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Hyaluronidase products permitted for epidurolysis

Lisa on April 15, 2020 at 12:28 pm
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    • Lisa DybvikLisa
      Participant
      Joined: Aug 28, 2017
      Posts: 5
      #59090

      Dear Dr.Gabor Racz!
      My clinic is searching for hyaluronidase products for epidurolysis procedures. The most commonly used is Hylenex. What about other products like Hylase Dessau 150 IU or Hyalex 150 IU? All contain hyaluronidase 150 IU. Are there any special content requirements?

      Kindly regards,
      Lisa Dybvik
      Norway

      • Gabor B RaczGabor B Racz
        Participant
        Joined: Mar 28, 2016
        Posts: 30
        #59236

        Dear Lisa,

        The FDA does not allow differentiation of the products containing Hyaluronidase. However, we have written a couple of reviews, and I remember the royal pain of Hyaluronidase used sub-arachnoid used for the treatment of arachnoiditis, from a couple of Indian papers. These used skin testing of an animal extract. Compared to the purity of other proteinaceous animal extract hyaluronidases, the only alternative to me has been Hyalgan, which is a human recombinant synthetic Hyaluronidase. I usually take the 150 IU Hyalgan: for 1ml I dilute it in 10ml, preservative free, saline. I can use 5ml at two transforaminal injection with a curved blunt needle. I have never seen or heard of any complication for around 15 years of administration. The selection regarding anaphylactic reactions: Danny Moore, in 1957, published a study implicating Hyaluronidase in anaphylactic reaction to be 3%, but this has never been duplicated. I lectured to four to five hundred ophthalmic anesthesiologists, and asked how many used Hyaluronidase (all of them), how many does skin tests (none), how many have seen anaphylactic reactions (none.) Less than sufficiently scientific, but all of them, I believe, are significant. Currently, no publications recommends skin testing for anaphylactic reaction. Cost effectiveness is more convincing, especially in multiple blunt needle injections and multiple site injections such as codo or trans S1 catheter site for the scarring triangle. Plus, transforaminal, mid-canal epidural injections such as multi-level pathology, where it is simply the best outcome technique. The spreading impact of Hyaluronidase enhances transforaminal spread up and down the spinal canal.

        • Michael LepisMichael Lepis
          Participant
          Joined: Nov 7, 2015
          Posts: 2
          #59249

          Dear Dr. Racz

          In your opinion would replacing Hyalgan with supartz be ok since they are both preservative free and are obtained from the same source, Rooster Combs. Also when using a transforaminal approach for epidurolysis are you diluting the whole syringe of Hyalgan with 10ml preservative free, saline and than injecting 5ml into each location. Just trying to understand the process . Your feedback would be greatly appreciated.

          Sincerely,

          Michael Lepis, MD

            • Gabor B RaczGabor B Racz
              Participant
              Joined: Mar 28, 2016
              Posts: 30
              #59404

              To answer your question, yes. Five cc in the lumbar area. I strongly recommend you read the Collegial Communication article, not to be confused with my recent post:
              https://onlinelibrary.wiley.com/doi/abs/10.1111/papr.12057

              It was a trap; you have to be extra careful when you do a procedure between two fusions, above and below. A perfect epidural dye spread was followed by, in trying to place an epidural catheter with a subdural contrast reaching the sub-dural space. The patient developed pain, numbness, and weakness of one leg. This triggered my friend to call me, reaching me while the patient was still on the operating room table. He was able to text me X-Ray images taken of epidural followed by subdural spread. Persistent pain and weakness were some symptoms. Upon seeing the X-rays, I recognized that the pain, numbness, weakness was the result of compression of blood supply to the cord, and I recommended the patient to do a sit-up, and flex and rotate the torso. This enhanced the spread of the contrast in the subdural space, thus reducing the developed loculation pressure. By the time they reached the emergency room, the pain was less severe and started to move soon thereafter. The formerly weak, less and less responsive, foot drop. Subsequently recommended continuous movement; the MRI that was taken ASAP did not show any surgical lesion. The patient was kept in the hospital overnight. About the only thing you could do is to administer some intravenous steroids, but he already had steroids administered to the subdural space. He made a complete recovery, and we reported the event with some artist’s drawings and copies of the texted fluoroscopy pictures.

              This scenario was enacted many times, where one patient that had loculation, severe pain, and more injection of high concentration of local anesthetic did not help, but made matters worse. Following the phone call, within the few minutes of my recommendation of flexion rotation, the doctor responded in a few minutes with one word “Fantastic.” During the first medical legal case for following cervical neuroplasty, after surgical cutting of the greater occipital nerve, the patient in the recovery room started to complain of more severe pain, numbness, weakness. They were held back in the recovery room, hoping to manage the severe consequences of worsening pain. We did not have collegial communication, so the patient was discharged home. Overnight, they developed ipsilateral upper extremity paralysis. The following day, patient ended up with weakness, paralysis looking picture of the whole side of his body. The first group of lawyers withdrew from the case. After I prepared for the defense, five to six months post onset of hemipleygia, for the first time I was asked to write a chapter on medical legal cases involving neuroplasty/lysis of adhesion. I had to call Jim Rathmell whether he could give me a couple of weeks about what to do in such events. I have seen the need to distribute loculation, firmly etched in my mind that you simply have to do the flexion rotation in order to do what, eventually we understood, can best be described as duroplasty. After explaining the concept, he says “Yes! Hell, that is the only new thing in the book!” In the first publication on the flexion rotation, we mention the flexion of the torso enlarges the neural foramina, where fluid may escape. We also published a couple of cases that even hematomas can get better with the flexion rotation. The dural flossing, where at the flexion of the torso is followed by rotation of the head and neck, and flexing of the chin to shoulder left and right, moves the dural eight to twelve mm.

              Forgive me for the complexity of this case, but to understand we are talking about completely reversible to a major disaster. The spinal cord does not tolerate ischemia. Going back to hemipleygia look alike picture, which came before we understood how to reverse this condition; we had the dat documented when the patient developed the post procedure pain in the recovery room, and was managed with narcotics. The patient recovered the lower extremity weakness about five months later, with no residual deficit. A second group of lawyers picked up the case, and I was asked to continue the defense. My documentation of the flexion rotation, which we developed during the years of doing cervical neuroplasties. It became part of the cervical neuroplasty large series, with numerous publications on the topic. By the time we went to court, the patient virtually full recovered the upper extremity function/use, with possible weakness on pronation/supination. The explanation to the jury was that we just did not know exactly how to diagnose and treat cervical spinal loculation. The flexion rotation, leading to the exercise that we ended up naming as duroplasty, came through the recognition with the help of one of my patients who continued doing the repetitive flexion rotation and movement of dural until it separates the dural adhesions. The jury dismissed the case.

              There are few things that changed, for example, cord injury following transforaminal sharp needle interneural/interarterial injection leading to cord infarction. Since the publication by Scanlon, where the discussion of what to do in case of cord injury, he was the first one to report, “Use blunt needles!” Several other times mentioned, there have no been a single cord injury publication where curved blunt needles, with a second need used for delivery.

              The why, and what can happen, is a bit longer as you can tell. What is new: a rat injury model with lots of edema, hyaluronidase leads to rapid resolution of the edema. It prevents and reduced edema. Make sure you flex and rotate. Don’t forget Dural flossing!

              GBR

            • Lisa DybvikLisa
              Participant
              Joined: Aug 28, 2017
              Posts: 5
              #59361

              Drar Dr. Racz and Michael!
              Thank you very much for reply!
              Very helpful information.

              Sincerely,
              Lisa Dybvik

              • Gabor B RaczGabor B Racz
                Participant
                Joined: Mar 28, 2016
                Posts: 30
                #59405

                Thank you, Lisa. Don’t forget to call, not necessarily me, but anyone you trust and are friendly with. I’d be happy to take your call anytime.

                • Gabor B RaczGabor B Racz
                  Participant
                  Joined: Mar 28, 2016
                  Posts: 30
                  #59406

                  Feedback requested: do you like this format of response and engagement? Some might find it not to your liking, please let me know if you do prefer it.

                  Thank you,
                  GBR

                  • Lisa DybvikLisa
                    Participant
                    Joined: Aug 28, 2017
                    Posts: 5
                    #59421

                    Dear Racz,

                    Thank you very much for your answer. Yes I’m very satisfied with your answer and also very grateful that you are willing to give so much of your time to answer me like this.

                    Kind regards
                    Lisa

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