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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00372268
First received: September 5, 2006
Last updated: April 12, 2012
Last verified: April 2012

September 5, 2006
April 12, 2012
January 2006
October 2011   (final data collection date for primary outcome measure)
  • 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
Complete list of historical versions of study NCT00372268 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
 
Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery
Evaluation of the Effects of Conditioning of Insufflated Gas on the Core Temperature and the 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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
248
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France,   Italy
 
NCT00372268
3621
No
University Hospital, Strasbourg, France
University Hospital, Strasbourg, France
Not Provided
Principal Investigator: Pierre DIEMUNSCH, MD Hôpitaux Universitaires de Strasbourg
University Hospital, Strasbourg, France
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP