Orthopedic and anesthesia healthcare professionals and hospital risk managers are being advised by the U.S. Food and Drug Administration (FDA) of 35 reports of chondrolysis—cartilage necrosis and destruction—in patients given continuous, intra-articular infusions of local anesthetics with elastomeric pain pumps used to control pain after joint surgery. The anesthetics in question are marketed under the names bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine
The 35 reports occurred between 2006 and 2008 primarily in the shoulder (97%) and were received via the agency’s Adverse Event Reporting System (AERS). The remaining reports occurred in the knee. Four additional reports of chondrolysis in patients administered continuous intra-articular infusions of lidocaine in the shoulder were reported after the initial 35 bupivicaine-related cases were reported from 2006 to 2008, said the FDA.
Thirty-two (91%) patients received bupivacaine (with or without epinephrine) as an intra-articular infusion after undergoing arthroscopic and other surgical procedures. Two patients received ropivacaine in addition to bupivacaine and two received bupivacaine as a single injection along with an intra-articular infusion of lidocaine. The average infusion time was between 48 and 72 hours and the most commonly reported site of infusion was the glenohumeral (glenoid) space (46%). The most common manufacturer of elastomeric infusion device mentioned was Stryker; other manufacturers mentioned were I-flow, Donjoy, and Breg.
The local anesthetic was infused using an elastomeric pump. Joint pain, stiffness, and loss of motion were reported as early as the second month after infusion. In more than half of the reports, patients required additional surgery, including arthroscopy or arthroplasty. Arthroplasty is the medical term for joint replacement. Chondrolysis symptoms occurred as early as two months after the infusion and was diagnosed about eight and a-half months following infusion. Patients averaged about 25 years of age—the range was 16-to-58 years of age—with six involving pediatric patients between 16 and 18 years.
Sixteen of the 32 (50%) bupivacaine-associated AERS reports included the dose administered; 10 of 16 received 500mg over 48 hours or 250mg/day. While within the maximum dose listed in the drug label (400mg/day), the maximum labeled daily dose was determined for the approved, not off-label uses such as continuous intra-articular infusions with elastomeric infusion devices. Local anesthetics are approved as injections for the production of local or regional anesthesia or analgesia. The approved drug labels for local anesthetics do not include an indication for continuous intra-articular postoperative infusions or use of infusion devices, such as elastomeric pumps.
The FDA has not cleared any infusion devices with an indication for use in intra-articular infusion of local anesthetics. Health care professionals are urged to follow instructions for elastomeric infusion devices, and not use these devices for continuous intra-articular infusion of local anesthetics after orthopedic surgery. The FDA is also advising patients that, if, after an orthopedic surgical procedure, a prolonged infusion of a local anesthetic was administered into a joint using a disposable elastomeric pump or other infusion pump, to pay attention to joint pain, stiffness, and a decrease or loss of motion and contact a healthcare professional if symptoms persist.
The FDA is now requiring the manufacturers of local anesthetics and of pumps that may be used to infuse local anesthetics to update labels to warn healthcare professionals about this potential serious adverse effect. The reported cases involved significant injury to otherwise healthy young adults and the agency wants to advise healthcare professionals that elastomeric infusion devices or any other infusion pump are not cleared by FDA to deliver intra-articular infusions of local anesthetics and should not be used for this purpose.