If you've been among the more than 2 million women each year who go for the epidural to minimize discomfort (read: agony) during childbirth, you may wonder how something as painful as a medical-grade javelin being inserted in your back could actually reduce the pain of something so large, uh, coming out.
The fact is, having an epidural administered is relatively safe and, to some, the feeling is nothing more than a pin prick. However, even the most experienced anesthesiologists can't always determine the correct insertion point on the first try. So they have to try again.
And possibly, again.
The more times a body is poked, the more opportunity for an infection at the insertion point. And while the risks are very low, epidurals can indeed cause cause severe infections, post-dural puncture (or spinal) headaches, and other potentially serious and even fatal complications.
Bottom line: Few people enjoy needles and, therefore, hardly anyone will claim to relish repeated needles in the same spot as a result of being stuck in the wrong spot.
The good news for the more than 50 percent of laboring women who choose to receive an epidural is that the U.S. will soon welcome a new epidural procedure, one that provides anesthesiologists with "the ability to quantitatively determine and document the pressure at the needle tip in real time."
The U.S. Food and Drug Administration has awarded 510(k) clearance for marketing and sales of the CompuFlo Epidural Computer Controlled Anesthesia System (which basically means the FDA has given it a thumbs-up on safety and effectiveness).
With the new system, anesthesiologists will be provided with visual and audible in-tissue feedback when attempting to determine the optimal epidural insertion point. In a clinical study of 400 patients, the optimal epidural space had a 99 percent success rate of being correctly identified on the first attempt. Clinical and nonclinical tests found the CompuFlo Epidural device performs as well as or better than other similar procedures, so now the hope is that the new technique will reduce health risks to patients by avoiding loss of resistance during the process.
Compuflo gives anesthesiologists better aim.
The system is being touted by some as "the first real progress in this area since the invention of the syringe back in the 1860s." (We're not so sure about that, but still. A way better experience for many women.)
Dr. Mark Hochman, a dentist and the inventor the CompuFlo epidural, told Mom.me the majority of risks associated with epidural procedures are not getting the needle in the correct location. With Compuflo, though, Hochman says the "risk of adverse affects are greatly mitigated" due to the criteria he devised that enables physicians to find the correct location "with more objective certainty."
Meaning, Compuflo gives anesthesiologists better aim.
Current epidural administration techniques rely on a very subjective set of criteria that has a wide learning curve. And if there's one thing a laboring mom-to-be doesn't need, it's one more thing to worry about.
The FDA approval came on Monday, and now that CompuFlo can be marketed and sold in the United States, Hochman anticipates hospitals will start rolling it out over the next six months. Hochman is also the inventor of The Wand, which is a computer-assisted anesthesia system for dental procedures that has over 30,000 users worldwide and has resulted in 65 million injections.