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

Study Overview
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Brief Summary
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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).

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

Conditions
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Laparoscopy, Pain, Postoperative, Hypothermia

Intervention / Treatment
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* Device: Aeroneb® Pro (Nektar® Company)
* Device: Aeroneb® Pro (Nektar® Company)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: B<br>Administration of ropivacaïne 0,2% by direct intra-abdominal administration at the end of the surgery | Device: Aeroneb® Pro (Nektar® Company)<br>* The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.<br>|
| Active Comparator: C<br>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% | Device: Aeroneb® Pro (Nektar® Company)<br>* The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.<br>|
| Placebo Comparator: A<br>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% | Device: Aeroneb® Pro (Nektar® Company)<br>* The Aeroneb® Pro (Nektar® Company) permits cold and wet nebulization of either saline solution or ropivacaïne 0.75% (Naropeine) during the surgical procedure.<br>|
| Placebo Comparator: D<br>Administration of Nacl 0,9% by direct intra-abdominal administration at the end of the surgery | Device: Aeroneb® Pro (Nektar® Company)<br>* The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of core temperature |  | From the beginning of the anesthetic procedure to the discharge of the recovery room. | 
| Post-operative pain |  | From the arrival in the recovery room to the 6th post-operative day. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammation parameters |  | 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) | 
| Quality of life |  | From the discharge of the recovery room to the 6th post-operative day | 
| Surgical comfort |  | During the duration of the surgical procedure. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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