The notice to patients was part of a recent announcement by the FDA warning health care professionals of the a painful and debilitating condition known as chondrolysis reported in patients who have had surgery followed by continuously infused local anesthetics for 48 to 72 hours through a pain pump device. The anesthetics involved are marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine and ropivacaine.

While the local anesthetics are approved by the FDA 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 pain pump devices, or elastomeric pumps.

Chondrolysis was diagnosed within a median of 8.5 months after infusion. Almost all of the reported cases (97 percent) occurred following shoulder surgeries. Joint pain, stiffness and loss of motion were reported as early as the second month after receiving the infusion. In more than half of these reports, the patients required additional surgery, including arthroscopy or arthroplasty, also known as joint replacement.

The numerous reported cases of chondrolysis following use of intra-articular infusion with local anesthetics has prompted the FDA to require the drug manufacturers to update their product labels to warn healthcare professionals about the potential serious adverse effect.

SOURCE: Pain Pumps › Orthopedic surgery patients urged to monitor symptoms

A recent study published in The American Journal of Sports Medicine first brought to light the connection between chondrolysis, a condition in which the cartilage has been eroded away, and the use of pain pumps during and following surgery. This type of chondrolysis, characterized by the complete loss of articular cartilage from the humeral head and glenoid, has been associated with intra-articular injection of dye, and with the post-arthroscopy infusion of local anesthetic into the joint.

Sixty-six cases of chondrolysis associated with shoulder arthroscopy followed by the intra-articular pain pumps with local anesthetic were identified among men and women between the ages of 15 and 57. Fifty-five of those patients had normal joint surfaces at the time of arthroscopy. All patients who suffered from chondrolysis suffered from pain and loss of motion that began between 91 to 1,650 days following surgery.

While pain pumps are approved by the Food and Drug Administration (FDA) to deliver pain medication into the shoulder tissue, they are not approved for use with the catheters placed directly in the joint space, as pain pump manufacturers had instructed surgeons. It is believed this non-approved practice led the anesthetic to erode the cartilage in the shoulder.

SOURCE: Pain Pumps › Surgeons discuss characteristics of chondrolysis caused by pain pumps