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

University Hospital, Strasbourg, France

Status: Completed

Conditions: Laparoscopy; Pain, Postoperative; Hypothermia

Treatments: Device: Aeroneb® Pro (Nektar® Company)

Study type: Interventional

Funder types: Other

Identifiers

NCT00372268

3621

Details and patient eligibility

About

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).

Enrollment: 248 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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248 participants in 4 patient groups, including a placebo group

B

Active Comparator group

Description:

Administration of ropivacaïne 0,2% by direct intra-abdominal administration at the end of the surgery

Treatment:

Device: Aeroneb® Pro (Nektar® Company)

Device: Aeroneb® Pro (Nektar® Company)

C

Active Comparator group

Description:

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%

Treatment:

Device: Aeroneb® Pro (Nektar® Company)

Device: Aeroneb® Pro (Nektar® Company)

A

Placebo Comparator group

Description:

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%

Treatment:

Device: Aeroneb® Pro (Nektar® Company)

Device: Aeroneb® Pro (Nektar® Company)

D

Placebo Comparator group

Description:

Administration of Nacl 0,9% by direct intra-abdominal administration at the end of the surgery

Treatment:

Device: Aeroneb® Pro (Nektar® Company)

Device: Aeroneb® Pro (Nektar® Company)