The Pain conditioner
What does the pain conditioner do ?
The pain conditioner is the single most effective device preventing the surgical damage of the cells lining the entire the abdominal cavity. These cells react to any trauma as absence of oxygen by the CO2 used for pneumoperitoneum in laparoscopic surgery, to desiccation and any other as fibrin and rinsing liquids. This reaction is fast and results in cell retraction and bulging and in acute inflammation. This causes pain and enhanced adhesions at the surgical trauma sites.
The Pain conditioner will change the gas environment during surgery by adding small amounts of laughing gas (N2O) and/or Oxygen to the CO2 used for the pneumoperitoneum.
How to use the Pain Conditioner
The Pain Conditioner is CE marked and approved for use. Installation requires to connect the pain conditioner to electricity and to the O2 and to the N2O outlet of the operating room.
The Pain Conditioner is placed after the CO2 insufflator for the pneumoperitoneum, and the outlet of the insufflator is connected to the inlet of the Pain Conditioner. The outlet of the Pain conditioner will go to the patient.
If inactive the device is an open stainless tube and will not modify the flow or the pressure of the CO2 insufflation.
When powered up Before and provided hours of user credit are inserted, the touch screen permits to choose the addition of 0%, 2% or 4% of O2 and/or 0%, 5% or 10% of N2O to the CO2 provided . This addition will not alter the insufflation pressure or the flow of CO2. Also the surgery itself will not be affected.
Contamination of the OR atmosphere with N2O should be avoided. Therefore aspiration should be used for desufflation of the pneumoperitoneum (similar to procedures in anesthesia). Leaks during surgery should be avoided and if unavoidable (e.g. open vagina during hysterectomy) the addition of N2O should be interrupted.
Safety of the Pain Conditioner.
The Pain Conditioner is extremely safe for the patient. The insufflation pressure and flow are those of the insufflator, without any changes.
N2O is a well known and safe gas widely used in anesthesia for over 50 years. It moreover has an higher solubility in water and an higher lung exchange capacity than CO2, and is therefore even slightly safer than CO2 concerning gas embolism. At the concentrations of 5% or 10% there is no explosion risk, which occurs only when concentrations exceed 30%. Resorption during surgery is limited and even after hours of pneumoperitoneum no N2O could be measured in the expiration of the patient.
O2 has a lower solubility in water but at 4% the risk of gas embolism is considered negligible.
Mechanically, the Pain conditioner has a triple level of safety and the device will shut down immediately when any malfunctioning is detected. Examples of malfunctioning are an insufflation pressure higher than 20mm of Hg, a N2O concentration over 20%, an O2 concentrations over 10%, or when the readings of the duplicated measurements of pressure, or of the added N2O or O2 differ by more than 10%. In addition a series of other potential problems such as an incoming pressure of N2O or O2 lower than 3 or higher than 8 bar, will indicated on the display.
Advantages of the Pain Conditioner for the patient
When the Pain Conditioner is used with 10% of N2O, the patient can expect to have less CO2 resorption during surgery, much less postoperative pain, less postoperative adhesions and an accelerated postoperative recovery. When N2O is used, no beneficial effect of O2 could be demonstrated upon the superficial layers .
This can be concluded from Randomized Clinical Trials in the human and extrapolated from animal experiments. N2O in concentrations of 5% to 10% indeed is the single most important prevention of postoperative acute inflammation which is the driving motor of postoperative pain and adhesion formation and which slows down recovery. Details can be found in the articles describing peritoneal conditioning in more detail. In summary, with full conditioning we recently demonstrated a decrease in postoperative pain from 6/10 VAS to 1/10, an almost complete absence of adhesions, and an accelerated recovery by absence of shoulder pain and shorter time to first flatus. It is expected that with the Pain Conditioner only, almost 100% of the pain effects will be obtained together with a decrease in adhesion formation of over 60%.
N2O will prevent CO2 diffusion in the deeper tissue layers and thus hypoxia, a phenomenon that increases with the duration of surgery. The addition 4% of O2 is an additional safety to prevent hypoxia of deeper layers. It is expected that this will prevent damage to the ovarian reserve following ovarian surgery and a decreased risk of late bowel leaks following bowel surgery.
It is expected that the faster recovery, the decrease in postoperative pain, the decreased adhesion formation and the prevention of late bowel leaks and of a decreased ovarian reserve will result in a substantial decrease in health care expenditures.
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