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

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00372268
• Other study ID #: 3621
• Status: Completed
• Phase: N/A
• First received: September 5, 2006
• Last updated: April 12, 2012
• Start date: January 2006
• Est. completion date: October 2011

Study information

• Verified date: April 2012
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia
• Laparoscopy
• Pain, Postoperative

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Sihcus-Cmco	Schiltigheim
France	Hôpital de Hautepierre	Strasbourg
Italy	Department of Perioperative Medicine and Intensive Care - SAN GERARDO HOSPITAL	Monza

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Countries where clinical trial is conducted

France,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evolution of core temperature		From the beginning of the anesthetic procedure to the discharge of the recovery room.	Yes
Primary	Post-operative pain		From the arrival in the recovery room to the 6th post-operative day.	Yes
Secondary	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)	Yes
Secondary	Quality of life		From the discharge of the recovery room to the 6th post-operative day	No
Secondary	Surgical comfort		During the duration of the surgical procedure.	Yes