Clinical trial NCT00372268: Effects of Insufflated Gas on Core Temperature and Post-operative Pain During Laparoscopic Surgery
Official title: Evaluation of the Effects of Conditioning of Insufflated Gas on the Core Temperature and the Post-operative Pain During Laparoscopic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopy
Pain, Postoperative
Hypothermia
Keywords: Comparison of four conditionings of the insufflated gas during laparoscopy and their consequences on the core temperature and the post-operative pain.
Women with womb pathology needing laparoscopic surgery
No emergency
Aged over 18 years
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2006-09-06
Enrollment: 248
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Evolution of core temperature
timeFrame: From the beginning of the anesthetic procedure to the discharge of the recovery room.
measure: Post-operative pain
timeFrame: From the arrival in the recovery room to the 6th post-operative day.
Secondary outcomes:
measure: Inflammation parameters
timeFrame: 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)
measure: Quality of life
timeFrame: From the discharge of the recovery room to the 6th post-operative day
measure: Surgical comfort
timeFrame: During the duration of the surgical procedure.
Other outcomes:
Locations:
city: Schiltigheim
country: France
facility: Sihcus-Cmco
city: Strasbourg
country: France
facility: Hôpital de Hautepierre
city: Monza
country: Italy
facility: Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Pierre DIEMUNSCH, MD
role: PRINCIPAL_INVESTIGATOR
References: