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Cases of chondrolysis diagnosed a median of 8.5 months after administration of a continuous intra-articular infusion of a local anesthetic for postsurgical pain with an infusion pump have prompted the Food and Drug Administration to issue a statement recommending against this practice.
“Because the reported cases involved significant injury to otherwise healthy young adults, the FDA wants to advise health care professionals that elastomeric infusion devices or any other infusion pump are not cleared by [the agency] to deliver intra-articular infusions of local anesthetics and should not be used for this purpose,” according to the statement, which lists bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, and ropivacaine as the marketed local anesthetics.
The statement also pointed out that local anesthetics are approved as injections “for the production of local or regional anesthesia or analgesia” and are not approved for continuous intra-articular postoperative infusions. “It is important to note that single intra-articular injections of local anesthetics in orthopedic procedures have been used for many years” without any reports of chondrolysis, the statement added.
The 35 reports of chondrolysis—the necrosis and destruction of cartilage—reviewed by the FDA were reported between 2006 and 2008 in people aged 16–58 years (median 25 years), mostly after shoulder surgery; 6 were in people aged 16–18. They were given continuous infusions of a local anesthetic over 48–72 hours, administered directly into the intra-articular space with an elastomeric infusion pump, with and without epinephrine. Of the 35 cases, 34 (97%) involved shoulder surgeries; the remaining case was in the knee. Almost half (46%) of the infusions involved the glenohumeral (glenoid) space. Most of the cases (32 or 91%) involved bupivacaine.
Symptoms of chondrolysis—joint pain, stiffness, and loss of motion—were reported as early as the second month after the infusion. In more than half of the cases, additional surgery, such as arthroscopy or joint replacement, was needed, according to the FDA. The cases were not associated with any single brand of infusion device.
Although the cause of the 35 cases is not known, “the infused local anesthetic drugs, the device materials, and/or other sources may have resulted in the development of chondrolysis,” the statement said. There have also been recent reports of chondrolysis in the literature of people who have had bupivacaine infusions, as well as preclinical studies that found that exposure of chondrocytes to bupivacaine, lidocaine, and ropivacaine resulted in chondrolysis.
Cases of chondrolysis diagnosed a median of 8.5 months after administration of a continuous intra-articular infusion of a local anesthetic for postsurgical pain with an infusion pump have prompted the Food and Drug Administration to issue a statement recommending against this practice.
“Because the reported cases involved significant injury to otherwise healthy young adults, the FDA wants to advise health care professionals that elastomeric infusion devices or any other infusion pump are not cleared by [the agency] to deliver intra-articular infusions of local anesthetics and should not be used for this purpose,” according to the statement, which lists bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, and ropivacaine as the marketed local anesthetics.
The statement also pointed out that local anesthetics are approved as injections “for the production of local or regional anesthesia or analgesia” and are not approved for continuous intra-articular postoperative infusions. “It is important to note that single intra-articular injections of local anesthetics in orthopedic procedures have been used for many years” without any reports of chondrolysis, the statement added.
The 35 reports of chondrolysis—the necrosis and destruction of cartilage—reviewed by the FDA were reported between 2006 and 2008 in people aged 16–58 years (median 25 years), mostly after shoulder surgery; 6 were in people aged 16–18. They were given continuous infusions of a local anesthetic over 48–72 hours, administered directly into the intra-articular space with an elastomeric infusion pump, with and without epinephrine. Of the 35 cases, 34 (97%) involved shoulder surgeries; the remaining case was in the knee. Almost half (46%) of the infusions involved the glenohumeral (glenoid) space. Most of the cases (32 or 91%) involved bupivacaine.
Symptoms of chondrolysis—joint pain, stiffness, and loss of motion—were reported as early as the second month after the infusion. In more than half of the cases, additional surgery, such as arthroscopy or joint replacement, was needed, according to the FDA. The cases were not associated with any single brand of infusion device.
Although the cause of the 35 cases is not known, “the infused local anesthetic drugs, the device materials, and/or other sources may have resulted in the development of chondrolysis,” the statement said. There have also been recent reports of chondrolysis in the literature of people who have had bupivacaine infusions, as well as preclinical studies that found that exposure of chondrocytes to bupivacaine, lidocaine, and ropivacaine resulted in chondrolysis.
Cases of chondrolysis diagnosed a median of 8.5 months after administration of a continuous intra-articular infusion of a local anesthetic for postsurgical pain with an infusion pump have prompted the Food and Drug Administration to issue a statement recommending against this practice.
“Because the reported cases involved significant injury to otherwise healthy young adults, the FDA wants to advise health care professionals that elastomeric infusion devices or any other infusion pump are not cleared by [the agency] to deliver intra-articular infusions of local anesthetics and should not be used for this purpose,” according to the statement, which lists bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, and ropivacaine as the marketed local anesthetics.
The statement also pointed out that local anesthetics are approved as injections “for the production of local or regional anesthesia or analgesia” and are not approved for continuous intra-articular postoperative infusions. “It is important to note that single intra-articular injections of local anesthetics in orthopedic procedures have been used for many years” without any reports of chondrolysis, the statement added.
The 35 reports of chondrolysis—the necrosis and destruction of cartilage—reviewed by the FDA were reported between 2006 and 2008 in people aged 16–58 years (median 25 years), mostly after shoulder surgery; 6 were in people aged 16–18. They were given continuous infusions of a local anesthetic over 48–72 hours, administered directly into the intra-articular space with an elastomeric infusion pump, with and without epinephrine. Of the 35 cases, 34 (97%) involved shoulder surgeries; the remaining case was in the knee. Almost half (46%) of the infusions involved the glenohumeral (glenoid) space. Most of the cases (32 or 91%) involved bupivacaine.
Symptoms of chondrolysis—joint pain, stiffness, and loss of motion—were reported as early as the second month after the infusion. In more than half of the cases, additional surgery, such as arthroscopy or joint replacement, was needed, according to the FDA. The cases were not associated with any single brand of infusion device.
Although the cause of the 35 cases is not known, “the infused local anesthetic drugs, the device materials, and/or other sources may have resulted in the development of chondrolysis,” the statement said. There have also been recent reports of chondrolysis in the literature of people who have had bupivacaine infusions, as well as preclinical studies that found that exposure of chondrocytes to bupivacaine, lidocaine, and ropivacaine resulted in chondrolysis.