Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery

• Evolution of core temperature [ Time Frame: From the beginning of the anesthetic procedure to the discharge of the recovery room. ] [ Designated as safety issue: Yes ]
• Post-operative pain [ Time Frame: From the arrival in the recovery room to the 6th post-operative day. ] [ Designated as safety issue: Yes ]

• Evolution of core temperature
• Post-operative pain

• Inflammation parameters [ Time Frame: From the beginning of the anesthetic procedure to the end of the surgical procedure (one blood sample is done before the surgery, the second is done just after the arrival in the recovery room) ] [ Designated as safety issue: Yes ]
• Quality of life [ Time Frame: From the discharge of the recovery room to the 6th post-operative day ] [ Designated as safety issue: No ]
• Surgical comfort [ Time Frame: During the duration of the surgical procedure. ] [ Designated as safety issue: Yes ]

• Inflammation parameters
• Quality of life
• Surgical comfort

During laparoscopy, administration of cold and dry carbon dioxide (CO2) leads to hypothermia. Different types of gas conditioning have been studied in order to prevent this specific hypothermia. Intra-abdominal administration of local anesthetics has also been studied in order to prevent post-operative pain. In both cases, some results have been described.

The investigators propose to evaluate in a prospective, randomized, double blind trial, the impact of 4 different types of conditioning of insufflated gas during laparoscopy for womb surgery on hypothermia prevention and post-operative pain. These 4 types of gas conditioning are:

• CO2 wet and cold with nebulized Nacl and direct intra-abdominal administration of Nacl
• CO2 wet and cold with nebulized ropivacaïne 0.75% and direct intra-abdominal administration of Nacl
• CO2 dry and cold with direct intra-abdominal administration of ropivacaïne 0.2%
• CO2 dry and cold with direct intra-abdominal administration of Nacl

The investigators use a new device (Aeroneb® Pro [Aerogen® Company]) which can wet (by nebulization) the insufflated gas and therefore permits intraperitoneal medicament administration (local anesthetics).

• Laparoscopy
• Pain, Postoperative
• Hypothermia

• Device: Aeroneb® Pro (Nektar® Company)
  The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.
• Device: Aeroneb® Pro (Nektar® Company)
  The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.

• Active Comparator: B
  Administration of ropivacaïne 0,2% by direct intra-abdominal administration at the end of the surgery
  Intervention: Device: Aeroneb® Pro (Nektar® Company)
• Active Comparator: C
  Administration of ropivacaïne 0,75% by nebulization in the insufflated gas during all the surgical procedure with direct intra-abdominal administration of Nacl 0,9%
  Intervention: Device: Aeroneb® Pro (Nektar® Company)
• Placebo Comparator: A
  Administration of Nacl 0,9% by nebulization in the insufflated gas during all the surgical procedure with direct intra-abdominal administration of Nacl 0,9%
  Intervention: Device: Aeroneb® Pro (Nektar® Company)
• Placebo Comparator: D
  Administration of Nacl 0,9% by direct intra-abdominal administration at the end of the surgery
  Intervention: Device: Aeroneb® Pro (Nektar® Company)

Inclusion Criteria:

• Womb surgery by laparoscopy
• Female
• Aged over 18 years
• No emergency

Exclusion Criteria:

• Laparotomy
• Protocol rejected by the patient
• Request of the surgeon or the anesthesiologist to know the administration solution or the insufflated gas