The Long Journey to the Aftermath of Pain Pump Induced Shoulder Joint Chondrolysis

Armand Rossetti

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Several companies, including Stryker, BREG, Inc., I-Flow and DJO, Inc. have manufactured and distributed high volume pain pumps. During surgery and for up to three days post, surgeons may use a variety of pain pumps to deliver anesthesia to the Glenohumeral (shoulder) joint space. The pain pumps have catheters that surgeons can implant, in nerve rich areas right inside the joint space. The pumps are ambulatory and usually disposable.

Generally, shoulder pain pumps are complementary to arthroscopic surgery (the catheter is inserted in a like manner), and installation is a relatively simple procedure. In fact, some physicians have

.

Physicians have considered pain pump therapy

, and they promptly warned manufacturers about the problem. Surprisingly, those manufacturers took nearly three years to respond with suitable warnings to doctors and consumers. Meanwhile, surgeons kept recommending pain pumps to their patients, and they continued using those devices.

Before continuing further, let’s take a look at shoulder anatomy using the following videos:

; and

.

THE ARTHROSCOPIC PROCEDURE

As recently as two decades ago, physicians were using open surgery to treat shoulder joint disease. Today, most surgeons employ arthroscopy to treat joint injuries as simply and effectively. The word arthroscopy derives from the Greek words “arthro” (joint) and “skopein” (to look); meaning to look within the joint.

Here is a brief look at what takes place [

].

As you have just seen by viewing the two preceding arthroscopic videos, rather than making large incision and exposing a joint, current technology enables surgeons to make much smaller incisions, insert pencil sized instruments that contain fiber optic lighting for illumination, and to introduce a miniature TV camera to aid in visualizing the operative site.

In the process of repairing a shoulder injury, surgeons may employ arthroscopy in the following way [

].

As you can see, arthroscopic surgery minimizes damage to surrounding tissue, enables a shorter healing period, and promotes a more favorable long term prognosis. However arthroscopic surgery does not eliminate the need for local anesthesia both during and after surgery, and this is where the shoulder pain pump has conveniently served a purpose.

PROBLEMS WITH THE PAIN PUMP

During several years that surgeons were treating a sizeable number of patients with shoulder joint injuries, the results were to be predictable and the outcome

. Here are photos of some available pain pump brands:

1. Stryker Corporation:

PainPump with Disposable Syringe Infuser;

PainPump 2; and;

PainPump Blockade.

2. I-Flow, Inc.:

On-Q Painbuster.

Here is another view of the On-Q.

3. BREG, Inc.

Pain Care 2000.

After placing a number of these pain pumps, practitioners began to see patients coming back to the clinic with a rare condition known as Postarthroscopic Glenohumeral Chondrolysis (PAGCL). Literally, PAGCL means a breakdown of the cartilage that lies between the shoulder’s ball and socket forming the joint. This sudden rise in an otherwise very rare disease led investigators to review surgical records of groups of patients who had recently undergone arthroscopic shoulder surgery with no resulting damage to the cartilage during surgery. As a result, the following concerns in need of explanations have surfaced:

CAUSATION

General Toxicity and lengthened exposure

In August 2006, the following investigators, Andreas Gomoll, Richard Kang, et al., warned that Bupivacaine in itself was toxic to chondrocytes and that the use of 48 hour therapy with pain pumps greatly magnified chondrocyte injury.

Gomoll and Kang concluded the following:

"[T]ests showed significant detrimental changes in articular cartilage after infusion of bupivacaine with or without epinephrine; confocal laser microscopy showed that treatment with bupivacaine with epinephrine and bupivacaine without epinephrine reduced cell viability by 20% and 32%, respectively. More importantly, sulfate uptake, as an indirect measure of proteoglycan synthesis, was suppressed even further, by 56% and 50%, respectively, compared with saline solution. The comparatively larger reduction in sulfate uptake than in cell viability suggests that even cells that survived after bupivacaine infusion remained at a decreased metabolic state 5 days after cessation of the infusion."

Use of Certain Anesthetic Drugs

Drs. Brent Hansen and Charles Beck reviewed 177 arthroscopic shoulder surgeries, published their paper in American Journal of Sports Medicine, and concluded the following:

“There is a strong association between PAGCL and pain pumps used for delivering an anesthetic called bupivicaine combined with a blood vessel constrictor called epinephrine. It is possible that bupivicaine’s acidity measurement (pH), which lies between 3.5 and 5.5, may play a role in the onset of PAGCL.”

There is likelihood that other unrecognized factors might also be involved, such as thermal and/or radiofrequency, suture material, and reabsorbable suture anchors. However investigators did not find such evidence in the study. While further investigation is warranted, investigators have ruled out accompanying operative procedures, such as glycine lavage, Ringer’s lactate, electrocautery as contributory causes.

Until further investigation concerning pain pump related PAGCL takes place, investigators have advised surgeons and patients to avoid using pain pumps in combination with bupivicaine, with or without epinephrine, in all joints having an intact cartilage surface."

Catheter Placement

In response to Dr. Hansen’s study, pump manufacturer, I-Flow, finally issued a warning in its revised directions for use of its On-Q brand pain pump:

“Avoid placing the catheter in joint spaces. Although there is no definitive established causal relationship, some literature has shown a possible association between intraarticular infusions and the subsequent development of Chondrolysis.” (See paragraph 3).

FAILURE TO TIMELY WARN

Dr. Charles Beck who co-authored the Hansen study warned doctors, immediately, that shoulder pain pumps can cause permanent shoulder damage, and Dr. Beck reported that hundreds of people were at risk for developing PAGCL. Although Dr. Beck sent results of the study to manufacturers two years before its publication in October 2007, those manufacturers did not timely respond to the study. Therefore, manufacturers knew that there was a high likelihood that pain pump therapy problems existed in 2005. However, those manufacturers failed to take any action to warn doctors or the public of that high probability until 2008.

ALLEVIATING THE INJURIES THAT RESULT FROM PAIN PUMP THERAPY

Symptoms of PAGCL include:

• A reduction of the joint space in the shoulder
• Shoulder stiffness or weakness
• Underlying shoulder pain, whether at motion or at rest
• Grinding of the shoulder joint with clicking or popping
• Decreased range of motion

To alleviate those injuries, patients usually require Shoulder arthroplasty to replace the shoulder joint with synthetic parts. Those readers who are interested in seeing a comprehensive video, showing the two hour long reconstructive surgery that a pain pump victim might have to undergo, can view it here.

THE AFTERMATH

Unfortunately, there is no currently effective palliative treatment for 63% of the patients who contract PAGCL after using a shoulder pain pump. In many cases, unless patients elect to have their surgeons take heroic measures; patients suffering with PAGCL will have to endure a lifetime of debilitating pain and discomfort.