Temperature and Pain in Laparoscopy
Condition: Intraoperative Temperature; Postoperative Pain; Laparoscopy
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this investigation is to assess the impact of forced air warming, warm humidified
      insufflation gas and the combination of the two on intraoperative temperature maintenance and
      the postoperative pain course as well as the fibrinolytic activity in peritoneal fluid
      following laparoscopic procedures (duration > 60 min) in a prospective, randomized,
      controlled, mono-centric study. Therefore 150 subjects will be randomized in 3 groups of 50
      subjects each. First group will be treated with forced-air warming blanket (bair hugger).
      Second group will be treated with warmed, humidified insufflation via the F&P HumiGard™
      Surgical Humidification System. Third group will be treated with both, warming blankets and
      warmed, humidified insufflation. The peri-operative temperature of patients might be higher
      in patients of the third group with the combination of both treatments. The investigators
      hypothesize that VAS scores for pain (especially shoulder pain), and MEDD usage will differ
      between groups. Wound infection incidence and time spent in PACU are also expected to differ.
      Fibrinolytic activity in the peritoneal fluid is expected to be higher in patients undergoing
      laparoscopic procedures with humidified gas insufflation, since the trauma to the peritoneum
      will be less.
    

Detailed description: 
      During the first 30 to 40 minutes of anaesthesia, a patient's temperature can drop to below
      35.0°C. Reasons for this include loss of the behavioural response to cold and the impairment
      of thermoregulatory heat-preserving mechanisms under general or regional anaesthesia,
      anaesthesia-induced peripheral vasodilation, the use of cold dry insufflation gases. For
      these reasons, institutions employ a range of techniques to prevent hypothermia, including
      forced air warming (peri-operatively), use of warmed intravenous fluids, temperature
      monitoring and control of room temperature. Despite these interventions audits demonstrate
      that 20-56% of patients are hypothermic during the perioperative period. A factor often
      dismissed as a cause of peri-operative hypothermia during laparoscopic procedures is dry and
      cold insufflation gas. During laparoscopic procedures the abdomen is continuously insufflated
      with cold, dry CO2 resulting in desiccation and heat loss which consequently induces
      hypothermia in the patient. Clinical evidence suggests that the risk of hypothermia can be
      reduced using warm and humidified gas, as has been shown in animal models, in clinical trials
      and confirmed in a metaanalysis in humans. Only gas at body temperature and fully saturated
      with moisture will prevent loss of energy from the peritoneum surface - because it is
      physically not possible to evaporate fluids into a fully saturated gas. Therefore, the fluid
      layer will be maintained, minimizing energy loss from the body, decreasing the hypothermia
      induced by the evaporative losses in laparoscopic surgery and stabilizing the fibrinolytic
      activity of the peritoneum. The aim of this investigation is to assess the impact of forced
      air warming, warm humidified insufflation gas and the combination of the two on
      intraoperative temperature maintenance and the postoperative pain course as well as the
      fibrinolytic activity in peritoneal fluid following laparoscopic procedures (duration > 60
      min) in a prospective, randomized, controlled, mono-centric study. Therefore 150 subjects
      will be randomized in 3 groups of 50 subjects each. First group will be treated with
      forced-air warming blanket (bair hugger). Second group will be treated with warmed,
      humidified insufflation via the F&P HumiGard™ Surgical Humidification System. Third group
      will be treated with both, warming blankets and warmed, humidified insufflation. The
      peri-operative temperature of patients might be higher in patients of the third group with
      the combination of both treatments. The investigators hypothesize that VAS scores for pain
      (especially shoulder pain), and MEDD usage will differ between groups. Wound infection
      incidence and time spent in PACU are also expected to differ. Fibrinolytic activity in the
      peritoneal fluid is expected to be higher in patients undergoing laparoscopic procedures with
      humidified gas insufflation, since the trauma to the peritoneum will be less.
    

Intervention name(s): 3M™ Bair Hugger™; F&P HumiGard™ Surgical Humidification System
Intervention type(s): Device; Device
Intervention description(s): forced-air warming blanket; warmed, humidified insufflation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Treatment