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NCT Number: NCT00372268

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

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).

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sihcus-Cmco, Schiltigheim, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aeroneb® Pro (Nektar® Company)

Device

The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.

Primary outcomes

  1. Evolution of core temperature

    Time frame: From the beginning of the anesthetic procedure to the discharge of the recovery room.

  2. Post-operative pain

    Time frame: From the arrival in the recovery room to the 6th post-operative day.

Secondary outcomes

  1. 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)

  2. Quality of life

    Time frame: From the discharge of the recovery room to the 6th post-operative day

  3. Surgical comfort

    Time frame: During the duration of the surgical procedure.

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2011
Study completion
2011
First posted
Sep 6, 2006
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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