Pharmaceutical

Health Canada issues warning about postoperative pain pumps

Health Canada has issued a statement encouraging health care professionals to follow instructions for use and refrain from using postoperative pain pumps for continuous intra-auricular infusion of local anesthetics – especially with epinephrine – after shoulder surgery.

Postoperative pain pumps are a pain-management system designed to deliver medication directly to the surgical wound or in close proximity to the nerves associated with the surgical area. A recent study published by The American Journal of Sports Medicine identified the post-operative pain pumps as the likely cause of articular chondrolysis, a progressive degeneration of the cartilage. Chondrolysis of the shoulder results in the narrowing of the joint space, which can cause pain and loss of motion. Chondrolysis is a chronic condition that often requires surgery.

As of July 2008, Health Canada had received eight reports of articular chondrolysis one month to one year following shoulder surgery. In all cases, the chondrolysis was thought to have been related to pain pumps. All patients listed in the incidence reports received bupivacaine, a local anesthetic, with epinephrine, a hormone and neurotransmitter.

Instructions for use on the label of the postoperative pain pumps discourages continuous intra-articular infusion of anesthetics, particularly when epinephrine is used.

In its announcement, Canada Health also urged health care professionals to report any adverse incidents following the use of pain pumps or other medical devices to the Health Products and Food Branch Inspectorate through the Inspectorate Hotline at 800-267-9675.