 0-5 days (during hospitalization)
Time to straight leg raise with physical therapy
Time to return of quadriceps function
Time frame: 0-5 days (during hospitalization)
Postoperative range of motion
Knee range of motion measure by physical therapy and in clinic
Time frame: 0-3 months
Postoperative complication rate
All intervention related complications for each arm of the study
Time frame: 0-3 months
Plasma bupivacaine concentrations
Plasma levels of bupivacaine monitored throughout hospital stay
Time frame: 0-5 days (during hospitalization)
This study is withdrawn, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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United States Naval Medical Center, San Diego