Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery
NCT ID: NCT00372268
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
248 participants
INTERVENTIONAL
2006-01-31
2011-10-31
Brief Summary
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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).
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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B
Administration of ropivacaïne 0,2% by direct intra-abdominal administration at the end of the surgery
Aeroneb® Pro (Nektar® Company)
The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.
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%
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.
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%
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.
D
Administration of Nacl 0,9% by direct intra-abdominal administration at the end of the surgery
Aeroneb® Pro (Nektar® Company)
The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.
Interventions
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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.
Aeroneb® Pro (Nektar® Company)
The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.
Eligibility Criteria
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Inclusion Criteria
* Female
* Aged over 18 years
* No emergency
Exclusion Criteria
* Protocol rejected by the patient
* Request of the surgeon or the anesthesiologist to know the administration solution or the insufflated gas
18 Years
FEMALE
No
Sponsors
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University Hospital, Strasbourg, France
OTHER
Responsible Party
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Principal Investigators
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Pierre DIEMUNSCH, MD
Role: PRINCIPAL_INVESTIGATOR
Hôpitaux Universitaires de Strasbourg
Locations
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Sihcus-Cmco
Schiltigheim, , France
Hôpital de Hautepierre
Strasbourg, , France
Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL
Monza, , Italy
Countries
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References
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Greib N, Schlotterbeck H, Dow WA, Joshi GP, Geny B, Diemunsch PA. An evaluation of gas humidifying devices as a means of intraperitoneal local anesthetic administration for laparoscopic surgery. Anesth Analg. 2008 Aug;107(2):549-51. doi: 10.1213/ane.0b013e318176fa1c.
Other Identifiers
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3621
Identifier Type: -
Identifier Source: org_study_id