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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:
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B | Active Comparator | Administration of ropivacaïne 0,2% by direct intra-abdominal administration at the end of the surgery |
|
| C | Active Comparator | 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% |
|
| A | Placebo Comparator | 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% |
|
| D | Placebo Comparator | Administration of Nacl 0,9% by direct intra-abdominal administration at the end of the surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pierre DIEMUNSCH, MD | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sihcus-Cmco | Schiltigheim | 67300 | France | |||
| Hôpital de Hautepierre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18633034 | Result | 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. |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D007035 | Hypothermia |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| Aeroneb® Pro (Nektar® Company) | Device | The Aeroneb® Pro (Nektar® Company) permits cold and dry nebulization without saline solution neither ropivacaïne (Naropéine) during the surgical procedure. |
|
| Surgical comfort | During the duration of the surgical procedure. |
| Strasbourg |
| 67098 |
| France |
| Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL | Monza | 20051 | Italy |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001832 | Body Temperature Changes |